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Real World Evidence With the Debritom+ TM Novel Micro Water Jet Technology at a Single Wound Center — EVIDENT  

Diabetic Foot Ulcer Clinical Trial

Official title:
Real World Evidence With the Debritom+ TM Novel Micro Water Jet Technology at a Single Wound Center

Clinical Trial 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.

Clinical Trial 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 intended use of wound therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04920253
Study type Interventional
Source Medaxis, LLC
Contact Tammy Davis, BSN
Phone 9372415621
Email tdavis@namsa.com
Status Recruiting
Phase N/A
Start date November 29, 2021
Completion date December 2023
View Details
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