A targeted biofilm management approach was introduced, using a single 60-second application of DEBRICHEM® to remove biofilm and necrotic tissue. The study, A Desiccation Compound As A Biofilm- and Necrosis-Removing Agent: A Case Series, presents compelling results that reinforce the broad-spectrum effectiveness of DEBRICHEM® in accelerating wound bed preparation and improving healing outcomes.

The impact was significant:

All wounds, previously unresponsive to treatment, began progressing toward healing.

92.5% achieved complete granulation—a critical milestone in the healing process—within an average of 36.2 days.

100% of venous leg ulcers (VLUs), post-traumatic lesions, vascular ulcers, and ischemic ulcers achieved full granulation.

80% of diabetic foot ulcers (DFUs), including Wagner III & IV cases, also fully granulated.

All wounds were clinically free of biofilm and necrotic tissue within 7 days.

No adverse events were reported, confirming safety and ease of use.

For wounds that had remained unchanged for months, this intervention was a critical turning point. By effectively eliminating biofilm and necrotic tissue, DEBRICHEM® created an optimal wound bed environment, allowing the healing process to resume.

Why Does This Matter?

The clinical challenges presented in the study are closely linked to the rising costs of chronic wound care. Let’s take a look at what these are:

Long Healing Times & High Recurrence Rates

Many wounds fail to heal quickly and frequently reopen after treatment, requiring extended care and increasing overall healthcare costs. The longer a wound remains open, the more resources are needed, further adding to the financial strain.

Hospitalization & surgical procedures are among the biggest cost drivers, particularly for DFUs and VLUs.

In the U.S. alone:

• DFU treatment costs $9–13 billion/year, with hospital stays contributing significantly.
• VLUs add an average of $6,391 per patient/year, making them a major economic burden.

Hyperinflammation & Infection

A key factor complicating wound healing is persistent inflammation and infection, which prolong recovery and demand frequent medical interventions, leading to added costs. Biofilms—bacterial layers that form within wounds—resist antibiotics and antiseptics, making infections more difficult to treat and increasing the need for aggressive therapies.

Need for Continuous Debridement

Another major cost driver is the need for continuous debridement to remove necrotic tissue and biofilm, both of which are critical for wound healing. Moreover, traditional debridement methods (surgical, enzymatic, biological) are:

• Expensive
• Specialist-dependent
• Painful & slow (requiring multiple procedures)

DEBRICHEM® addresses these issues with its single, fast-acting 60-second application that helps restart the healing cascade and reduces the need for ongoing, costly interventions.

How Does DEBRICHEM® Works?

DEBRICHEM® works through a targeted biochemical reaction with water in the biofilm, releasing an impressive amount of energy—approximately 1500 kJ/mol. This energy denatures and carbonizes the biofilm’s extracellular polymeric substance (EPS), breaking down its structure and destroying its contents. Over time, the denatured and carbonized material detaches from the wound surface. As it remains in place initially, granulation tissue begins to form underneath, creating the foundation for healing. By eliminating the biofilm barrier, DEBRICHEM® facilitates granulation and reopens the natural path to wound recovery.

Objective of the Study

Assessing these effects in clinical settings, the study: A Desiccation Compound As A Biofilm- and Necrosis-Removing Agent: A Case Series evaluated:

The effectiveness of a one-time application of DEBRICHEM® in achieving a clean wound bed.

Measure the extent and speed of granulation tissue formation as an indicator of successful biofilm and necrosis removal.

Evaluate patient and clinician experience, including pain levels, tolerance, and satisfaction compared to prior treatments.

Ensure safety by monitoring for adverse effects related to DEBRICHEM® application.

Study Location and Ethical Considerations

The study was conducted at Villa Berica Hospital in Vicenza, Italy. It received ethical approval from the hospital’s ethical committee in accordance with the principles outlined in the Declaration of Helsinki. Furthermore, informed consent was obtained from all participants, with each patient signing a consent form prior to taking part in the study.

Study Methodology

A structured approach was followed in the study to ensure a standardized method for evaluating DEBRICHEM®’s performance as a biofilm- and necrosis-removing agent in chronic wound care. At the start of the study, none of the lesions had any granulation tissue coverage, further emphasizing the severity and complexity of the wounds being treated. A total of 54 patients were included based on the following criteria:

Patient Selection Criteria

Inclusion Criteria:

• Patients 18 years or older
• Wounds present for at least four weeks
• Wound location: Lower leg or foot
• One wound per patient (if multiple wounds, the largest was selected)

Exclusion Criteria:

• No specific exclusion criteria were mentioned, apart from standard protocol violations and missing/incomplete data.

Wound Types

The treated wounds comprised various types, including:

• 22 Venous Leg Ulcers (VLUs)
• 20 Diabetic Foot Ulcers (DFUs) (Wagner Grade I–IV)
• 9 Post-Traumatic Hard-to-Heal Lesions
• 2 Vascular Ulcers
• 1 Ischemic Ulcer

Lesion Size and Volume in the Study

Key details about lesion size and volume are as follows:

• Mean surface area of all lesions: 57.4 cm² (range: 2–400 cm²).
• VLUs: Average area of 83.2 cm² (range: 2–400 cm²)
• DFUs: Average area of 43.4 cm² (range: 3–175 cm²)
• Post-traumatic lesions: Average area of 15.9 cm² (range: 2–40 cm²)
• Vascular ulcers: Measured at 40 cm² and 200 cm².
• Ischemic ulcer: Measured at 20 cm².
• Wound volume (for Wagner III and IV ulcers): Average volume of 33.9 cm³ (range: 3–100 cm³).

Lesion Duration

• The venous leg ulcers (VLUs) had an average duration of 5.3 months (range: 1–12 months).
• The diabetic foot ulcers (DFUs) had an average duration of 3.7 months (range: 1–12 months).
• The post-traumatic lesions had an average duration of 5.6 months (range: 2–12 months).
• The two vasculitis ulcers and the ischemic ulcer were each three months old.

Concomitant Diseases

The study participants collectively had a total of 73 concomitant diseases, which refers to the total number of additional medical conditions that patients experienced alongside their chronic wounds. Since some patients had multiple conditions, this number represents the cumulative total rather than 73 different diseases.

Examples of these underlying health issues included:

• Hypertension (high blood pressure)
• Neuropathy (nerve damage, common in diabetes)
• Congestive heart failure
• Peripheral arterial disease (poor blood flow)
• Chronic kidney disease
• Severe obesity
• Coronary artery disease (heart disease)
• Atrial fibrillation (irregular heartbeat)

These additional medical conditions can slow down wound healing, increase the risk of complications, and make treatment more challenging.

Treatment Procedure

The treatment process involved the following steps:

1⃣ Wound Cleansing: Basic cleaning of the wound and the surrounding skin.

2⃣ Application of DEBRICHEM®: The agent was applied directly to the wound and extended 1 cm beyond the periwound skin for 60 seconds.

3⃣ Rinsing and Removal: DEBRICHEM® was diluted and washed off with sterile water or saline.

4⃣ Post-Treatment Care: A Vaseline gauze dressing was applied to avoid interference from healing-promoting products.

Treatments like compression therapy for VLUs and offloading devices for DFUs were implemented as needed.

Follow-Up

• Patients returned weekly for evaluation.
• No antibiotics or additional debridement were used during follow-up.

Outcome Measurements

The primary outcome of the study was the formation of granulation tissue, measured as both a percentage and the time required to achieve complete granulation.

This outcome was visually evaluated as an indicator of the successful removal of biofilm and necrotic tissue and the wound’s progress toward healing.

Secondary outcomes included:

• Pain Levels: Assessed using a Visual Analog Scale (VAS), where 0 = no pain and 5 = very painful.
• Comparison to Previous Treatments: Both patients and healthcare providers rated the effectiveness of DEBRICHEM® compared to previous methods used.
• Safety: Any adverse effects related to the use of DEBRICHEM® were carefully documented to evaluate the product’s safety and tolerability.

This comprehensive approach provided a well-rounded perspective on the efficacy, safety, and patient experience associated with DEBRICHEM® in managing hard-to-heal wounds.

All Results from the Study

Granulation Success Rates:

• 100% of VLUs, post-traumatic lesions, vascular ulcers, and the ischemic ulcer reached complete granulation.
• 80% of DFUs (16 out of 20) achieved complete granulation, despite being Wagner III & IV ulcers, which are notoriously difficult to heal.
• The average time to granulation was 36.2 days, varying by wound type:
• VLUs: 31.6 days (range: 7–95 days)
• DFUs: 43.9 days (range: 2–131 days)
• Post-Traumatic Lesions: 34.1 days (range: 7–72 days)
• Vascular Ulcers: 12–14 days
• Ischemic Ulcer: 61 days

Biofilm & Necrosis Removal:

• All wounds were free of clinical signs of biofilm and necrosis within 7 days post-treatment.
• The desiccation effect led to rapid separation of necrotic material, leaving a clean wound bed.

Pain & Tolerance:

• Procedural pain: Average 1.9/5 on a Visual Analog Scale (VAS), with 15 diabetic patients reporting no pain due to neuropathy.
• Post-procedure pain (Day 1): 0.2/5, with 48 patients reporting no pain.

Patient & Physician Satisfaction:

• Physicians’ rating: 83% (45/54) rated it substantially better.
• Patients’ rating compared to previous treatments: 67% (36/54) found it substantially better.

Adverse Events:

• No adverse events related to DEBRICHEM® were reported.

From Complexity to Clarity: The DEBRICHEM® Difference

Chronic wounds place an increasing burden on healthcare systems, often requiring long treatment cycles, costly interventions, and specialist care. This study demonstrated that a single 60-second application of DEBRICHEM® can rapidly restart the healing process, even in large, complex wounds that had failed to improve for months.

By effectively removing biofilm and necrotic tissue, DEBRICHEM® accelerates wound bed preparation, making subsequent therapies—such as compression, advanced dressings, and skin grafts—more effective. Its broad-spectrum efficacy across different wound types simplifies treatment while ensuring consistent, reliable outcomes.

For wounds that remained unchanged for months, this intervention was the turning point. DEBRICHEM® helped transform non-healing wounds into wounds ready to heal.

For Distributors: Looking to bring a proven, reliable debridement solution to your market? Contact us to discuss partnership opportunities: info@debx-medical.com

For Clinicians: See how DEBRICHEM® can improve your wound care practice. Request a demo today: https://www.debx-medical.com/request-a-demonstration/

The post Broad-Spectrum Success of DEBRICHEM®: A Versatile & Adaptable Solution For Complex Wounds, Study Confirms appeared first on Innovating The Future of Wound Care.

However, persistent challenges such as re-infection and antibiotic resistance often undermine the efforts placed in wound bed preparation. These challenges lead to multiple treatment sessions which may result in patient non-compliance.

But what if a single treatment could counter these challenges? A solution that prevents re-infection, counters antibiotic resistance, eliminate the necessity for multiple treatments, and improves patient compliance for wounds of different etiologies, all at the same time.

Sounds ambitious? Let’s explore the study that established the working mechanism of this solution called DEBRICHEM®. Published in Wounds, study is titled: Restarting the Healing Process of Chronic Wounds Using a Novel Desiccant: A Prospective Case Series, and here are its key results:

Powerful Antimicrobial Action: DEBRICHEM® inhibited the growth of 7 key wound pathogens (bacteria & fungi), with a 54 mm ± 5 mm inhibition zone.

Rapid Wound Granulation: All patients achieved 100% granulation, with a median granulation time of 20.5 days.

Effective Across Multiple Ulcer Types: The treatment successfully restarted healing in diabetic, venous, ischemic, vasculitic, and post-traumatic ulcers.

Immediate Biofilm & Necrotic Tissue Removal: The agent enabled instant coagulation of wound debris.

