Hidradenitis SuppurativaNCT05057429
A Bioelectric Dressing for Post De-Roofing Treatment of HS
A study testing Bioelectric Dressing and Standard Gauze Dressing in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Bioelectric Dressing and Standard Gauze Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 15 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Bioelectric Dressing, Standard Gauze Dressing
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectric DressingDevice
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 DressingOther
Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Bioelectric Dressing; Other: Standard Gauze Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate
The healing rate of post-surgical wounds will be reported as the area reduction in cm^2/per day.
Measured: Up to 8 weeks
Secondary outcomes (13)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 2 (24 hours post procedure)
Days of Work Lost
Number of reported days of work lost due to the procedure will be reported
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start11 Oct 2021
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Vomaris Innovations
- Responsible party
- Principal investigator, Hadar Lev-Tov, University of Miami
- Investigators
- Hadar Lev-Tov, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057429
- Sponsor's protocol ID
- 20210621
- Status last verified
- Feb 2026
- First submitted
- 15 Sep 2021
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yaghi M, Gonzalez T, Vecin N, Pastar I, Lev-Tov H. A bioelectric dressing improves postderoofing outcomes in hidradenitis suppurativa by microbiome modulation: A split-body, randomized clinical trial. JID Innov. 2026 Feb 16;6(4):100461. doi: 10.1016/j.xjidi.2026.100461. eCollection 2026 Jul.
PubMed 42164272
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioelectric Dressing for Post De-Roofing Treatment of Hidradenitis Suppurativa (HS)
- ClinicalTrials.gov ID
- NCT05057429
- Acronym / sponsor ID
- 20210621
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Vomaris Innovations
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Posted 6 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioelectric Dressing | Experimental | Device: Bioelectric Dressing, Other: Standard Gauze DressingParticipants 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. |
| Standard Gauze Dressing | Experimental | Device: Bioelectric Dressing, Other: Standard Gauze DressingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectric DressingProcellera 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. | Device | Bioelectric Dressing, Standard Gauze Dressing |
| Standard Gauze DressingStandard of care non-adherent gauze dressing will be applied to surgical site with vaseline. | Other | Bioelectric Dressing, Standard Gauze Dressing |
Primary outcome
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.
13 secondary outcomes
Average Time to Complete Healing
Time frame: Up to 8 weeks
Number of Subjects With Complete Healing
Time frame: Up to 8 weeks
Number of Subjects With Nodule and/or Tunnel Recurrence
Time frame: Up to 8 weeks
Average Pain as Assessed by the Visual Analogue Scale (VAS)
Time frame: Up to 8 weeks
Number of Subjects With Tenderness at Surgical Sites
Time frame: Up to 8 weeks
Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale
Time frame: Up to 8 weeks
Amount of Exudate at Surgical Site
Time frame: Up to 8 weeks
Shoulder Range of Motion
Time frame: Up to 8 weeks
Number of Dressings Used Through to Healing Day
Time frame: Up to 8 weeks
Average Pain as Assessed by the Visual Analogue Scale (VAS)
Time frame: Day 2 (24 hours post procedure)
Days of Work Lost
Time frame: Up to 8 weeks
Change in Quality of Life as Measured by the DLQI
Time frame: Baseline, Up to 8 weeks
Tissue Analysis of Microbiome
Time frame: Up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42164272Yaghi M, Gonzalez T, Vecin N, Pastar I, Lev-Tov H. A bioelectric dressing improves postderoofing outcomes in hidradenitis suppurativa by microbiome modulation: A split-body, randomized clinical trial. JID Innov. 2026 Feb 16;6(4):100461. doi: 10.1016/j.xjidi.2026.100461. eCollection 2026 Jul.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Lev-Tov, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectric Dressing and Standard Gauze Dressing in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Rate (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.