An interventional study of Bioelectric Dressing and Standard Gauze Dressing in Hidradenitis Suppurativa, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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 of care non-adherent gauze dressing will be applied to surgical site with vaseline.
Healing Rate
The healing rate of post-surgical wounds will be reported as the area reduction in cm\^2/per day.
Time frame: Up to 8 weeks
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 2 (24 hours post procedure)
Days of Work Lost
Number of reported days of work lost due to the procedure will be reported
Time frame: 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.
Time frame: 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.
Time frame: Up to 8 weeks
Participants undergoing standard of care deroofing surgery in a medical clinic office will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing (e.g., left armpit) and the contralateral axilla (right axilla) will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
| Milestone | Bioelectric Dressing Intervention (Left Armpit) and Standard of Care Dressing (Right Armpit) | Bioelectric Dressing Intervention (Right Armpit) and Standard of Care Dressing (Left Armpit) |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
The healing rate of post-surgical wounds will be reported as the area reduction in cm\^2/per day.
| cm^2/day | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Healing Rate | .45 ± .28 | .39 ± .28 |
The average time, measured in the number of days, to complete healing as assessed by treating physician will be reported
| days | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Average Time to Complete Healing | 56 ± 0 | 56 ± 0 |
The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported.
| participants | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Number of Subjects With Complete Healing | 2 | 4 |
The number of subjects with nodule and/or tunnel recurrence, as evaluated by treating physician, will be reported.
| participants | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Number of Subjects With Nodule and/or Tunnel Recurrence | 2 | 6 |
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.
| units on a scale | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Average Pain as Assessed by the Visual Analogue Scale (VAS) | -1.5 ± 2.0 | -1.9 ± 2.4 |
The number of subjects with tenderness at surgical sites, as evaluated by treating physician, will be reported.
| participants | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Number of Subjects With Tenderness at Surgical Sites | 12 | 11 |
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).
| units on a scale | Bioelectric Dressing (Left Axilla) and Standard of Care Dressing (Right Axilla) | Bioelectric Dressing (Right Axilla) and Standard of Care Dressing (Left Axilla) |
|---|---|---|
| Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale | 2.4 (0 to 8) | 2.7 (0 to 7) |
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.
| units on a scale | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Amount of Exudate at Surgical Site | -0.17 ± 1.0 | .33 ± 1.3 |
Shoulder range of motion will be measured using a goniometer. Participant number with preserved range of motion will be reported.
| participants | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Shoulder Range of Motion | 11 | 11 |
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.
| dressing per day | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Number of Dressings Used Through to Healing Day | 4.3 ± 5.0 | 4.8 ± 4.9 |
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.
| units on a scale | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Average Pain as Assessed by the Visual Analogue Scale (VAS) | 5.6 ± 3.1 | 3.6 ± 2.3 |
Number of reported days of work lost due to the procedure will be reported
| Days | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Days of Work Lost | 10.5 ± 11.3 | 10.5 ± 11.3 |
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.
| units on a scale | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Change in Quality of Life as Measured by the DLQI | -5.3 ± 4.9 | -5.3 ± 4.9 |
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.
| log CFU/gram | Intervention Group (Bioelectric Dressing) | Control Group (Standard of Care) |
|---|---|---|
| Tissue Analysis of Microbiome | -.085 ± .45 | .070 ± .34 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group (Bioelectric Dressing) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Control Group (Standard of Care) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 9 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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