Brief 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.
Condition or disease
Intervention/treatment
Phase
Diabetic Foot Ulcer Venous Leg Ulcer Surgical Wound Dehiscence Traumatic Wounds
Device: Study Device Debridement Device: SOC Debridement
Not Applicable
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 water jet FDA registered Class II device, which will be used within the cleared intended use of wound lavage.
Source: View full study details on ClinicalTrials.gov
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