N/A
N=12
A Bioelectric Dressing for Post De-Roofing Treatment of HS
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT05057429 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Healing Rate — .45; .39 cm^2/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bioelectric Dressing (Device); Standard Gauze Dressing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Healing Rate |
.45; .39 | — |
| SECONDARY Average Time to Complete Healing |
56; 56 | — |
| SECONDARY Number of Subjects With Complete Healing |
2; 4 | — |
| SECONDARY Number of Subjects With Nodule and/or Tunnel Recurrence |
2; 6 | — |
| SECONDARY Average Pain as Assessed by the Visual Analogue Scale (VAS) |
5.6; 3.6 | — |
| SECONDARY Number of Subjects With Tenderness at Surgical Sites |
12; 11 | — |
| SECONDARY Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale |
2.4; 2.7 | — |
| SECONDARY Amount of Exudate at Surgical Site |
-0.17; .33 | — |
| SECONDARY Shoulder Range of Motion |
11; 11 | — |
| SECONDARY Number of Dressings Used Through to Healing Day |
4.3; 4.8 | — |
| SECONDARY Average Pain as Assessed by the Visual Analogue Scale (VAS) |
5.6; 3.6 | — |
| SECONDARY Days of Work Lost |
10.5; 10.5 | — |
| SECONDARY Change in Quality of Life as Measured by the DLQI |
-5.3; -5.3 | — |
| SECONDARY Tissue Analysis of Microbiome |
-.085; .070 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults 18 years old and older.
- Have diagnosis of HS confirmed by a dermatologist
- Have at least two ancillary tunnels in separate anatomical sites
- Able to provide informed consent
Exclusion Criteria
- Individuals who are not yet adults
- Subject is allergic to any of the materials and dressings involved in the procedures
- Women known to be pregnant
- Prisoners
- Subjects, who in the opinion of the PI, cannot comply with hope application of the treatment
Data sourced from ClinicalTrials.gov (NCT05057429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.