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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare a new wound-cleaning device, Medaxis debritom+ (also known as Study Device Debridement), with the traditional method of using a sharp scalpel to determine which method accelerates wound healing and reduces costs. The focus is on cleaning diabetic foot ulcers, venous leg ulcers, and surgical or traumatic wounds. Individuals with wounds present for more than four weeks but less than a year may be suitable, provided the wound is neither infected nor cancerous. Participants will assist researchers in assessing the impact of this new device on wound care. As an unphased trial, this study offers a unique opportunity to contribute to innovative wound care research.

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 prior data suggests that this device is safe for wound care?

Research has shown that the Medaxis debritom+ is generally safe for wound care. This device uses a tiny water jet to clean wounds, removing harmful tissue while protecting healthy tissue. It is designed to be gentle, reducing the risk of damaging healthy tissue.

Studies have found that patients using this device did not report major problems. The water jet not only cleans effectively but also reduces bacteria in wounds, aiding healing without causing additional harm.

No specific phase information is available, which often indicates that the treatment is already well-understood or approved for similar uses. Therefore, individuals considering joining a trial with this device can expect it to be well-tolerated based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new wound care treatment, debritom+, because it offers a unique approach to debridement. Unlike the standard sharp scalpel debridement method, debritom+ uses an advanced device to remove dead tissue, which may reduce patient discomfort and improve healing time. This innovative device could make wound care more efficient and accessible, potentially transforming the standard of care for patients with chronic wounds.

What evidence suggests that the Study Device Debridement is effective for wound care?

Studies have shown that the Medaxis debritom+ device, which participants in this trial may receive, works faster and more accurately than other wound-cleaning methods. It causes less harm to the surrounding skin, aiding in better wound healing. Research also indicates that this device simplifies wound cleaning, leading to a smoother healing process. The tool aims to initiate wound healing, which can be challenging due to health issues like heart problems or diabetes. Overall, the Medaxis debritom+ offers a promising way to improve wound care outcomes. ^{1 3 4 6 7}

Who Is on the Research Team?

Melvin B Price, DPM

Principal Investigator

MCR Health Inc.

Are You a Good Fit for This Trial?

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

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

Subject must have read and signed the IRB approved Informed Consent Form (ICF) before study specific screening procedures that are not standard of care are undertaken

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04920253?lupd_s=06%2F21%2F2020

Real World Evidence with the Debritom+ TM Novel Micro ... The purpose of this clinical investigation is to assess the clinical performance of the Medaxis debritom+ versus standard of care (sharp debridement using ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/74/NCT04240574/Prot_SAP_002.pdf

Debritom Research Proposal The technology has been shown to be faster, more precise, and results in less tissue damage than other debridement methods10. Debritom+ (Medaxis AG, Baar ...

3. biospace.com biospace.com/medaxis-releases-report-highlighting-consequences-of-poor-wound-debridement

Medaxis Releases report highlighting consequences of ... The goal of debridement is to kick-start the wound healing process. However due to factors such as cardiovascular problems, metabolic disease ...

4. gandn.com gandn.com/products/debritom-device/

Debritom+ Device - G&N Corporate The Debritom+ is an advanced and precise debridement device designed to simplify wound cleansing and support more effective wound healing.

5. publishingimages.s3.amazonaws.com publishingimages.s3.amazonaws.com/eMails/sponsoremail/medaxis/White-Paper_v2.pdf

THE VALUE OF A GOOD DEBRIDEMENT A good debridement is a requirement to kick start wound healing, however 19% of patients who receive wound debridement as an inpatient are readmitted to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04564443

Study Details | NCT04564443 | A Unique Micro Water Jet ... The purpose of this clinical investigation is to assess performance of Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04514783?keyword=%22Wound%22

Healthy Tissue Preservation During Wound Debridement ... Debridement is defined as the removal of foreign material and necrotic tissue from a wound and it can also help to stimulate wound healing. However, not all ...