Macrophage Activation: Stimulated the immune response, accelerating natural wound healing mechanisms.

These impressive results are rooted in DEBRICHEM®’s ability to target the shared mechanism that blocks wound healing, which is common across chronic wounds with different etiologies.

What Is The Shared Mechanism That Blocks Wound Healing?

The shared mechanism that blocks wound healing is rooted in chronic, uncontrolled inflammation and the disruption of normal cellular activities, both driven by a hostile wound environment. A persistent microbial burden and drug-resistant biofilm primarily shape this environment.

Persistent microbial burden refers to the continuous presence and accumulation of bacteria and fungi in the wound. Over time, these microbes organize into biofilms—structured communities encased in a protective extracellular matrix. This matrix shields the microbes from antimicrobial treatments and immune responses, making the biofilm highly drug-resistant.

Together, persistent microbial burden and biofilm formation continuously trigger the immune system, causing an overproduction of inflammatory cytokines and enzymes that damage healthy tissue. This doesn’t stop until the complete elimination of biofilm. As a result, the natural wound-healing process stops, preventing the wound from transitioning through the critical phases of inflammation, proliferation, and tissue remodeling.

Persistent Microbial Burden & Drug-Resistant Biofilm Promote a Vicious Cycle

These mechanisms do not act in isolation. Instead, they create a vicious cycle:

• Persistent microbial burden fuels biofilm formation, providing an ideal environment for microbial communities to grow and protect themselves.
• In turn, biofilms sustain chronic inflammation and infection while shielding pathogens from treatment and immune defenses.
• This leads to continuous immune activation, causing further tissue damage, which fosters even more microbial growth.

This self-sustaining cycle is the key reason why chronic wounds fail to heal despite conventional treatments.

What Does It Mean to “Restart” Wound Healing?

Restarting the wound healing process means breaking this vicious cycle, shifting a chronic wound—stuck in a state of persistent inflammation and stalled tissue repair—back into an active, progressive healing phase. This shift is enabled by:

• Elimination of biofilm
• Destruction of microbial burden
• Reactivation of immune cells
• Formation of healthy granulation tissue

How Does DEBRICHEM® Restarts Wound Healing?

DEBRICHEM® works through a targeted biochemical reaction with water in the biofilm, releasing an impressive amount of energy—approximately 1500 kJ/mol. This energy denatures and carbonizes the biofilm’s extracellular polymeric substance (EPS), breaking its structure and eliminating its barrier. Over time, the denatured and carbonized material detaches from the wound surface. As it remains in place initially, granulation tissue begins to form underneath, creating the foundation for healing. By eliminating the biofilm barrier, DEBRICHEM® facilitates granulation and reopens the natural path to wound recovery.

To understand if DEBRICHEM® could facilitate the shift from inflammatory phase to healing phase, the focus study of this article employed a comprehensive approach, evaluating its impact both in controlled laboratory conditions and real-world clinical settings.

Two-Pronged Approach: Study Model

This study followed a two-pronged approach to establish the working mechanism of DEBRICHEM®, focusing on both antimicrobial activity (in vitro) and clinical wound healing outcomes (in vivo). The research was conducted at Villa Berica Hospital, Italy, involving patients with chronic wounds of different etiologies.

1. In Vitro Antimicrobial Testing: Assessing Pathogen Inhibition

To determine its antimicrobial properties, DEBRICHEM® was tested against seven key pathogens, including both Gram-positive and Gram-negative bacteria, commonly found in chronic wounds and biofilms:

• Staphylococcus aureus
• Escherichia coli
• Pseudomonas aeruginosa
• Enterococcus hirae
• Candida albicans
• Tannerella forsythia
• Porphyromonas gingivalis

A 50 μL sample of DEBRICHEM® was placed at the center of Tryptone Soy Agar (TSA) plates inoculated with these microbes. After 24 hours of incubation at 37°C, the diameter of the inhibition zone was measured.

2. In Vivo: Evaluating Wound Healing Progression

To assess the clinical impact of DEBRICHEM®, a prospective case series was conducted on patients with chronic wounds of various etiologies, including diabetic ulcers, venous ulcers, ischemic wounds, vasculitis-related ulcers, and post-traumatic ulcers.

Patient Selection Criteria

Inclusion Criteria:

• Chronic wounds ≥6 weeks old.
• No critical limb ischemia unless revascularized.
• No active systemic infection requiring antibiotics.

Exclusion Criteria:

• Purulent abscesses requiring surgical evacuation.
• Cancer-related ulcers.
• Nonrevascularized critical limb ischemia
• Fever or sepsis indicating candidacy for systemic antibiotic treatment

Treatment Protocol: DEBRICHEM® Application & Wound Management

The study followed a standardized wound treatment protocol to ensure consistency across cases.

1⃣ Wound Preparation

• Previous dressings and medications were removed.
• The wound was cleaned with saline and dried.
• Any loosely attached necrotic tissue was gently removed with dry gauze.

2⃣ Application of DEBRICHEM®

• The agent was evenly spread (~3mL per 100 cm²) with a gloved finger.
• It remained in contact for up to 60 seconds before being rinsed with saline.
• A 1 cm margin of surrounding healthy skin was also treated to reduce the risk of new contamination of the wound bed by migrating pathogens.

3⃣ Post-Treatment Care

• After approximately 60 seconds, the wound bed and margin were rinsed with saline.
• The wound bed was rubbed with dry sterile gauze to remove the detachable material.
• It was then covered with sterile Fitostimoline soaked gauze.
• No other medication was allowed.
• A light bandage or a compression stocking was applied when necessary.

Follow-Up & Clinical Outcomes

Patients were monitored weekly for six weeks, with additional visits if exudation, pain, or infection occurred. Following outcomes were measured:

• Primary Outcome: Time to 100% granulation tissue formation.
• Secondary Outcomes:Reduction in necrotic tissue and slough.Wound size reduction over time.Patient tolerance and side effects.Need for additional applications or alternative debridement methods.

Presence of good granulation, epidermal tissue growing from wound edges, and the absence of non vital debris and infection was used to point out movement of wounds towards healing.

Results: Evidence Behind the Transformation

The clinical and laboratory findings collectively illustrate how DEBRICHEM® disrupts the cycle of chronic wound stagnation. From its immediate antimicrobial action to its long-term effects on wound healing progression, each result reflects the agent’s ability to restart the healing process effectively.

1. Antimicrobial Activity (In Vitro)

• Significant inhibition zone (54 mm ± 5 mm) was observed against 7 key pathogens, including Gram-positive and Gram-negative bacteria and fungi, demonstrating strong antimicrobial properties.
• This indicates its ability to work against persistent microbial burden.

2. Immediate Effects: What Happened Right After Application?

Upon applying DEBRICHEM® to the wound bed for 60 seconds, two distinct reactions were observed, depending on the wound type and severity:

1⃣ Coagulation & Instant Debridement

• The necrotic material and slough instantly coagulated.
• After rinsing with saline and wiping with a gauze, the majority of dead tissue and biofilm was easily removed, exposing healthy, viable tissue underneath.
• The surrounding skin was left unaffected, with no redness, vesicles, or irritation.

2⃣ Coagulation Without Immediate Detachment

• The necrotic tissue and biofilm coagulated but remained attached to the wound.
• Some areas showed mild spot bleeding, stopped easily with gentle pressure.
• The coagulated material eventually resolved over time as part of the body’s natural healing response.

What Happened Over Days to Weeks?

In the following days and weeks, the impact of DEBRICHEM® became more evident as wounds transitioned into granulation and tissue repair phases.

1⃣ Wound Cleansing & Natural Debridement

• By the follow-up, wounds were cleaner and the status of all wounds was judged to be in the healing phase.
• For wounds where coagulated material didn’t immediately detach, it gradually resolved over a few days, likely due to reactivated macrophages and immune responses.
• No additional applications of DEBRICHEM® were required for any patient.

2⃣ Granulation Tissue Formation & Healing Progression

• In all cases, the wound bed progressively transitioned to full granulation tissue.
• The median time to full granulation was 20.5 days (range: 7–78 days).
• Males healed faster (median: 14 days) than females (median: 45 days).
• The final wound size at 100% granulation was the same or slightly reduced compared to baseline.

3. Side Effects

• No serious adverse events (no nodules, welts, or blisters).

A Paradigm Shift in Chronic Wound Care

Chronic wounds have long challenged clinicians with their complexity, resistance to treatment, and the toll they take on patients’ lives. But the data from this study signals a shift—a single treatment that disrupts the vicious cycle of persistent microbial burden and biofilm, reigniting the natural healing process in just 60 seconds.

DEBRICHEM® is not just another wound care product. It’s a science-backed solution that has demonstrated:

• Powerful anti-biofilm activity without relying on antibiotics.
• Consistent results across multiple wound types.
• Improved patient compliance due to its single-application effectiveness.

If you’re a clinician seeking faster, more reliable outcomes for your patients, it’s time to consider DEBRICHEM®. Not because it promises quick fixes, but because it delivers a wound bed ready for granulation and subsequent treatments.

Contact us for clinical demonstrations and case studies. https://www.debx-medical.com/request-a-demonstration/.

If you are a distributor and interested in bringing DEBRICHEM® to your market? Let’s collaborate. Email us at info@debx-medical.com

Download the focus study of this article here: https://www.debx-medical.com/scientific-papers/

The post Powerful Anti-Biofilm Agent Restarts Wound Healing in 60 Seconds, Shows Study appeared first on Innovating The Future of Wound Care.

Reaching granulation in wounds like Diabetic Foot Ulcers (DFUs), Carbuncles, and Dehiscent Wounds is not easy. It requires skilled professionals, repetitive procedures, and high costs. Effective debridement—removal of biofilm and necrotic tissue—is a primary prerequisite for effective granulation in these wounds.

DEBRICHEM® is an innovative single-use debridement agent that effectively targets and eliminates biofilm and non-viable tissue in just 60 seconds, creating an optimal environment for granulation tissue formation. Its application does not require specialized skills or equipment, making it suitable for use in any medical setting and simplifying wound care procedures.

According to a study conducted at the Wound Care Unit, Hospital Kuala Lumpur, where DEBRICHEM® was applied to debride DFUs, Carbuncles, and Dehiscent Wounds, patients reached granulation in an average of just over 3 weeks. The maximum duration of wounds in this study was 24 weeks, while the largest lesion size treated with DEBRICHEM® was 72 cm².

This LinkedIn article draws inspiration from this study performed in Malaysia.

Key Results of the Study:

Effective Debridement: Successful debridement of DFUs, carbuncles, and dehiscent wounds in 60 seconds.

Rapid Granulation: All patients reached granulation within an average of just 3.17 weeks.

Safe and Reliable: No adverse effects such as excessive bleeding, burns, or rashes. Surrounding healthy tissue was unaffected.

Cost-Effective: Reduced hospital stays and minimized need for surgical interventions.

Challenge of The Study: Carbuncles, Diabetic Foot Ulcers, and Dehiscent Wounds

Diabetic Foot Ulcers

DFUs are a common complication of diabetes, often caused by neuropathy and poor blood circulation. They carry severe risks, including:

• Limb Amputations: Persistent infections and poor wound healing can necessitate partial or complete limb removal.
• Increased Healthcare Costs: Managing DFUs is resource-intensive, with annual treatment costs 23% higher in private settings than in public settings, in Malaysia (Nair et al., 2017).
• Reduced Quality of Life: Chronic pain, mobility issues, and the psychological burden of chronic illness significantly impact patients’ daily lives.

Carbuncles

A carbuncle is a cluster of interconnected furuncles (boils) caused by a bacterial infection, typically Staphylococcus aureus. These infections are characterized by multiple pus-filled cavities connected under the skin, leading to:

• Severe Pain and Discomfort: Carbuncles can be intensely painful and may cause systemic symptoms such as fever and malaise.
• Delayed Healing: Biofilms within carbuncles make them resistant to standard antimicrobial treatments, complicating the healing process.
• Risk of Spread: Without effective treatment, the infection can spread to surrounding tissues, increasing the risk of more serious complications.

