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 — DEVICE
    Procellera 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 — OTHER
    Standard 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 Dressing
    Participants 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 Dressing
    Participants 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)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

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