Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Medaxis, LLC
Summary
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.
Description
The purpose of this clinical investigation is to assess the clinical performance of the Medaxis debritom+ versus standard of care (sharp debridement using scalpel) in the real world practice of wound care management in a single center trial by collecting data on wound healing rates over time, success of advanced wound care treatments, and downstream financial costs in the treatment of diabetic foot ulcers, venous leg ulcers, dehisced surgical wounds and traumatic wounds. Medaxis debritom+TM is an advanced micro fluid jet FDA registered Class II device, which will be used within the cleared int…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: General Potential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization: 1. At least 18 years old. 2. The index wound (i.e. current episode of the wound or ulceration) 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. 3. The index wound is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1. 4. Subject understands and is willing to participate in the clinical study and can comply with…
Interventions
- DeviceStudy Device Debridement
debritom+ water jet debridement
- DeviceSOC Debridement
Sharp Scalpel
Location
- MCR Health, Inc.Bradenton, Florida