Dehiscent Wounds

Wound dehiscence refers to the reopening of a previously closed wound, often due to inadequate healing or excessive tension on the wound edges. This condition poses several challenges:

• Increased Infection Risk: Open wounds are more susceptible to bacterial invasion, leading to infections that can impede healing.
• Prolonged Healing Time: Dehiscent wounds require additional interventions to close, extending the overall healing period.
• Need for Re-debridement: Reopened wounds often necessitate repeated debridement to remove necrotic tissue and biofilms, increasing the burden on healthcare resources.

The increasing prevalence of diabetes exacerbates the situation, with a substantial rise in related complications, especially in regions like Malaysia.

Major Hurdle to Granulation: Biofilm

A major impediment to granulation in these wounds is the presence of biofilms—slimy, translucent layers of bacteria that resist antimicrobials and antibiotics. Biofilms, often composed of Staphylococcus aureus and Pseudomonas aeruginosa, protect pathogens and hinder the body’s natural healing mechanisms.

Although over 80% of wounds contain biofilm, diagnosing biofilm quickly is challenging. In clinical practice, healthcare professionals typically rely on slough (a secondary effect of biofilm) to determine the need for debridement (Snyder et al., 2017).

How Does Debridement Support Granulation?

Wound healing itself is typically divided into four overlapping phases: hemostasis, inflammation, proliferation (granulation), and remodeling. Debridement supports each of these phases in specific ways, enhancing overall healing outcomes.

It supports granulation phase by eliminating barriers – non-viable and infected tissue – that impede new tissue growth and reduces the risk of infection. This process stimulates the body’s natural healing mechanisms, the migration of vital cells and enhancing the supply of oxygen and nutrients to the wound site.

However, traditional debridement methods often have disadvantages, such as the risk of bleeding, high costs, the requirement for skilled professionals, and the potential for infection (Strohal et al., 2013; Nowak et al., 2022). These challenges can hinder effective wound management and prolong healing times.

How Did the Clinicians Reach Faster Granulation in This Study?

Clinicians achieved this by adopting DEBRICHEM®’s innovative approach to wound debridement, which helps overcome the disadvantages of conventional methods. DEBRICHEM® requires only 60 seconds to achieve effective debridement, facilitating the transition of the wound stalled in the inflammatory phase to active tissue regeneration phase, pushing it towards faster and more reliable healing.

Mode of Action of DEBRICHEM®

DEBRICHEM® works through a targeted biochemical reaction with water in the biofilm, releasing an impressive amount of energy—approximately 1500 kJ/mol. This energy denatures and carbonizes the biofilm’s extracellular polymeric substance (EPS), breaking its structure and eliminating its barrier. Over time, the denatured and carbonized material detaches from the wound surface. As it remains in place initially, granulation tissue begins to form underneath, creating the foundation for healing. By eliminating the biofilm barrier, DEBRICHEM® facilitates granulation and reopens the natural path to wound recovery.

Implementation of DEBRICHEM® in Clinical Practice

The Study spanned 2–4 weeks. It enrolled ambulatory patients from the outpatient clinic who met the inclusion criteria.

Inclusion Criteria:

• Diagnosed with DFU, wound dehiscence, or carbuncle
• Wound surface area of 30 cm² or larger
• Ability to comply with twice-weekly hospital visits

Exclusion Criteria:

• Neoplastic ulcers
• Underlying abscesses or fasciitis requiring incision and drainage
• Underlying osteomyelitis

Clinical Protocol:

1. Preparation: Removed all previous dressings and rinsed any remaining medications with sterile water.
2. Debridement: Gently rubbed necrotic material or slough using sterile gauze with sufficient friction.
3. Drying: The wound bed was thoroughly dried.
4. Anesthesia: Applied Emla cream (lidocaine 2.5% and prilocaine 2.5%) for 10–15 minutes on patients with lower pain tolerance, then wiped off before debridement.
5. Application: DEBRICHEM® was spread evenly over the wound and approximately 1 cm of surrounding healthy skin using a gloved finger. Left on for 60 seconds.
6. Rinsing and Removal: The wound bed was rinsed thoroughly with sterile water and rubbed dry with sterile gauze to remove any detachable material.
7. Dressing: Primary and secondary dressings were applied according to standard care protocols.
8. Monitoring: The lesion’s length, width, and general condition were monitored biweekly during dressing changes until granulation was reached.

Patient Demographics & Wound Condition

The patient demographics were evenly split between males and females, ranging from 63 to 73 years (median age: 69 years). All patients had underlying diabetes mellitus. The duration of wounds before treatment ranged from 2 to 24 weeks (median: 10.5 weeks), and lesion sizes varied from 30 to 72 cm² (median area: 55.25 cm²). Initially, all wounds exhibited sloughy conditions, indicating the presence of biofilms.

Results: Efficacy of DEBRICHEM®

Healing Outcomes:

• Granulation: Reached within 2 to 5 weeks (mean: 3.17 weeks) for all patients.
• Pain Relief: Three patients experienced notable improvement in pre-existing pain. The mild to moderate discomfort during treatment was temporary and entirely resolved within one hour post-treatment.
• No Side Effects: Importantly, no excessive bleeding, nodules, boils, burns, rashes, or lasting pain were observed, emphasizing the safety profile of DEBRICHEM®.
  
  

Conclusion

As the prevalence of diabetes and related complications continues to rise, especially in regions like Malaysia, innovative solutions like DEBRICHEM® become increasingly vital in improving patient outcomes and optimizing wound management practices.

This Malaysian study underscores DEBRICHEM®’s significant role in accelerating granulation and enhancing wound healing outcomes. By swiftly removing biofilms and necrotic tissue within just 60 seconds, DEBRICHEM® creates an optimal environment for new tissue growth, accelerating granulation and leading to faster recovery times. Its easy bedside application simplifies wound care, enhances patient comfort, and reduces healthcare costs by minimizing the need for surgical interventions.

Take the Next Step in Advanced Wound Care

Interested in enhancing wound management strategies?

By adopting DEBRICHEM®, healthcare professionals offer a more effective and patient-friendly debridement option in both outpatient and inpatient settings. Simplify care processes and achieve better healing outcomes today.

Request a complimentary demonstration: https://www.debx-medical.com/request-a-demonstration/

Access the Study: https://www.debx-medical.com/scientific-papers/

#woundcare #patientcare #DEBRICHEM #medicalinnovation

The post Accelerating Granulation in Wound Healing: Insights from a Malaysian Study appeared first on Innovating The Future of Wound Care.

This article will explore:

The fundamentals of Standard of Care.

How T.I.M.E.R.S. came into being and it’s integration into Standard of Care.

T.I.M.E.R.S. framework in detail.

Alignment of DEBRICHEM® with T.I.M.E.R.S. framework.

Fundamentals of Standard of Care

The Standard of Care in wound care represents the clinical practices and guidelines that healthcare professionals adhere to when managing wounds.

Key components of an effective Standard of Care include:

• Early intervention: Timely identification and treatment of wounds improve healing outcomes and reduce complications.
• Accurate assessment and diagnosis: Identifying the underlying cause of the wound and assessing its characteristics (e.g., size, depth, infection) are fundamental in determining the best treatment approach.
• Optimal patient and wound management strategy: Creating a tailored plan that addresses both the patient’s condition and the specific needs of the wound. Implementing local wound care according to T.I.M.E.R.S.
• Appropriately-skilled health professionals: Wound care requires professionals with specialized knowledge and skills to ensure that the right treatments are applied and that the wound is properly managed throughout the healing process.
• Early referral to specialists: In cases where the wound does not respond to primary care measures, timely referral to specialists, such as wound care clinics or multidisciplinary teams, is crucial for optimizing treatment.

Standard of Care is designed to modify risk factors, address underlying pathophysiology, and improve the chances of healing by delivering comprehensive care through a multidisciplinary approach.

Integration of T.I.M.E.R.S. into Standard of Care

The T.I.M.E. framework was initially introduced as a guideline for wound bed preparation, helping clinicians address the core factors that influence wound healing: Tissue, Infection, Moisture, and Edge.

It was based on years of clinical experience and research, which highlighted that certain factors, such as non-viable tissue, infection, and moisture imbalance, consistently impede wound healing.

Over time, clinicians and experts recognized that additional elements, such as regenerative processes and social factors, played a significant role in healing outcomes.

This led to the evolution of T.I.M.E. into T.I.M.E.R.S., adding Regeneration/Repair (R) and Social factors (S) to address the broader factors that contribute to the delayed healing of chronic wounds. This expanded framework better represents the complexities of wound healing, incorporating the biological, psychological, and social dimensions that affect patient outcomes.

The integration of T.I.M.E.R.S. into the Standard of Care represents a shift toward a more comprehensive, patient-centered approach to wound healing. It ensures that all the critical aspects of wound management—biological, environmental, and patient specific factors such as mental health and social circumstances—are addressed.

T.I.M.E.R.S. complements Standard of Care by:

• Expanding the focus to include both biological and non-biological factors.
• Incorporating advanced therapies into the treatment plan.
• Emphasizing patient-centric care, ensuring that the wound healing process addresses individual patient needs.

T.I.M.E.R.S. – What Does It Stand for?

Journal of Wound Care’s International Consensus Document defines T.I.M.E.R.S. as a general framework to guide care at all competency levels in all settings. Although relevant to all care settings, the details of wound management would vary according to each setting and health professional competencies.

T.I.M.E.R.S. is an acronym that stands for:

• T: Tissue viability – Removing non-viable tissue (e.g., through debridement).
• I: Infection/Inflammation – Managing infection and inflammation that impede healing.
• M: Moisture balance – Ensuring the wound is maintained in an optimal moisture environment.
• E: Wound edge – Managing wound edges for proper epithelial migration.
• R: Regeneration/Repair – Promoting tissue regeneration and repair through advanced therapies.
• S: Social factors – Addressing social and patient-related factors, such as health literacy, mental health, and patient support.

Delving into Details of T.I.M.E.R.S.

By utilizing the T.I.M.E.R.S framework, clinicians can assess and manage hard-to-heal wounds in a way that is both structured and holistic. Here’s a deeper dive into each component:

1. T – Tissue Management

The first priority in wound care is to assess and remove devitalized tissue including defective matrix and cell debris through debridement. Nonviable tissue facilitates infection and impedes the healing process. Therefore, here the goal is to eliminate it. Proper tissue management clears the path for new tissue growth and infection control, laying the foundation for successful healing.

2. I – Inflammation and Infection

Chronic inflammation and infection is a major barrier to wound healing. As biofilm forms around bacteria in wound bed, it resists standard treatments, complicating infection management. Questions to consider include:

• Is there an infection in the wound or signs of sepsis?
• What types of organisms are present (bacteria, fungus, or biofilm)? Once the infection is identified, tailored treatments are essential. The timely management of inflammation and infection reduces wound complications and promotes healing.
• An agent that effectively disrupts the biofilm and can prevent it’s reformation is needed at this point.

3. M – Moisture Balance

Maintaining the right level of moisture in the wound bed is key to promoting healing. Wounds that are too dry can experience delayed healing, while excess moisture can lead to maceration and surrounding skin damage. The goal is to create a moist environment conducive to tissue repair. Dressings and wound care products are chosen based on the exudate levels, ensuring the wound remains in the optimal moisture balance.

4. E – Epithelial Edge

The wound edge often provides insight into the healing process. If the wound edges are rolled (epibole) or keratotic, it may prevent the epithelial cells from migrating across the wound, delaying closure. A key question is: What can be done to advance the wound edge? In some cases, wound edge excision or the use of advanced therapies like bioengineered skin or tissue grafts may be required to facilitate healing.

5. R – Regeneration and Repair of Tissue

Wound regeneration is the process of promoting tissue growth and repair. By addressing the wound’s underlying causes (such as infection, ischemia, or poor nutrition), clinicians can help optimize the healing environment. Interventions such as growth factors, stem cells, and oxygen therapies can stimulate regeneration, encourage collagen production, and promote tissue repair. It’s critical to assess the patient’s risk factors and provide therapies that will enhance tissue regeneration.

6. S – Social and Patient-Related Factors

In wound care, it’s not just about the biology of the wound but also the social and psychological aspects of the patient’s life. Non-clinical social- and patient-related factors that influence wound healing can be categorized into four main areas: psychosocial factors, adherence-related factors, physical and comorbidity factors, extrinsic factors. Patient education is essential to ensure compliance and understanding of the treatment plan. Clinicians should consider:

• Does the patient have cognitive impairments or depression?
• What is the patient’s health literacy and social support?
• Are there financial constraints or geographical challenges in accessing care? By recognizing these social factors, healthcare professionals can better tailor care plans, improving the likelihood of success and patient satisfaction.

Alignment of DEBRICHEM® with T.I.M.E.R.S. framework

DEBRICHEM® aligns perfectly with this framework, addressing critical aspects of wound management that are necessary for successful healing.

T – Tissue:

One of the most crucial components of wound bed preparation is debridement – removing non-viable and devitalized tissue containing biofilm and infection to ensure an optimal environment for healing.

DEBRICHEM® does this in 60 seconds through a targeted biochemical reaction with water in the biofilm, releasing an impressive amount of energy—approximately 1500 kJ/mol. This energy denatures and carbonizes the biofilm’s extracellular polymeric substance (EPS), breaking down its structure and destroying its contents. Over time, the denatured and carbonized material detaches from the wound surface. As it remains in place initially, granulation tissue begins to form underneath, creating the foundation for healing. By eliminating the biofilm barrier, DEBRICHEM® facilitates granulation and reopens the natural path to wound recovery.

I – Infection/Inflammation:

DEBRICHEM® also directly addresses the infection control component of T.I.M.E.R.S. As evidenced by imaging, DEBRICHEM® not only quickly removes bacteria from the wound bed but also facilitates an environment that prevents reformation of biofilm and thereby infection over time at follow-up visit. Unlike conventional methods that fail to remove the entire biofilm at once, research has shown that DEBRICHEM® removes up to 99,99% of bacteria in a single application, allowing the body’s immune response to prevent biofilm regrowth. This aligns with the Standard of Care guidelines that emphasize early infection control to prevent complications.

M – Moisture Balance:

DEBRICHEM® integrates well with the moisture management treatments like NPWT subsequent to debridement, that can maintain optimal moisture levels, addressing both excess moisture and dryness, thus promoting a balanced wound environment that supports healing.

E – Wound Edge:

The quality of the wound bed is key to epithelial advancement from the wound margins. By creating a clean, conducive to healing, wound environment DEBRICHEM® supports in optimizing the condition required for re-epithelialisation.

International Consensus Document on T.I.M.E.R.S mentions that “it is highly unlikely that epithelial advancement from the margins will occur if high levels of exudate production, the underlying pathology, biofilm, and infection have not been addressed.”

DEBRICHEM® addresses these causes and thereby paves the way for granulation and re-epithelialisation.

R – Regeneration/Repair:

A wound that is difficult to heal responds to cellular growth and tissue repair, once the underlying risk factors have been managed – biofilm and infection being the key factors. By eliminating biofilm, infection, necrotic tissue and preventing further infection, DEBRICHEM® creates the ideal conditions for repair and regeneration therapies like signal molecules or growth factors; oxygen therapy; or stem cells.

S – Social Factors:

With DEBRICHEM®, the overall wound care process becomes faster, delivering positive results in a shorter time, instilling confidence in patients and increasing the likelihood of consistent adherence to the prescribed regimen. As progress is visible in a shorter time frame, patients feel empowered, making it easier to address social and patient-related challenges. The rapid improvement also reduces the burden of prolonged treatments. This improves the overall patient experience, aligning clinical outcomes with their personal goals and enhancing the patient’s quality of life throughout the healing journey.

Conclusion

The integration of T.I.M.E.R.S. into the Standard of Care ensures a holistic and systematic approach to wound healing, improving outcomes for patients. As wound care continues to evolve, DEBRICHEM® offers a proven solution that aligns with the latest advancements in wound management, supporting the T.I.M.E.R.S. framework and enhancing the Standard of Care to achieve optimal healing results.

Request a demonstration: https://www.debx-medical.com/request-a-demonstration/

#WoundCare #Debridement #Biofilm #TissueViability #WoundHealing #InfectionControl #MoistureBalance #WoundManagement #PatientCare #HealthcareProfessionals #DEBRICHEM® #TIMERS

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Importance of Debridement: Why removing biofilm and necrotic tissue is critical for wound recovery.

Debridement Methods: Insights on traditional techniques (surgical, autolytic, enzymatic, etc.).

A chemical debridement method that completely eliminates biofilm in 60 seconds, promotes healing, and reduces costs.

Practical Resources: Links to further reading and opportunities for demonstration of advanced debridement solution.

Hard-to-Heal Wounds

Hard-to-heal wounds are those that do not progress toward healing within an expected timeframe. Often referred to as chronic, non-healing, or recalcitrant they are caused by a variety of factors, with research suggesting biofilm as the leading cause of their persistence.

Debridement – Effective Removal of Biofilm – is Key

Biofilm – microbes embedded in a protective layer – forms within 24 to 48 hours on wound surfaces after first contamination of the wound by microorganisms. Once established, it stalls the wound healing process, leads to infection, and can also cause sepsis if not removed timely.

This layer is particularly tough to break through, as it resists immune responses, antibiotics, and other antimicrobial therapies. It disrupts the wound healing process by constantly triggering inflammation, impeding cell migration, and promoting infection.

This is why it’s removal is a top priority for clinicians to restore conditions conducive to healing. They achieve this via Debridement – the medical process of removing dead, damaged, or infected tissue from a wound.

How Does Debridement Help?

Debridement essentially helps in promoting healing and preventing infection by clearing away any tissue that could hinder the body’s natural healing processes. While helping to reduce the microbial load, it stimulates the body’s healing response, and create a clean environment where new tissue can form, thus supporting the wound’s recovery. This cleansed wound allows clinicians to better assess the extent of the wound, including the depth, edges, and underlying structures, which is crucial for planning further treatment.

No debridement, no healing!

Before we dive into various debridement methods, let’s first understand the economic burden infected hard-to-heal wounds pose and therefore the importance of searching an ideal debridement method.

Economic Burden!

The cost of managing hard-to-heal wounds is substantial. A cohort study of 3.8 million patients treated for wounds by the NHS revealed that £5.6 billion of the NHS’s £8.3 billion annual wound care expenditure was spent on unhealed wounds.

Additionally, the cost of managing infected wounds varied significantly, with £2,000 for non-infected wounds and £5,000 to £11,200 for those with infection.

For pressure ulcers, the 12-month average cost varied significantly by severity, with category 1 ulcers costing £1,400 to manage, compared to over £8,500 for more severe categories. Unhealed pressure ulcers had an average management cost of £12,300, more than twice the £5,140 required for healed ulcers.

What Would Be An Ideal Debridement Method?

While there are many ways to debride a wound, the costs of repetitive procedures, delayed healing, and frequent hospital visits underscore the need for more effective, accessible debridement options. An ideal option would:

Quickly & easily eliminate biofilm, infection, & necrotic tissue.

Promote granulation & help get rid of inflammation.

Restart the wound healing process & prevent repetitive procedures.

Reduce risk of re-infection & re-formation of biofilm.

Decrease pain & prevent complications.

Improve patients’ quality of life.

Be clinically & cost-effective.

Be available at point of need for the patient.

Can be implemented in any setting, hospital or community.

Debridement Types

Surgical Debridement

Surgical debridement involves using surgical instruments to remove devitalized tissue, typically under anesthesia. This method may not be suitable for all patients, especially those with comorbidities, and is costly due to the need for hospital admission. Surgical debridement is typically reserved for special cases, such as abscesses, and may need to be repeated.

Key Considerations:

• Requires specialized skills and equipment
• Often performed hospital setting (Operation Room).
• Anesthesia and hospital admission carry risks such as infection, mobility issues, and complications like blood loss or nerve damage.
• The procedure may need to be repeated several times, and patients may be unwilling to undergo it due to its invasive nature.

Sharp Debridement

Sharp debridement uses tools like scissors, scalpels, or a curette to debride non-viable tissue and manage biofilm. This technique can be performed in various settings, but it demands specialized training to avoid complications, such as accidental injury to healthy tissue.

Key Considerations:

• Requires significant skill and training which means it is not always readily available at patients’ point of need.
• Contraindicated in very large wounds, patients being treated with anticoagulants or with a raised risk of bleeding.
• Comes with the risk of damage to blood vessels, nerves, and tendon.
• Not always effective in addressing biofilm, which may persist in the wound bed after debridement.

Autolytic Debridement

This approach relies on hydrogel, hydrocolloid, or hydrofiber dressings that maintain a moist environment, allowing the body’s natural processes to break down dead tissue. While less invasive and easy to use, it can be slow and does not effectively target biofilm.

Key Considerations:

• Slow process, requiring days or even weeks to achieve effective debridement.
• Carries the risk of invasive infection and wound-edge maceration.
• Less effective in removing biofilm, which can persist and slow down healing.
• May not be suitable for heavily contaminated or infected wounds.

Hydrosurgical & Ultrasonic Debridement

Hydrosurgical method uses high-pressure application of a liquid such as water, saline, polyhexanide, etc while ultrasonic debridement uses direct or indirect application of low-frequency energy.

Key Considerations for Both:

• Requires specialist equipment and professional training.
• Has the potential to disseminate bacteria into the environment due to aerosolisation.
• Limited effectiveness against biofilm.
• Expensive and not suitable in all settings.

Biological Debridement

Biological or larval debridement uses larvae of the green bottlefly to ingest devitalised tissue and microbes. The larvae are administered loose or in a biobag.

Key Considerations

• Costly and patients find it physically uncomfortable.
• It is psychologically off-putting for patients.
• Not suitable for very dry wounds or very wet wounds.
• Not suitable for wounds with exposed blood vessels, malignant wounds or patients with decreased perfusion.

Mechanical Debridement

Mechanical debridement involves use of monofilament cloths, pads, or wipes to remove slough and devitalized tissue from the wound bed.

Key Considerations

• Not used for management of necrotic tissue.
• Slow Method.
• Not suitable for dry eschar.

Enzymatic Debridement

This method also called biochemical debridement is implemented using topical application of enzymes. These agents have a specific action based on the enzyme used and the protein it breaks down.

Key Considerations

• Relatively expensive.
• Not recommended for large and infected wounds.
• Has been shown to work slowly.

Chemical Debridement with DEBRICHEM®: A Targeted Approach

Chemical debridement with DEBRICHEM® works through a targeted biochemical reaction with water in the biofilm, releasing an impressive amount of energy—approximately 1500 kJ/mol. This energy denatures and carbonizes the biofilm’s extracellular polymeric substance (EPS), breaking down its structure and destroying its contents. Over time, the denatured and carbonized material detaches from the wound surface. As it remains in place initially, granulation tissue begins to form underneath, creating the foundation for healing. By eliminating the biofilm barrier, DEBRICHEM® facilitates granulation and reopens the natural path to wound recovery.

