Evaluating Medaxis debritom Micro Water Jet Versus Standard Sharp Scalpel Debridement for Wound Healing in Adults at a Single Center

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.

Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center