Actively Recruiting
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Led by Medaxis, LLC · Updated on 2024-11-21
180
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Medaxis, LLC
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance and cost-effectiveness of the Medaxis debritom+ device compared with the standard sharp scalpel debridement method in treating various types of wounds, including diabetic foot ulcers, venous leg ulcers, surgical wound dehiscence, and traumatic wounds. The study is a prospective, single-blinded, randomized controlled trial conducted at a single wound care center. It aims to collect data on wound healing rates, success of advanced wound care treatments, and financial costs in real-world wound care management. Participants will be randomly assigned to one of two groups: one using the Medaxis debritom+ micro water jet device for debridement, and the other receiving standard care using sharp scalpel debridement. Both groups will continue with normal advanced wound care practices. The Medaxis debritom+ device is an FDA-registered Class II device intended for wound therapy. The study treatment and care are provided for a period of 20 weeks. During the trial, participants will attend weekly visits to monitor wound healing progress. Researchers will evaluate wound closure, complications, the use of advanced wound care treatments, and the proportion of wounds healed over the 20-week study period. Data on financial costs associated with treatment will also be collected. Participants will be assessed using vascular tests and wound grading systems relevant to their condition. Safety and adherence to treatment protocols will be closely monitored throughout the study.
CONDITIONS
Brief Title
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Current wound present for more than 4 weeks and less than 1 year of documented medical treatment
- Wound size between 1.0 cm2 and 25 cm2 at the first study visit
- Willing and able to participate and comply with weekly visits
- Signed informed consent form before any study-specific procedures
- For diabetic foot ulcers: Wagner Grade 1 or 2 without abscess or osteomyelitis, largest ulcer evaluated if multiple, offloaded for at least 14 days prior to randomization, adequate circulation confirmed by vascular assessments
- For venous leg ulcers: wounds classified by CEAP system, largest ulcer evaluated if multiple, adequate circulation confirmed by vascular assessments
- For surgical wound dehiscence: wounds classified by Sandy Grading System excluding severe grades
- For traumatic wounds: wounds classified by CDC Surgical Wound Classification excluding dirty infected and deep incisional infections
You will not qualify if you...
- Wounds suspicious for cancer or with carcinoma diagnosis
- Treatment with immune-suppressants, cytotoxic chemotherapy, or topical steroids to the wound within 1 month prior to first visit or expected during study
- Use of selective COX-2 inhibitors
- Use of investigational drugs or devices within 30 days prior to first visit
- History of radiation at the wound site
- Use of prohibited therapies on the wound
- Diagnosis of HIV, Hepatitis C, or other contagious diseases
- Conditions compromising ability to complete the study or poor treatment adherence
- Pregnancy or breastfeeding
- Poorly controlled diabetes (HbA1c >12.0%) within 90 days of randomization
- End-stage renal disease with serum creatinine >3.0 mg/dL within 6 months
- Body mass index over 55
- Significant changes in wound area between first two visits
- Wagner 2 wounds needing bone debridement
- Osteomyelitis or bone infection confirmed within 30 days prior to randomization
- Venous leg ulcers with secondary post thrombotic syndrome, venous obstruction, or skin changes like lipodermatosclerosis
- Severe surgical wound dehiscence (Sandy Grade 3 and 3a)
- Traumatic wounds classified as dirty infected or deep incisional and organ space infections by CDC classification
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 weeks
Participants receive wound debridement using either the Medaxis debritom+ water jet device or sharp scalpel as part of their wound care management.
Weekly visits for up to 20 weeks
Trial Site Locations
Total: 1 location
1
MCR Health, Inc.
Bradenton, Florida, United States, 34208
Actively Recruiting
Research Team
S
Sharona Segal-Leibovich
A
Amy Jo Johnson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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