A Bioelectric Dressing for Post De-Roofing Treatment of HS

NCT05057429 | Completed Results FDA Device

• 1 other identifier: 20210621
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Average Time to Complete Healing

  Up to 8 weeks

• Number of Subjects With Complete Healing

  Up to 8 weeks

• Number of Subjects With Nodule and/or Tunnel Recurrence

  Up to 8 weeks

• Average Pain as Assessed by the Visual Analogue Scale (VAS)

  Up to 8 weeks

• Number of Subjects With Tenderness at Surgical Sites

  Up to 8 weeks

Study Arms (2)

Bioelectric Dressing

EXPERIMENTAL

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.

Device: Bioelectric Dressing; Other: Standard Gauze Dressing

Standard Gauze Dressing

EXPERIMENTAL

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.

Device: Bioelectric Dressing; Other: Standard Gauze Dressing

Interventions

Standard Gauze Dressing OTHER

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

Bioelectric Dressing; Standard Gauze Dressing

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.

Bioelectric Dressing; Standard Gauze Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Vomaris Innovations: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Hadar Lev-Tov, MD
• Organization: University of Miami

hlevtov@med.miami.edu

305-243-4472

Study Officials

• Hadar Lev-Tov, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 27, 2021
• Study Start: October 11, 2021
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)