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Completed

NCT Number: NCT05057429

A Bioelectric Dressing for Post De-Roofing Treatment of 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Healing Rate

    Time frame: Up to 8 weeks

    The healing rate of post-surgical wounds will be reported as the area reduction in cm^2/per day.

Secondary outcomes

  1. Average Time to Complete Healing

    Time frame: Up to 8 weeks

    The average time, measured in the number of days, to complete healing as assessed by treating physician will be reported

  2. Number of Subjects With Complete Healing

    Time frame: Up to 8 weeks

    The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported.

  3. Number of Subjects With Nodule and/or Tunnel Recurrence

    Time frame: Up to 8 weeks

    The number of subjects with nodule and/or tunnel recurrence, as evaluated by treating physician, will be reported.

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

    Time frame: Up to 8 weeks

    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.

  5. Number of Subjects With Tenderness at Surgical Sites

    Time frame: Up to 8 weeks

    The number of subjects with tenderness at surgical sites, as evaluated by treating physician, will be reported.

  6. Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale

    Time frame: Up to 8 weeks

    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).

  7. Amount of Exudate at Surgical Site

    Time frame: Up to 8 weeks

    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.

  8. Shoulder Range of Motion

    Time frame: Up to 8 weeks

    Shoulder range of motion will be measured using a goniometer. Participant number with preserved range of motion will be reported.

  9. Number of Dressings Used Through to Healing Day

    Time frame: Up to 8 weeks

    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.

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

    Time frame: Day 2 (24 hours post procedure)

    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.

  11. Days of Work Lost

    Time frame: Up to 8 weeks

    Number of reported days of work lost due to the procedure will be reported

  12. Change in Quality of Life as Measured by the DLQI

    Time frame: Baseline, Up to 8 weeks

    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.

  13. Tissue Analysis of Microbiome

    Time frame: Up to 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Vomaris Innovations

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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