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| Name | Class |
|---|---|
| Vomaris Innovations | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42164272 | Derived | 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. |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Bioelectric Dressing Intervention (Left Armpit) and Standard of Care Dressing (Right Armpit) | Participants randomized to receive the bioelectric dressing on the left armpit and the standard of care dressing on the right armpit following de-roofing surgery. |
| FG001 | Bioelectric Dressing Intervention (Right Armpit) and Standard of Care Dressing (Left Armpit) | Participants randomized to receive the bioelectric dressing on the right armpit and the standard of care dressing on the left armpit following de-roofing surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Intervention Group: Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on the right armpit and will receive the standard gauze dressing for up to 8 weeks on the left armpit. Procellera 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. Standard Gauze Dressing: Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline. Control Group: Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on the left armpit and will receive the standard gauze dressing for up to 8 weeks on the right armpit. Procellera 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. Standard Gauze Dressing: Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Healing Rate | The healing rate of post-surgical wounds will be reported as the area reduction in cm^2/per day. | Posted | Mean | Standard Deviation | cm^2/day | Up to 8 weeks | armpits | armpits |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group (Bioelectric Dressing) | Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on one axilla and will receive the standard gauze dressing for up to 8 weeks on the other axilla. Procellera 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | 305-243-4472 | hlevtov@med.miami.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2023 | May 16, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Standard Gauze Dressing | Other | Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline. |
|
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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on one axilla and will receive the standard gauze dressing for up to 8 weeks on the other axilla. Standard Gauze Dressing: Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline. |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | days | Up to 8 weeks |
|
|
|
| Secondary | Number of Subjects With Complete Healing | The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported. | Posted | Number | participants | Up to 8 weeks |
|
|
|
| Secondary | 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. | Posted | Number | participants | Up to 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 8 weeks |
|
|
|
| Secondary | 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. | Posted | Number | participants | Up to 8 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Full Range | units on a scale | Up to 8 weeks | armpits | armpits |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 8 weeks |
|
|
|
| Secondary | Shoulder Range of Motion | Shoulder range of motion will be measured using a goniometer. Participant number with preserved range of motion will be reported. | Posted | Number | participants | Up to 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | dressing per day | Up to 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 2 (24 hours post procedure) |
|
|
|
| Secondary | Days of Work Lost | Number of reported days of work lost due to the procedure will be reported | Posted | Mean | Standard Deviation | Days | Up to 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Up to 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | log CFU/gram | Up to 8 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control Group (Standard of Care) | Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on one axilla and will receive the standard gauze dressing for up to 8 weeks on the other axilla. Standard Gauze Dressing: Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |