Study Device Debridement for Wound Care

(EVIDENT Trial)

Overseen By Sharona Segal-Leibovich

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medaxis, LLC

Must not be taking: Immune-suppressants, COX-2 inhibitors

Disqualifiers: Cancer, HIV, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

180 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like immune-suppressants, selective COX-2 inhibitors, or investigational drugs. It's best to discuss your current medications with the trial team to see if they are allowed.

What data supports the effectiveness of this treatment for wound care?

The research highlights that debridement, including methods like surgical and mechanical debridement, is crucial for wound healing by removing dead tissue and reducing infection. Although there is no consensus on the best method, debridement is widely recognized as essential for preparing the wound bed and promoting healing. ^{1 2 3 4 5}

Is Study Device Debridement generally safe for humans?

Debridement, including methods like sharp debridement, is essential for wound healing but can carry risks if not done correctly. It's important for healthcare providers to understand the advantages and disadvantages of each method to minimize risks and ensure safety. ^{5 6 7 8 9}

How is the Study Device Debridement treatment different from other wound care treatments?

The Study Device Debridement treatment, known as Debritom+ or Medaxis Debritom+, is unique because it offers a novel approach to wound debridement, potentially minimizing pain and reducing the risk of deeper injury compared to traditional methods. This device may provide a more uniform removal of dead tissue, which can be beneficial for hard-to-heal wounds. ^{2 5 6 10 11}

Research Team

Melvin B Price, DPM

Principal Investigator

MCR Health Inc.

Eligibility Criteria

Adults over 18 with wounds like venous ulcers, diabetic foot, or surgical wound separation that have persisted for more than 4 weeks but less than a year. Participants must understand the study and commit to weekly visits. Wounds should be between 1-25 cm2 in size. Exclusions include obesity (BMI >55), certain infections, poor diabetes control (HbA1c >12%), bone infections, severe organ exposure in wounds, immune-suppressant use within a month prior to the study.

Inclusion Criteria

At least 18 years old

The index wound has been present for greater than 4 weeks prior to SV 1 and has had less than 1 year of documented medical treatment, as of the subject's consent for the study participation

Subject understands and is willing to participate in the clinical study and can comply with weekly visits

Exclusion Criteria

You have had radiation treatment at the area where the wound is located.

You weigh more than 55 pounds for every 4 feet of your height.

Index wound has been previously treated or will need to be treated with any prohibited therapies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Medaxis debritom+ or standard of care (sharp debridement using scalpel) for wound care management

20 weeks

Follow-up

Participants are monitored for wound healing rates, success of advanced wound care treatments, and financial costs

4 weeks

Treatment Details

Interventions

• SOC Debridement
• Study Device Debridement

Trial Overview This trial is testing Medaxis debritom+ against standard care for wound debridement. It's designed as a prospective, single-blinded RCT at one center where participants are randomly assigned to either the new device or standard treatment while following normal advanced wound care practices.

Participant Groups

Group I: debritom+ Experimental Treatment 1 Intervention

Group 1: Medaxis debritom+

Group II: Sharp Scalpel Active Control 1 Intervention

Group 2: SOC (Sharp Scalpel Debridement)

Study Device Debridement is already approved in European Union, United States, Switzerland for the following indications:

Approved in European Union as Debritom+ for:

• Chronic lower extremity ulcers
• Diabetic foot ulcers

Approved in United States as Debritom+ for:

• Chronic lower extremity ulcers
• Diabetic foot ulcers

Approved in Switzerland as Debritom+ for:

• Chronic lower extremity ulcers
• Diabetic foot ulcers

Who Is Running the Clinical Trial?

Medaxis, LLC

Lead Sponsor

Trials

2

Recruited

400+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Findings from Research

Collagenase (Santyl) was the most effective debridement method for achieving a clean wound bed in pressure ulcer management, with a 70% success rate at 2 weeks, compared to lower rates for other methods: 57% for fibrinolysin, 50% for autolysis, and 30% for wet-to-dry dressings.

Collagenase also had the lowest total treatment cost at $610.96 for one month, making it not only effective but also cost-effective compared to other debridement methods, which ranged from $920.73 to $1,008.72.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of 4 methods of debridement using a decision analysis methodology. Mosher, BA., Cuddigan, J., Thomas, DR., et al.[2009]

The article reviews six methods of wound debridement—surgical, mechanical, autolytic, enzymatic, chemical, and biological—highlighting their unique advantages and limitations in promoting wound healing.

Despite the advancements in wound management and debridement techniques, there is no consensus in the literature on the most effective method, indicating a need for further research and standardization in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current methods for wound debridement]. Iuonuţ, AM., Gongănău, DN., Precup, CG., et al.[2011]

The O-POSSUM scoring system effectively predicted 30-day postoperative mortality in bedridden patients undergoing debridement for pressure ulcers, with a mean predicted mortality of 47% for those who died compared to 18% for survivors.

The significant difference in predicted mortality (p=0.01) indicates that O-POSSUM can be a valuable tool for assessing surgical risks in high-risk patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopaedic POSSUM scoring system: an assessment of the risk of debridement in patients with pressure sores. Kurita, M., Ichioka, S., Oshima, Y., et al.[2016]

Surgical and hydrosurgical debridement techniques were found to be effective for treating leg ulcers, with conventional surgical debridement showing a significantly greater reduction in wound size and higher healing rates.

Among alternative methods, manuka honey demonstrated a significant reduction in wound surface area compared to standard treatments, while other techniques like autolytic and enzymatic debridement showed varying effectiveness, indicating the need for further research to confirm their impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on wound healing and efficacy of various leg ulcer debridement techniques. Doerler, M., Reich-Schupke, S., Altmeyer, P., et al.[2012]

Debridement is essential for preparing wound beds by removing nonviable tissue and controlling factors that hinder healing, such as inflammation and infection.

Choosing the appropriate debridement method is crucial, as using the wrong technique can delay healing, increase patient discomfort, and raise healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Debridement and wound bed preparation. Falabella, AF.[2022]

The metallic scrub sponge has been shown to be a safe and effective tool for wound debridement in over 2500 burn patients, particularly beneficial for deep second-degree burns, as it allows for quick and gentle removal of necrotic tissue without harming viable tissue.

This method preserves the skin's ability to heal naturally and is cost-effective, easy to access, and has minimal adverse effects, making it a strong candidate for first-line wound preparation before skin grafting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrub Sponge as A Wound Debridement Device. Ayaz, M.[2022]

Wound debridement is crucial for preparing the wound bed by removing nonviable tissue, which promotes healing and lowers the risk of local infections.

Regular maintenance debridement of necrotic tissue and excessive bacteria is necessary to ensure that wounds can heal effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The necessity of wound debridement. Spear, M.[2010]

The article systematically reviews evidence on wound debridement for chronic wounds, highlighting its importance in promoting healing.

Data from existing randomized controlled trials were collated, providing a comprehensive overview of the efficacy of different debridement methods in managing chronic wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Debridement of chronic wounds: a qualitative systematic review of randomized controlled trials. Hoppe, IC., Granick, MS.[2018]

Sharp debridement is an effective method for promoting wound healing, but it comes with significant clinical risks that need to be managed carefully.

A new course developed at King's College, London, aims to assess the competence of healthcare professionals in performing this high-risk procedure, highlighting the importance of collaboration between education and clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical competence in sharp debridement: an innovative course. Bentley, J., Bishai, P., Foster, A., et al.[2016]

The EZ-Debride tool effectively removes nonviable tissue from hard-to-heal wounds with minimal discomfort, showing an average pain increase of only 0.6 points during the procedure.

In 69% of cases, the tool significantly reduced bacterial load, with complete resolution in 19% of wounds, indicating its efficacy in improving wound care outcomes similar to traditional sharp debridement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel debridement device for the treatment of hard-to-heal wounds: a prospective trial. Al-Jalodi, O., Serena, LM., Breisinger, K., et al.[2022]

Debridement is crucial for effective wound healing as it removes harmful materials that can delay recovery, leading to improved microcirculation, reduced inflammation, and lower infection risks.

The choice of debridement technique should be tailored to individual factors such as the type and depth of the wound, presence of biofilm, and patient preferences, highlighting the importance of personalized treatment in wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound debridement products and techniques: clinical examples and literature review. Nowak, M., Mehrholz, D., Barańska-Rybak, W., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcomes of 4 methods of debridement using a decision analysis methodology. [2009]

2. Romania pubmed.ncbi.nlm.nih.gov

[Current methods for wound debridement]. [2011]

3. England pubmed.ncbi.nlm.nih.gov

Orthopaedic POSSUM scoring system: an assessment of the risk of debridement in patients with pressure sores. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

Impact on wound healing and efficacy of various leg ulcer debridement techniques. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Debridement and wound bed preparation. [2022]

6. Iran pubmed.ncbi.nlm.nih.gov

Scrub Sponge as A Wound Debridement Device. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The necessity of wound debridement. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Debridement of chronic wounds: a qualitative systematic review of randomized controlled trials. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Clinical competence in sharp debridement: an innovative course. [2016]

10. England pubmed.ncbi.nlm.nih.gov

A novel debridement device for the treatment of hard-to-heal wounds: a prospective trial. [2022]

11. Poland pubmed.ncbi.nlm.nih.gov

Wound debridement products and techniques: clinical examples and literature review. [2022]