Trial Outcomes & Findings for A Bioelectric Dressing for Post De-Roofing Treatment of HS (NCT NCT05057429)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Up to 8 weeks

Results posted on

2026-03-06

Participant Flow

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.

Unit of analysis: armpits/axillae

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	6 12	6 12
Overall Study COMPLETED	6 12	6 12
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Bioelectric Dressing for Post De-Roofing Treatment of HS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 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.
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants
Sex: Female, Male Female	9 Participants n=41 Participants
Sex: Female, Male Male	3 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	3 Participants n=41 Participants
Race (NIH/OMB) White	9 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 armpits 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.	Control Group (Standard of Care) n=12 armpits 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.
Healing Rate	.45 cm^2/day Standard Deviation .28	.39 cm^2/day Standard Deviation .28

SECONDARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Average Time to Complete Healing	56 days Standard Deviation 0	56 days Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Number of Subjects With Complete Healing	2 participants	4 participants

SECONDARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Number of Subjects With Nodule and/or Tunnel Recurrence	2 participants	6 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Average Pain as Assessed by the Visual Analogue Scale (VAS)	-1.5 units on a scale Standard Deviation 2.0	-1.9 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Number of Subjects With Tenderness at Surgical Sites	12 participants	11 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 armpits 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.	Control Group (Standard of Care) n=12 armpits 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.
Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale	2.4 units on a scale Interval 0.0 to 8.0	2.7 units on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Amount of Exudate at Surgical Site	-0.17 units on a scale Standard Deviation 1.0	.33 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Shoulder Range of Motion	11 participants	11 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Number of Dressings Used Through to Healing Day	4.3 dressing per day Standard Deviation 5.0	4.8 dressing per day Standard Deviation 4.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Average Pain as Assessed by the Visual Analogue Scale (VAS)	5.6 units on a scale Standard Deviation 3.1	3.6 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Up to 8 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Days of Work Lost	10.5 Days Standard Deviation 11.3	10.5 Days Standard Deviation 11.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Change in Quality of Life as Measured by the DLQI	-5.3 units on a scale Standard Deviation 4.9	-5.3 units on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group (Bioelectric Dressing) n=12 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. 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.	Control Group (Standard of Care) n=12 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.
Tissue Analysis of Microbiome	-.085 log CFU/gram Standard Deviation .45	.070 log CFU/gram Standard Deviation .34

Adverse Events

Intervention Group (Bioelectric Dressing)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group (Standard of Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hadar Lev-Tov, MD

University of Miami

Phone: 305-243-4472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place