Broad Spectrum Nature & Integration with Advanced Therapies

DEBRICHEM® is suitable for a wide range of non-surgical infected wounds, including challenging, end-stage cases. It works as an adjuvant tool that supports a range of advanced wound care therapies by making the wound bed more responsive to these therapies. After its application, treatments like Negative Pressure Wound Therapy (NPWT) can be used more effectively, as the wound bed is now primed for better healing responses. This makes DEBRICHEM® a versatile and valuable tool in wound management, enhancing the overall effectiveness of subsequent treatments and reducing the need for repeated visits or specialized equipment.

Key Considerations

Eradication of Biofilm + Infection & Preventing Its Reformation

DEBRICHEM® completely eliminates biofilm and enables the body’s immune system to prevent it from returning.

Immediate Results with a Single Application

DEBRICHEM® delivers rapid results in just 60 seconds, often requiring only one application.

Promotion of Granulation & Decreased Pain

By facilitating a clean wound environment, DEBRICHEM® reopens the pathway to healing and reduces inflammation and pain.

Prevention of Complications

By effectively removing necrotic tissue and biofilm, DEBRICHEM® helps prevent further complications.

Cost-Effective Treatment

With fewer visits and no need for specialized equipment, DEBRICHEM® offers significant cost savings.

Generates Results without Specialized Expertise

As a topical agent, DEBRICHEM® is easy to apply and requires no specialized training, making it accessible to a wide range of healthcare professionals.

Supporting Evidence and Real-World Results

Studies have shown that DEBRICHEM® improves health-related quality of life for patients and reduces overall treatment costs. A UK cost-effectiveness study found that DEBRICHEM® improved healing rates by up to 75%, reduced infection risks, and significantly cut overall treatment costs by up to 57%. In real-world clinical settings, case studies have time and again demonstrated rapid and biofilm eradication with DEBRICHEM® application, facilitating faster wound healing and improving patient comfort.

Effective Debridement: Future of Wound Care

The role of debridement in managing biofilm cannot be overstated in addressing the growing global challenge of hard-to-heal wounds. By ensuring a clean, well-prepared wound bed, debridement facilitates faster healing and reduces the risk of complications like infection and sepsis. Debridement helps break the cycle of biofilm formation and enhances the effectiveness of subsequent therapies. As new method like DEBRICHEM® become more widely available, healthcare providers are having better tools to manage biofilm, reduce chronicity, and ultimately improve patient outcomes.

By choosing the right debridement technique and adopting a structured approach to wound-bed preparation, clinicians can make significant strides in accelerating healing and reducing the impact of chronic wounds on patients and healthcare systems alike.

Delve Deeper

Dive deeper into effective debridement strategies in the article: Comparing Methods of Debridement for Removing Biofilm in Hard-to-Heal Wounds by Karen Ousey and Liz Ovens. Download the article for free here: https://www.debx-medical.com/scientific-papers/.

Additionally, experience the benefits of DEBRICHEM® firsthand! Request a free debridement demonstration here: https://www.debx-medical.com/request-a-demonstration/

The post Different Methods of Debridement: An Overview appeared first on Innovating The Future of Wound Care.

Complete granulation achieved in 13.2 days on average for ulcers that persisted for on average 13 months (3-48 months).

This result comes from a study that combined DEBRICHEM®, a chemical debridement agent, with NPWT (Negative Pressure Wound Therapy) to tackle challenging hard-to-heal leg and foot ulcers. The study’s success stems from combining two evidence based premises. First, the evidence that DEBRICHEM® effectively removes bio burden from a wound in seconds, a primary barrier preventing granulation in stalled wounds. Second, that once the wound is debrided and biofilm is removed, NPWT supports the wound healing cascade.

The Synergistic Approach

The study demonstrated that the synergy between DEBRICHEM® and NPWT accelerated granulation. With a straightforward protocol involving a 60-second DEBRICHEM® application, the treatment created an ideal environment for NPWT to operate effectively, leading to the following results:

Complete granulation in an average of 13.2 days (7-21 days) with a single application of DEBRICHEM® and one week of NPWT, followed by vaseline gauze treatment.

Rapid removal of biofilm and soft necrosis from large lesions of various etiologies, promoting a healthy wound bed and facilitating granulation tissue formation.

Effective even in elderly patients with serious comorbidities and medications that negatively impact wound healing, with no significant adverse events.

Cost-saving benefits from fewer treatment visits and dressing changes, and simplified debridement procedures that can be performed in a basic medical setting without advanced expertise.

No need for antibiotics, as the treatment proved effective without their use.

Before diving into the study’s methodology and model, let’s first examine the burden this solution addresses.

Cycle of Stagnation: A Microbial, Medical, & Financial Burden

Microbial Burden

Biofilms plague chronic leg and foot ulcers. These are microbial communities that are known for resistance to treatments and immune responses. Combined with necrosis, biofilms trap ulcers in a chronic state, preventing progress, sometimes even after treatment. This cycle of stagnation, characterized by recurring biofilm formation, delays healing and perpetuates the chronic nature of these wounds and their burden.

Medical & Financial Burden

Non-healing wounds are not only a medical challenge but also a financial burden.

In the US alone:

• 8% of diabetic Medicare patients develop foot ulcers, leading to annual treatment costs of $9–13 billion.
• Venous leg ulcers, affecting 1% of the population, add an average of $6,391 per patient annually in Medicare expenses.

In the UK:

• Managing VLUs costs an average of £7,706 per patient, contributing to an annual healthcare system cost exceeding £2 billion.

The Study

The study that forms the basis of this article, titled “Combining an Acidic Compound and NPWT: Debridement and Granulation in Leg and Foot Ulcers,” was led by Dr. Michel H.E. Hermans. The study aimed to evaluate the effectiveness of combining TDA: DEBRICHEM® and NPWT in treating chronic leg and foot ulcers, with a focus on removing biofilm and necrosis and promoting granulation tissue formation.

Ethical Approval

The study was approved by the ethical committee of the Villa Berica Hospital in Vicenza (Italy), in line with the declaration of Helsinki.

Why DEBRICHEM®?

DEBRICHEM® is an innovative addition to the tool box of wound care professionals. It is quick and effective, yet doesn’t require specialized expertise and sterile environments. DEBRICHEM® removes biofilm and infection in a single, 60 seconds application.

Advantages:

Immediate action, with effective removal of biofilm and soft necrosis you stop the host’s inflammatory immune response.

No need for specialized expertise or sterile settings, making it more accessible.

Fits seamless into treatment protocols.

Reduction of the peri-lesional redness is often visible immediately after DEBRICHEM® application.

How DEBRICHEM® Works?

DEBRICHEM® works through a targeted biochemical reaction with water in the biofilm, releasing an impressive amount of energy – approximately 1500 kJ/mol. This energy denatures and carbonizes the biofilm’s extracellular polymeric substance (EPS), breaking down its structure and destroying its contents. Over time, the denatured and carbonized material detaches from the wound surface. As it remains in place initially, granulation tissue begins to form underneath, creating the foundation for healing. By eliminating the biofilm barrier, DEBRICHEM® facilitates granulation and reopens the natural path to wound recovery.

Why NPWT?

Negative Pressure Wound Therapy (NPWT) involves the application of sub-atmospheric pressure to the wound bed through a sealed dressing, promoting healing through:

• Removing exudate and reducing edema.
• Improved perfusion and oxygenation.
• Micro- and macro-deformation effects that stimulate the wound healing cascade.
• Promotion of angiogenesis and granulation tissue formation.

Rationale for Combining DEBRICHEM® and NPWT

Enhanced Debridement

DEBRICHEM® boosts the effectiveness of NPWT by facilitating efficient debridement and infection control. It effectively removes soft necrotic tissue and biofilm, creating a clean wound bed that allows NPWT to function at its full potential.

Infection Control

By targeting and removing biofilm, DEBRICHEM® significantly lowers infection risks. This enables NPWT to focus on accelerating the healing process without complications caused by bacterial presence.

Promotes Easy Removal of Devitalized Tissue

By desiccating devitalized tissue into an inert structure with minimal bacterial load, DEBRICHEM® allows these remnants to be easily removed through negative pressure. This process reduces infection risks by lowering biofilm presence, enabling NPWT to focus on promoting healing through mechanical support and tissue regeneration.

Wound presented at clinic. Diabetic female patient. Post-traumatic ulcer that got chronically infected. Present for more than 2 years.

Day 0, immediate after DEBRICHEM® application

Day 3, partial detachment of the desiccated material with some granulation tissue. Day 7, complete detachment of the desiccated material with full granulation.

Study Model: Combining DEBRICHEM® and NPWT

Study Overview:

• Study Type: Prospective study
• Treatment Tested: Combination of DEBRICHEM® and NPWT
• Participants: 12 patients with a variety of ulcer types (venous, arterial, post-trauma)
• Average Size of Lesions: 308 cm²
• Duration of Ulcers: An average of 13 months (ranging from 4 to 48 months)

Study Protocol:

The protocol was designed to simplify the wound care process while maximizing its effectiveness. Instead of opting for invasive surgical procedures, patients were treated with DEBRICHEM® for debridement, followed by NPWT to support the wound healing process.

Inclusion Criteria:

• Ulcers that had not responded to treatment for at least four weeks.
• Clinically infected ulcers (confirmed by wound cultures).
• Patients aged 18 years or older.

Exclusion Criteria:

• Pregnant patients.
• Patients with ischemic legs without revascularization.
• Patients with osteomyelitis under the ulcer or exposed cartilage.

The Treatment Protocol:

The wounds were initially cleaned with saline, followed by peripheral nerve block in 7, spinal block in 4, lidocaine in 1. DEBRICHEM® was applied to the ulcer and 1 cm onto the surrounding skin. After 60 seconds, the DEBRICHEM® was diluted and removed with saline or water, leaving a clean wound bed. NPWT was applied using standard foam and negative pressure of -125 mm Hg. Dressings were changed every 2–4 days, with NPWT discontinued after seven days.

The Evidence: Rapid Granulation and Effective Debridement

The results were impressive. All 12 patients reached complete granulation within an average of 13.2 days, with the fastest granulation occurring in just 7 days and the slowest in 21 days. The study demonstrated that this combination therapy was not only effective but also safe, with minimal adverse events reported.

Key Insights:

• Diverse Patient Group: Rapid granulation was achieved across patients with a wide range of wound types and comorbidities, showing the broad applicability of DEBRICHEM® and NPWT in treating complex ulcers.
• Synergistic Action: The combination therapy delivered effective debridement, infection control, and tissue regeneration in a single treatment cycle.
• Adaptability:The study highlights that this combination can be used effectively across multiple types of ulcers, such as venous leg ulcers, arterial ulcers, and post-trauma wounds.
• Cost-Effective: By reducing the need for frequent dressing changes and avoiding systemic antibiotics, this treatment approach lowers overall healthcare costs.
• Improved Patient Experience: Patients benefited from reduced pain, quicker recovery times, and the potential for earlier discharge from care.

The Potential for Cost Reduction

One of the key benefits of this treatment approach is its potential to reduce healthcare costs. By accelerating granulation, this therapy reduces the number of visits and dressings, lowering treatment costs. Additionally, TDA can be applied without advanced surgical skills, making it suitable for a broader range of settings.

The Clinical Impact and Benefits

For healthcare professionals, integrating DEBRICHEM® with NPWT into standard treatment protocols for chronic ulcers can offer several benefits:

1. Faster Recovery: The combination of DEBRICHEM® and NPWT accelerates the healing process, allowing patients to return to their normal activities more quickly.
2. Reduced Pain: The effective debridement process minimizes discomfort for patients during treatment.
3. Improved Outcomes: Healthcare professionals can achieve better outcomes with less effort, increasing professional satisfaction.
4. Cost-Effectiveness: Shorter healing times lead to fewer patient visits and lower treatment costs, making the approach more affordable for both healthcare providers and patients.

