A Bioelectric Dressing for Post De-Roofing Treatment of HS

NCT05057429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-06

Study results available
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Summary

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.

Conditions

Interventions

OTHER

Standard Gauze Dressing

Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.

DEVICE

Bioelectric Dressing

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.

Sponsors & Collaborators

  • Vomaris Innovations

    collaborator INDUSTRY
  • University of Miami

    lead OTHER

Principal Investigators

  • Hadar Lev-Tov, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2024-05-15
Completion
2024-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05057429 on ClinicalTrials.gov