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

Part of paid clinical trials in Bradenton, Florida.

Sponsor
Medaxis, LLC
Study ID
NCT04920253
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Study Device Debridement — DEVICE
    debritom+ water jet debridement
  • SOC Debridement — DEVICE
    Sharp Scalpel

Study Details

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.

Key Dates

Start date
Nov 29, 2021
Status verified
Nov 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: debritom+
    Group 1: Medaxis debritom+
  • Active Comparator: Sharp Scalpel
    Group 2: SOC (Sharp Scalpel Debridement)

Primary Outcome Measure

Wound Closure [ Time Frame: 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MCR Health, Inc.BradentonFlorida34208
Melvin B Price, DPM

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MCR Health, Inc.· Bradenton, FL

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