Hospitals and clinics also benefit from:

• Reduced Infection Rates: Lower infection rates reduce the need for systemic antibiotics and the risk of hospital-acquired infections.
• Resource Optimization: By reducing the need for invasive procedures and frequent dressing changes, healthcare providers can allocate resources more efficiently.
• Enhanced Reputation: Delivering high-quality, effective care improves the reputation of healthcare institutions.

Learn More About DEBRICHEM® and Its Impact

At DEBx Medical, we are proud to contribute to wound care innovation. The combination of DEBRICHEM® and NPWT is a significant advancement in treating chronic ulcers, improving patient outcomes and reducing costs.

Request a free demonstration at your own clinic: https://www.debx-medical.com/request-a-demonstration/

#WoundHealing #ChronicUlcers #HealthcareInnovation #Debridement #Granulation #NPWT #DEBRICHEM #DEBxMedical

The post Combining an Acidic Compound and NPWT: Debridement and Granulation in Leg and Foot Ulcers appeared first on Innovating The Future of Wound Care.

Despite undergoing various treatments such as NPWT, fish skin application, hyperbaric oxygen therapy, and split skin grafts, no approach yielded satisfactory results. Frequent, painful dressing changes added to the burden, severely affecting the patient’s quality of life.

The goal of treatment was to find a solution to stabilize the wound, create a dry wound surface, and eliminate the pain associated with dressing changes, ultimately improving the patient’s overall quality of life outside the hospital setting. In response, DEBRICHEM® was introduced into his treatment plan. Owing to its versatility, DEBRICHEM® worked on this end stage case, as well as it works on other broad spectrum of wounds. It helped meet the clinicians’ goals for this case and resulted in:

Stabilized wound with dry and clean tissue

Successful patient discharge and home-based care

Prevention of further deterioration and hospital re-admissions

Reduced risk of complications

Reduced need for hospital based interventions

What It Meant for the Clinicians and the Patient?

For the clinician, this successful management of a case that had previously defied all conventional treatment approaches, represented a significant step forward. The successful stabilization of the wound offered a tangible solution to reducing the risks associated with prolonged infection and sepsis.

For the patient, the application of DEBRICHEM® brought relief from the constant pain associated with wound dressing changes and provided a viable pathway for managing the wound at home, thus improving their overall quality of life and reducing hospital dependence.

Broad-Spectrum DEBRICHEM®

This case is a testament to the broad-spectrum action of DEBRICHEM® in removing biofilm and infection. Even in end-stage cases like this it helps improve the quality of patients’ remaining life time by making the wound more manageable. This manageability is a result of benefits that usage of DEBRICHEM® brings along like removal of infection and inflammatory response, decreased pain, prevention of complications, reduced risk of re-infection, and promoting granulation.

Guideline Followed to Report the Case

This case was published in International Journal of Surgery Case Reports in alignment with the consensus-based surgical case reporting guideline (SCARE guidelines). These guidelines ensure the comprehensive documentation and ethical reporting of complex surgical cases, providing clarity on the methodology and the results of the treatment approach. The publication is originally titled Innovative Biochemisurgical Treatment for Stabilisation of an End-Stage Chronic Wound in a Complex Vascular Compromized Patient. You can access it for free via a link provided at the end of this article.

Case in Detail

Patient Background:

Patient was a 55-year-old male with a complex medical history that included vascular compromise and diabetes mellitus. He had been a smoker for over 30 years, and his condition was classified as ASA III by the American Society of Anesthesiologists, indicating moderate to severe systemic disease, complicating his case further.

The patient had already undergone multiple operations, including an above-the-knee amputation of the left leg at another hospital, and used a prosthesis for mobility.

He arrived at Euregio outpatient clinic after a delay in seeking medical attention, which had allowed his condition to worsen significantly. Upon presentation, he exhibited signs of pre-sepsis. His case was further complicated by advanced Peripheral Arterial Occlusive Disease (PAOD), classified as Fontaine Class IV, indicating the most severe form of arterial blockage that significantly impairs blood flow to the extremities.

Wound at Presentation

The primary concern for coming to the hospital was blistering and ulceration on the stump area of the left leg, probably caused by non-proportionate pressure from his prosthesis. This pressure has been a well-known risk factor for developing non-healing ulcers, which are notoriously difficult to treat. The patient’s wound was not only infected but also failed to heal after months of treatments.

Medical and Surgical Challenges

Medical team conducted biopsy, including wound cultures and a medical microbiological consultation. This testing made it clear that surgical debridement and antibiotic treatment were needed. The patient was therefore started on Pipracilline/Tazobactam, an antibiotic combination.

But no surgical options could be implemented as patients’ PAOD posed a major barrier. Revascularization, a procedure designed to restore blood flow to the affected areas, was unfortunately unfeasible for the patient. The arteries in the left iliac axis and groin were completely occluded, leaving no viable pathways for re-establishing blood flow. All major arteries were closed, and blood flow was only maintained by collateral circulation, a less efficient route. With no landing zone available for revascularization, no further surgical options could be pursued.

In addition to this the advanced stage of PAOD significantly impacted the wound’s healing capacity and made conventional therapies less effective.

Biofilm and Necrosis: Persistent Barriers

Chronicity of this case was also a result of the persistence of infection and particularly biofilm: cluster of microbes protected by extracellular polymeric substances (EPS). Biofilms are highly resistant to antibiotics and antiseptics, as well as to the body’s own defense mechanisms, making them difficult to treat with conventional therapies. They create a hyper-inflammatory environment, impeding the healing process by promoting prolonged inflammation.

Similarly, necrosis, which contains dead tissue and microorganisms, further hampers the healing process by complicating tissue regeneration. For successful management of the, both biofilms and necrosis needed to be effectively addressed, with rigorous debridement being the conventional method to remove these impediments.

Treatments Tried

This patient’s treatment journey began when he was admitted to the hospital for a wound infection and underwent re-amputation with diagnostic subtraction angiography. Over the course of following year, the patient faced multiple re-admissions and various treatments, including,

• Vacuum therapy (NPWT), which uses negative pressure to promote healing
• Grupss therapy (which was not effective in this case)
• Fish skin application as a bioactive dressing
• Platelet enriched plasma-therapy
• Split-skin grafting, to cover the wound with healthy skin
• Hyperbaric oxygen therapy in specialized clinics in Münster and Düsseldorf

Despite these interventions, the wound persisted as a chronic, non-healing ulcer. Each attempt was unsatisfactory and nothing succeeded in any form, leading to frustration for both the patient and the medical team.

What Did the Clinicians Want to Achieve for this Case?

The primary goal of the clinicians was to stabilize the wound by getting rid of biofilm and infection, create a dry and clean wound bed, and provide a pathway for home-based care.

A more manageable wound. Given the complexities of the patient’s condition and the failure of previous treatments, the goal was not only to stop the progression of infection and sepsis but also to provide the patient with a more manageable wound.

Reduction of associated pain. One of the main challenges was the intense pain caused by the daily changes of regular wound dressings, which were distressing for the patient. So, the clinicians aimed to transition the wound into a stable, dry surface, so that the pain associated with dressing changes can be eliminated.

Minimize the need for frequent hospital visits. This approach was intended to minimize the need for frequent hospital visits, improve the patient’s quality of life outside the hospital and allow for the wound to be managed at home.

Inclusion of DEBRICHEM® in the Treatment Process

After several months of unsuccessful treatments, DEBRICHEM® was introduced into the patient’s care plan. Initially, it was used alongside Vacuum Therapy, followed by 2 additional applications of DEBRICHEM®, one each month, without Vacuum Therapy.

The treatment protocol followed the Instructions for Use (IFU) provided for DEBRICHEM®, which stipulated that the agent should be applied for a duration of up to 1 minute. Below is the step-by-step treatment protocol that was used:

1. Initial Preparation:The wound and surrounding periwound skin were cleaned. This step is essential to prepare the wound for optimal agent application.
2. Application of DEBRICHEM®:TDA was carefully applied directly to the lesion, extending about 1 cm beyond the wound margin. The agent was left for exactly 60 seconds, as per the protocol outlined in the IFU.
3. Post-application Procedure:After the 1-minute application period, the TDA was diluted and removed by gently rinsing the area with sterile water or saline.
4. Pain Management:To minimize discomfort, the wound bed was pretreated with appropriate anesthesia, and the procedure was carried out under general anesthesia in this case.
5. ASA Classification Consideration:The patient’s ASA Class III status, indicating moderate to severe systemic disease, emphasized the need for a tailored, careful approach to the treatment. Each step was meticulously planned and executed to mitigate any additional risks, considering the patient’s overall health and medical history.

DEBRICHEM® Dealt with Persisting Biofilm & Infection: How Did it Work?

DEBRICHEM® debrides through a targeted biochemical reaction with water in the biofilm, releasing an impressive amount of energy—approximately 1500 kJ/mol. This energy denatures and carbonizes the biofilm’s extracellular polymeric substance (EPS), breaking down its structure and destroying its contents. Over time, the denatured and carbonized material detaches from the wound surface. As it remains in place initially, granulation tissue begins to form underneath, creating the foundation for healing. By eliminating the biofilm barrier, DEBRICHEM® facilitates granulation and reopens the natural path to wound recovery.

What Was Achieved?

The rapid desiccation properties of DEBRICHEM® effectively eliminated biofilm and necrotic tissue. The desiccation effect was virtually immediate, causing tissues to denature, coagulate, and separate from the underlying surface.

This resulted in:

Stable Wound Environment. The creation of a stable wound environment, characterized by dry and clean wound tissue, reducing the burden of infections.

Reduction in Pain. This transformation allowed the wound to be managed with significant reduction in pain associated with daily dressing changes.

Home-Based Care & Reduced Risk of Complications. By fostering the growth of clean, dry necrotic tissue, the wound became more manageable, even in the patient’s home setting, facilitating easier care and reducing the risk of further complications.

Improved Quality of Life. The result helped improve the patient’s quality of life outside hospital and reduced the need for frequent hospital-based interventions.

The Role of Multidisciplinary Care

This case also underscores the importance of a multidisciplinary approach in managing complex poorly healing wound cases. In the treatment strategy at Euregio Hospital, wound specialists, nurses, microbiologists, vascular and endovascular surgeons, anesthesiologists, medical prosthetic experts, and rehabilitation experts ensured comprehensive care tailored to the patient’s unique needs. The collaboration of these specialists was essential in achieving a successful outcome and improving the patient’s overall health and quality of life.

Next Steps for Wound Management

For clinicians seeking interventions for poorly healing wounds’ management, DEBRICHEM® offers a promising option. If you’re dealing with end stage complex wound cases, consider exploring how DEBRICHEM® can help stabilize them, reduce infection risks, and improve patient outcomes.

Request a demonstration at your clinic: Request a Demonstration – Innovating The Future of Wound Care

Download the full publication here: https://www.debx-medical.com/scientific-papers/

#ChronicWoundCare #WoundHealing #VascularCompromise #NonHealingWounds #DEBRICHEM #WoundManagement #InnovativeWoundTreatment

The post Stabilization of an End-Stage Wound in a Vascular Compromised Amputated Case appeared first on Innovating The Future of Wound Care.

75% increase in the probability of healing with DEBRICHEM® plus standard of care (SC) compared to SC alone.

57% reduction in wound management costs, reducing 12-month treatment costs from £7195 per patient to £3128 with DEBRICHEM®.

Health-related quality of life improved from 0.74 to 0.84 QALYs (Quality Adjusted Life Years) per patient.

Sensitivity analysis confirmed cost-effectiveness under multiple scenarios, with DEBRICHEM® plus Standard of Care remaining a dominant treatment under realistic cost and effectiveness variations.

59% reduction in nursing and healthcare assistant visits along with >90% reduction in hospital admissions.

