A Bioelectric Dressing for Post De-Roofing Treatment of HS

A Bioelectric Dressing for Post De-Roofing Treatment of Hidradenitis Suppurativa (HS)

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Other: Standard Gauze Dressing; Device: Bioelectric Dressing

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Rate	The healing rate of post-surgical wounds will be reported as the area reduction in cm^2/per day.	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Time to Complete Healing	The average time, measured in the number of days, to complete healing as assessed by treating physician will be reported	Up to 8 weeks
Number of Subjects With Complete Healing	The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported.	Up to 8 weeks
Number of Subjects With Nodule and/or Tunnel Recurrence	The number of subjects with nodule and/or tunnel recurrence, as evaluated by treating physician, will be reported.	Up to 8 weeks
Average Pain as Assessed by the Visual Analogue Scale (VAS)	The average pain will be measured using the VAS with scores ranging from 0-100 with the higher score indicating more severe pain. Mean change in score will be compared from baseline to last visit.	Up to 8 weeks
Number of Subjects With Tenderness at Surgical Sites	The number of subjects with tenderness at surgical sites, as evaluated by treating physician, will be reported.	Up to 8 weeks
Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale	The Modified Vancouver Scar Scale (MVSS) is a validated clinical tool used to assess scar quality. It includes four subscales: Vascularity (0-3), Pigmentation (0-2), Pliability (0-5), Height/Thickness (0-3). Each subscale is scored independently, and the scores are summed to produce a total score ranging from 0 to 13. Higher scores indicate worse scar quality (greater abnormality). Lower scores indicate better scar quality (closer to normal skin).	Up to 8 weeks
Amount of Exudate at Surgical Site	The amount of exudate at surgical site will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking). Mean change in score will be compared from baseline to last visit.	Up to 8 weeks
Shoulder Range of Motion	Shoulder range of motion will be measured using a goniometer. Participant number with preserved range of motion will be reported.	Up to 8 weeks
Number of Dressings Used Through to Healing Day	The number of dressings used through to healing day will be reported. Mean change in number of dressings will be compared from baseline to last visit.	Up to 8 weeks
Average Pain as Assessed by the Visual Analogue Scale (VAS)	The average pain will be measured using the VAS with scores ranging from 0-100 with the higher score indicating more severe pain. Mean score on day 2 will be reported.	Day 2 (24 hours post procedure)
Days of Work Lost	Number of reported days of work lost due to the procedure will be reported	Up to 8 weeks
Change in Quality of Life as Measured by the DLQI	Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life. Mean change in score will be compared from baseline to last visit.	Baseline, Up to 8 weeks
Tissue Analysis of Microbiome	As measured by quantitative 16s recombinant DNA (rDNA) Polymerase Chain Reaction for bacterial enumeration from punch biopsy and biofilm samples. Mean change in bacterial load from baseline and final visit will be compared and reported in log Colony Forming Unit (CFU)/gram.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Vomaris Innovations
• Investigators: Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: 20210621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No