Study Device Debridement for Wound Care
(EVIDENT Trial)
What You Need to Know Before You Apply
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.
Is Study Device Debridement generally safe for humans?
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.12678
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.2891011
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Medaxis debritom+ or standard of care (sharp debridement using scalpel) for wound care management
Follow-up
Participants are monitored for wound healing rates, success of advanced wound care treatments, and financial costs
What Are the Treatments Tested in This Trial?
Interventions
- SOC Debridement
- Study Device Debridement
Study Device Debridement is already approved in European Union, United States, Switzerland for the following indications:
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Who Is Running the Clinical Trial?
Medaxis, LLC
Lead Sponsor
NAMSA
Collaborator