These results suggest that adding DEBRICHEM® to standard of care offers not only clinical effectiveness but also substantial cost savings. But how did researchers arrive at these findings, and what makes this study so significant?

Purpose of This Study

Venous leg ulcers (VLUs) are a leading cause of morbidity and significantly reduce health-related quality of life (HRQoL), particularly among older populations. In the UK alone, the prevalence of VLUs in adults aged 18 and older is estimated to be approximately 1 VLU per 100 individuals, highlighting the widespread nature of this condition.

Many VLUs become hard-to-heal due to biofilm and persistent infection. These biofilms, which are clusters of bacteria encased in a protective matrix, protect pathogens from both the body’s immune system and antimicrobial treatments, severely delaying the healing process. Hard-to-heal VLUs can take months, or even years, to heal and are prone to recurrence, creating a substantial ongoing burden on both patients and healthcare systems.

Cost Burden

The economic impact of VLUs is staggering. In 2017/18, the NHS spent an estimated £3.20 billion annually managing VLUs, with 87% of this cost (£2.78 billion) attributed to hard-to-heal ulcers.

Challenges of Debridement

Debridement is essential in wound care to remove dead tissue, cellular debris, and biofilms, which impede healing progress. Without debridement, biofilm and dead tissue can lead to persistent infections, delayed healing, and even ulcer recurrence.

However, debridement comes with significant challenges:

• It is an intensive and time-consuming process that needs to be repeated multiple times, which adds to the overall treatment duration.
• In clinical settings, it requires specialized tools and highly trained professionals, contributing to increased costs.
• In community settings—such as at-home care or local clinics—debridement becomes even more difficult due to limited resources, lack of proper tools, and the absence of specialized personnel.
• The spatial distribution of biofilms further complicates their removal, requiring a more targeted and precise approach.

DEBRICHEM® Counters Challenges of Debridement & Costs

DEBRICHEM® debrides through a targeted biochemical reaction with water in the biofilm, releasing an impressive amount of energy—approximately 1500 kJ/mol. This energy denatures and carbonizes the biofilm’s extracellular polymeric substance (EPS), breaking down its structure and destroying its contents. Over time, the denatured and carbonized material detaches from the wound surface. As it remains in place initially, granulation tissue begins to form underneath, creating the foundation for healing. By eliminating the biofilm barrier, DEBRICHEM® facilitates granulation and reopens the natural path to wound recovery.

Clinically Effective & Overall Cost Reducing Solution

Multiple clinical studies have already demonstrated the effectiveness of DEBRICHEM®. Key findings from these clinical studies include:

• Saves Time: DEBRICHEM® works within 60 seconds, delivering a fast and effective solution for non-selectively eradicating biofilm, soft necrosis, and infection. This rapid action streamlines wound care processes and reduces the time clinicians spend on each patient.
• High Success Rate: Over 90% of cases show complete granulation after a single application, reducing the need for repeated debridements.
• Minimal Impact on Healthy Tissue: Unlike other methods, DEBRICHEM® specifically targets the biofilm and pathogens, leaving the surrounding healthy tissue unaffected. This precision ensures effective treatment without damaging surrounding skin.
• No Need for Antibiotics: DEBRICHEM® is effective without the need for antibiotics, making it a valuable alternative in preventing resistance and reducing the need for systemic medications.
• Improved Healing Outcomes: Clinicians have reported better patient outcomes when DEBRICHEM® is included in treatment protocols.
• Multiple Setting Use: Thanks to its ease of use, DEBRICHEM® can be used in clinics and community settings, making it accessible for a wide range of healthcare environments.

By reducing treatment time and the need for additional resources, DEBRICHEM® helps drive down healthcare costs. DEBRICHEM®’s effectiveness in tackling biofilm and infection reduces the need for prolonged care, hospital admissions, and repeated treatments, leading to significant cost savings for healthcare systems.

Significance of This Study

The significance of this study lies in DEBRICHEM® having the potential to not only improve patient outcomes but also provide a cost-effective treatment option to health institutions, which are under increasing pressure due to rising healthcare demands and limited resources. By improving the healing rate and reducing the overall cost of treatment, DEBRICHEM® could help mitigate the burden of hard-to-heal wounds on the healthcare system.

What did the Study Assess?

The study assessed whether DEBRICHEM® could provide a cost-effective solution for managing hard-to-heal venous leg ulcers (VLUs) within the UK’s National Health Service (NHS). The study estimated how cost-effective DEBRICHEM® plus Standard of Care is by calculating the extra cost for each additional year of healthy life it provides, by calculating the incremental cost per quality-adjusted life year (QALY) gained.

Model of the Study

To do this, researchers constructed a Markov model. The model depicted the management of hard-to-heal VLUs over 12 months and compared two treatment strategies:

• DEBRICHEM® plus standard of care (SC)
• SC alone

This Markov model was based on an indirect comparison of two propensity score-matched cohorts: one treated with DEBRICHEM® plus Standard of Care, and the other treated with Standard of Care alone. Patients were matched based on age, sex, wound duration, and comorbidities, ensuring the comparison was as unbiased as possible.

The cost-effectiveness of DEBRICHEM® was assessed by evaluating the incremental cost per quality-adjusted life year (QALY) gained. The study also conducted various sensitivity analyses to ensure the robustness of the results under different clinical scenarios.

Model Population

The model was populated using a combination of:

• Transition probabilities: Likelihood of the ulcer moving between health states: infected, remaining static, and improved (or healed). Clinical outcomes: Results from treatment interventions.Resource utilisation estimates: Healthcare resources used in managing Venous Leg Ulcers. Each health state in the model was populated with relevant resource use estimates.Utilities: Measures of patient quality of life associated with each health state.

Model Outputs:

• Primary Measure of Effectiveness: Patients’ Health Related Quality of Life in terms of the number of Quality Adjusted Life Year at 12 months from the time patients entered the model.
• Secondary Measure of Effectiveness: The probability of healing by 12 months from the time patients entered the model.
• Cost Estimation: The expected NHS cost of patient management over 12 months from the time patients entered the model was estimated at 2019/20 prices.
• Cost Effectiveness: The potential cost-effectiveness of adding DEBRICHEM® to a Standard of Care protocol compared to Standard Care alone was calculated using the following formula:

Incremental cost per Quality Adusted Life Year gained = (Difference in expected costs between the two treatment strategies) / (Difference in the number of Quality Adjusted Life Years between the two treatment strategies).

• If one strategy produced more Quality Adjusted Life Years for a lower cost, it was considered the dominant intervention.
• Probabilistic sensitivity analysis: The analysis helped estimate the probability of DEBRICHEM® plus Standard of Care being cost-effective compared to Standard of Care alone at various cost per Quality Adjusted Life Year thresholds.
• Deterministic sensitivity analysis was conducted to assess the impact of varying individual parameters within the model.
• Budget impact analysis was conducted to assess the resource implications and financial impact of incorporating DEBRICHEM® into treatment protocols.

Results of the Study

Clinical Outcomes and Healthcare Costs

Healing Probability:

• DEBRICHEM®-treated patients had a 0.61 healing probability after 12 months.
• Standard of Care-treated patients had a 0.35 healing probability after 12 months.
• This represents a 75% increase in healing probability with DEBRICHEM®.

Health-Related Quality of Life (HRQoL):

• DEBRICHEM®-treated patients showed a 0.1 Quality Adjusted Life Year improvement over those treated with Standard of Care alone, indicating improved quality of life for patients receiving DEBRICHEM®.
  

Cost of Treatment:

• The cost for DEBRICHEM® plus Standard of Care treatment was £3128 per patient over 12 months.
• The cost for Standard of Care alone treatment was £7195 per patient.
• This represents a cost-saving of £4,067, while improving Quality Adjusted Life Years by 0.10.
  
  

Including DEBRICHEM® in a Standard of Care protocol could potentially offer the NHS a dominant treatment, as it improves outcomes at a lower cost.

Probabilistic Sensitivity Analysis

This analysis showed how costs and quality of life (QALYs) were distributed over 12 months for both treatment options.

At a cost-effectiveness threshold of £20,000 per QALY, up to 96% of patients were expected to benefit more cost-effectively from DEBRICHEM® plus Standard of Care (SC) compared to SC alone.

Deterministic Sensitivity Analysis

Even when key parameters such as healing probability, nurse visits, and DEBRICHEM® costs were altered by 20% above and below base case values and utility scores by up to 10%, DEBRICHEM® remained a dominant treatment, with cost-effectiveness remaining <£20,000 per Quality Adjusted Life Year, confirming DEBRICHEM® plus Standard of Care as a cost-effective technology.

Budget Impact Analysis

The budget impact analysis revealed that treating hard-to-heal VLUs with DEBRICHEM® plus Standard of Care could lead to:

75% improvement in healing.

A 59% reduction in nursing visits, which would significantly decrease the burden on healthcare resources.

>90% reduction in accident and emergency attendances.

>90% reduction in hospital admissions.

A 57% reduction in total NHS wound management costs, saving £9.58 million.

This analysis suggests that including DEBRICHEM® in an Standard of Care protocol for hard-to-heal VLUs could:

Decrease the annual prevalence of these wounds at no additional cost.

Help reduce the health economic burden of wounds.

If the model’s time horizon was extended beyond 12 months, DEBRICHEM® would likely become more cost-effective, as there would be more unhealed wounds in the Standard of Care group at 12 months.

Future Implications for Healthcare Systems

The findings from this study are a critical step toward validating the clinical and economic benefits of DEBRICHEM® in the management of hard-to-heal Venous Leg Ulcers. As the healthcare system faces increasing pressures, DEBRICHEM® with its ability to improve healing rates, reduce healthcare costs, and alleviate the burden on healthcare resources is a valuable addition to the toolbox of wound care professionals.

Request a Demonstration

Curious to see how adding DEBRICHEM® to your protocols can improve healing rates and reduce healthcare costs in your practice or institution? Request a demonstration today to explore its benefits in action and discover how it can help you deliver more effective wound care while reducing overall costs. Schedule your free product demonstration: https://www.debx-medical.com/request-a-demonstration/

The post Cost-effectiveness of DEBRICHEM® in Managing Hard-to-Heal Venous Leg Ulcers(VLUs) in the UK appeared first on Innovating The Future of Wound Care.

DEBx Medical’s product is an innovative topical dehydrating agent designed to remove infection and biofilm in hard-to-heal wounds, with a single 60-second application.

WHY DEBRICHEM®

A new, disruptive and highly effective method to eliminate biofilm and infection in a matter of seconds in one application.

1. Removes Biofilm & Infection DEBRICHEM® removes the biofilm and infection in a 60-second application, triggering fast granulation and promoting natural healing.

2. Single Application In more than 90% of cases, granulation is achieved after one DEBRICHEM® application, saving time during the treatment process and expediting wound healing.

3. Easy & Fast to Use Due to its fast action and applicability outside the surgery room, DEBRICHEM® can be easily integrated within standard wound care procedures.

4. Safe on Intact Skin DEBRICHEM® works by withdrawing water from the wound bed materials, and due to the low water content of the outer layer of the epidermis, the surrounding healthy skin is not affected.

REMOVES INFECTION AND BIOFILM

SINGLE APPLICATION: In >90% of cases, granulation is achieved after one DEBRICHEM® application, saving time during the treatment process and expediting wound healing.

EASY AND FAST TO USE: Due to its fast action and applicability outside the surgery room, DEBRICHEM® can easily be integrated within standard wound care procedures.

SAFE ON INTACT SKIN DEBRICHEM® works by withdrawing water from the wound bed materials and due to the low water content of the outer layer of the epidermis, the surrounding healthy skin is not affected.

