A Bioelectric Dressing for Post De-Roofing Treatment of HS
Part of paid clinical trials in Miami, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT05057429
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bioelectric Dressing — DEVICEProcellera is single layer, broad-spectrum antimicrobial wound dressing. Embedded in the dressing are microcell batteries made of elemental silver and zinc applied in a dot-matrix pattern. The bioelectric dressing will be applied to surgical site wound with a hydrogel.
- Standard Gauze Dressing — OTHERStandard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
Study Details
The primary purpose of this study is to test if the use of a bioelectric dressing can improve healing after a surgical procedure called de-roofing.
Key Dates
- Start date
- Oct 11, 2021
- Status verified
- Feb 2026
- Primary completion
- May 15, 2024
- Completion
- May 15, 2024
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Bioelectric DressingParticipants acting as their own control. Each participant is counted as 2 sites (2 axilla). Participants undergoing standard of care deroofing surgery will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing, and the contralateral axilla will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
- Experimental: Standard Gauze DressingParticipants acting as their own control. Each participant is counted as 2 sites (2 axilla). Participants undergoing standard of care deroofing surgery will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing, and the contralateral axilla will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
Primary Outcome Measure
Healing Rate [ Time Frame: Up to 8 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | - |
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