NCT04920253

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Medaxis, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Foot Ulcer
• Venous Leg Ulcer
• Surgical Wound Dehiscence
• Traumatic Wounds

Interventions

Type	Name	Description
DEVICE	Study Device Debridement	debritom+ water jet debridement
DEVICE	SOC Debridement	Sharp Scalpel

Timeline

• Start date: 2021-11-29
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2021-06-09
• Last updated: 2024-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study