EFFECTIVE FOR ALL, IDEAL FOR ANTIBIOTIC RESISTANCE

DEBRICHEM® is a dynamic wound care innovation that is ideal for patients suffering from non surgical infected wounds, including those facing antibiotic-resistant challenges. Its chemistry is designed to combat infection without resistance, offering a lasting solution where traditional antibiotics fall short.

Economical and efficient, DEBRICHEM® simplifies treatment, reduces dependency on costly antibiotics, and accelerates healing across the spectrum of patient needs.

REDUCES CHRONIC WOUND PAIN

Chronic pain is a major issue for patients living with hard-to-heal wounds. Pain is caused by the infection and inflammation of the wound. By eliminating the infection, patients experience a significant decrease in pain soon after DEBRICHEM® treatment.

DEBRICHEM® APPLICATION PROCESS

DEBRICHEM® offers a straightforward and fast application process suitable for ambulatory settings, making it accessible for healthcare professionals: doctors and nurses. Unlike traditional debriding methods, it doesn’t require a specific training.

Experience DEBRICHEM® Interactive Application Process:

WHEN TO CONSIDER DEBRICHEM®

DEBRICHEM® can be used by all healthcare professionals in particular wound care specialists, nurses, surgeons, diabetic foot ulcer specialists and vulnologists, to treat all non-surgical hard-to-heal wounds such as Diabetic Foot Ulcers, Venous Ulcers, Post-traumatic skin ulcers, Pressure ulcers.

HOW DEBRICHEM® WORKS

DEBRICHEM® desiccates the biofilm, as well as the residing and planktonic micro-organisms within 60 seconds of application.

By instantly capturing water molecules from any type of exposed biological material, DEBRICHEM® has an immediate dehydrating effect, with no damage to the vital tissue below the wound bed.

Watch DEBRICHEM® Videos.

VIDEO 1: DEBRICHEM® mode of action on animated wound model

VIDEO 2: DEBRICHEM®’s effect on bacteria

VIDEO 3: DEBRICHEM® safe on intact skin

VIDEO 4: DEBRICHEM® application process

WHY DEBRICHEM® IS SAFE ON HEALTHY SKIN

In contrast viable tissue and healthy skin are protected by membrane lipids exposing lower water content. This protects the epidermal layer of the surrounding skin from the desiccation effect. Biofilm is composed of 97% water molecules and microbial aggregates. It is encased within an extracellular matrix of polysaccharides, proteins and glycoproteins.

COST-EFFICIENT SOLUTION

Studies have revealed that DEBRICHEM® is 57% more cost-effective solution compared to wound care standards. It has the potential of saving millions to healthcare systems.

REQUEST A FREE DEBRICHEM® DEMONSTRATION

Request a DEBRICHEM® Demonstration at Your Facility with 3-5 patients! Just visit https://www.debx-medical.com/request-a-demonstration/

1. Fill out a Request Form at: https://www.debx-medical.com/request-a-demonstration/
2. We Contact You: A local specialist will contact you to arrange a convenient time.
3. Plan Together: We’ll help you select 3-5 suitable patients for treatment.
4. On-Site Demonstration: Experience DEBRICHEM® in action, treating patients with expert support.
5. Ongoing Support: Receive continued assistance and resources post-demonstration.

By treating multiple patients in one session:

• Treat Multiple Patients at Once – This gives you a lot of exposure to chemical debridement and how DEBRICHEM® works for different patient needs.
• Hands-On Experience – Get comfortable with using DEBRICHEM® and see its immediate impact on wounds.
• Observe Various Outcomes – Learn to recognize the different results and get ready to explain these effects to your patients with confidence.
• Refine Patient Selection Skills – Discover the versatility of DEBRICHEM® and fine-tune your ability to select the best candidates for treatment.
• Enjoy Ongoing Support – We’re here for follow-up treatments and to help guide each patient’s healing journey.
  

What is DEBRICHEM®?

Topical dehydrating agent intended for non-surgical debridement and treatment of non-surgical infected wounds. The product is intended to be applied by healthcare professionals only.

Why is DEBRICHEM® safe on intact skin?

Biofilm is composed of 97% water molecules and microbial aggregates. DEBRICHEM® binds water molecules. The acidic principle dissociates and produces protons and anions that bind water molecules and release energy. This process triggers a strong exothermic dehydration process. By instantly capturing water molecules from any type of exposed biological material, DEBRICHEM® has an immediate dehydrating effect, with no damage to the vital tissue below the wound bed.

What is DEBRICHEM® used for?

DEBRICHEM® can be used to treat all non-surgical hard-to-heal, and infected wounds such as:

• Diabetic Foot Ulcers
• Venous Leg Ulcers
• Pressure Ulcers
• Vasculitis Ulcers
• Post-surgical Ulcers
• Post-traumatic Skin Ulcers
• Arterial Ulcers

Can I use DEBRICHEM® with Negative Pressure Wound Therapy (NWPT)?

DEBRICHEM® used in combination with NPWT is successful in removing biofilm and necrosis and supports the rapid development of granulation tissue, thus contributing to overall faster healing. According to a recent study involving twelve patients with diverse foot and leg ulcers sheds light on this success. These ulcers varied in type, with an average size of 308 cm2 and an average duration of 13 months. Among them, five were venous leg ulcers, two were arterial, one had a mixed venous/arterial origin, and one stemmed from a post-trauma situation (with an unknown etiology: N=3). Remarkably, all patients achieved complete granulation in an average of 13.2 days.

Read the full article here: https://www.gavinpublishers.com/article/view/combining-an-acidic-compound-and-npwt–debridement-and-granulation-in-leg-and-foot-ulcers

The post DEBRICHEM® INNOVATING THE FUTURE OF WOUND CARE appeared first on Innovating The Future of Wound Care.

At DEBx Medical , we are dedicated to advancing wound care through innovative solutions. With a focus on removing infection and biofilm, DEBx Medical pioneers groundbreaking solutions to address the unique challenges of hard-to-heal wounds.

As part of this commitment, we are proud to announce the launch of our randomized controlled study, which will evaluate the relative effectiveness and safety of chemical wound debridement versus sharp debridement with curette in treating venous and mixed etiology leg ulcers.

Our Solution: Chemical Debridement vs. Sharp Debridement

This randomized controlled study, officially titled A Pilot Study to Investigate the Relative Effectiveness and Safety of Chemical Wound Debridement and Curettage in the Treatment of Venous and Mixed Aetiology Leg Ulcers (ClinicalTrials.gov ID: NCT06652360), compares two methods of debridement:

Chemical Debridement: A non-invasive treatment using a desiccating gel that eradicates biofilm, opening the path to wound healing without the need for scraping.

Sharp Debridement with Curette: A mechanical, standard approach that involves manually scraping away dead tissue from the wound bed.

Both methods are being tested for their effectiveness in reducing wound size, improving tissue condition, and enhancing healing times.

Why This Study Matters: Advancing Evidence-Based Wound Care

Treatment protocols in wound care have remained largely unchanged for decades with clinicians often hesitant to adopt effective, innovative solutions. This randomized controlled study aims to provide solid evidence supporting the effectiveness of integrating innovative chemical debridement agent into standard wound care, offering a valuable opportunity to enhance existing practices.

The Study Approach

The randomized controlled study is going to be conducted in the United Kingdom and focuses specifically on venous and mixed etiology leg ulcers. Researchers aim to understand how both treatments perform in terms of effectiveness—that is, the speed and completeness of healing—and safety, including the risk of complications and adverse events during treatment.

Study Design and Methodology in Accordance with International Good Clinical Practice Standards

Adhering to the latest revision of the international standard for Good Clinical practice, the ISO 14155, this randomized, open-label study will include participants with venous leg ulcers or mixed etiology ulcers, aged 18 years and older. Participants will be randomized into two groups to receive either chemical debridement or sharp debridement with curette. The primary objective is to evaluate the wound surface area reduction and the percentage of slough in the wound bed after 12 weeks of treatment.

We are also assessing several secondary outcomes, including:

• Wound healing, based on the BWAT (wound assessment tool).
• Wound condition, including the level of granulation tissue, slough, exudate, odor, condition of peri-ulcer skin and surrounding skin.
• Health-related quality of life via the WoundQOL questionnaire.
• Pain and comfort as measured using the Visual Analogue Scale.
• Participant and staff acceptance of the debridement methods.

Evidence: What the Randomized Controlled Study Will Measure

The randomized controlled study will evaluate both the primary and secondary outcomes:

• Primary Outcome: Reduction in wound surface area and visible slough after 12 weeks.
• Secondary Outcomes: Wound healing, quality of life, pain, and overall comfort, as well as the safety of each treatment method.

Ensuring Ethical Standards: Approval from the London – Dulwich Research Ethics Committee

We understand that ethical integrity is paramount in any clinical study, and we take our responsibility to patient safety and the ethical considerations seriously. That’s why we are pleased to share that this study has been evaluated and received ethical approval from the London – Dulwich Research Ethics Committee.

The committee’s members reviewed our study amendment and provided a favorable ethical opinion based on the documentation we submitted. This approval is crucial to ensure that our study adheres to the highest standards of patient safety, transparency, and ethical conduct. We are committed to following rigorous protocols to protect participants and maintain the integrity of the research process.

As part of this ethical approval, we will ensure that all participants provide informed consent, that their rights are fully protected, and that their well-being is carefully monitored throughout the trial. Ethical approval was granted with the understanding that we are committed to conducting this study with the utmost respect for patients and their privacy.

A Partnership Built on Expertise

We are excited to announce our collaboration on this study with Dr. Steven Jeffery, Medical Director & Consultant Burns and Plastic Surgeon at Pioneer Wound Healing & Lymphoedema Care Ltd. His expertise in wound care, combined with his experience in treating complex burns and plastic surgery cases, brings invaluable insight to this study.

Steven’s leadership in the field of wound healing will help guide the study with his clinical experience and patient-centered approach, ensuring the highest standards of care and safety. His contribution, along with that of Pioneer Wound Clinics, ensures that this randomized controlled study adheres to best practices in clinical research and ethical standards.

The Benefits of This Randomized Controlled Study for Patients and Healthcare Providers

For Patients: Faster, less invasive debridement methods mean reduced re-infection risk, freedom from repeated treatments, and quicker recovery. If chemical debridement proves effective, it could provide a better solution for chronic leg ulcer patients.

For Healthcare Professionals: By comparing two widely used methods, this study provides crucial data on the safest and most effective approach to treating venous and mixed etiology leg ulcers.

For Healthcare Providers: Reducing complications and improving healing times can lead to better patient outcomes and potentially lower costs associated with long-term wound care.

Next Steps and Implications for Wound Care

As this randomized controlled study progresses, more data will be gathered on the safety profile and long-term benefits of chemical wound debridement. If these initial findings are confirmed, this could lead to wider adoption of chemical debridement as a standard treatment for leg ulcers, offering a less invasive and more comfortable option for patients.

This research underscores the importance of continued innovation in wound care treatments. Understanding which methods work best can help improve patient outcomes, reduce healthcare costs, and enhance the quality of life for those affected by chronic wounds.

Stay Connected

If you are a healthcare provider or researcher interested in the study or have any questions regarding the ethical processes we’ve followed, we invite you to visit our website: https://www.debx-medical.com/ or contact us via info@debx-medical.com.

We also invite you to Book a Demonstration at your own clinic to explore the impact of implementing DEBRICHEM® in your wound care routine: https://www.debx-medical.com/request-a-demonstration/

#WoundCare #ClinicalTrials #VenousLegUlcers #ChronicWounds #EthicalResearch #PatientSafety #HealthcareInnovation #DEBxMedical #PioneerWoundClinics #StevenJeffery #MedicalResearch

The post Clinical Trial on Chemical Debridement Addressing the Challenge of Venous and Mixed Etiology Leg Ulcers appeared first on Innovating The Future of Wound Care.