A Bioelectric Dressing for Post De-Roofing Treatment of HS

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Device: Procellera Bioelectric Dressing
* Other: Standard Gauze Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left Armpit<br>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. | Device: Procellera Bioelectric Dressing<br>* 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.<br>Other: Standard Gauze Dressing<br>* Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.<br>|
| Experimental: Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right Armpit<br>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. | Device: Procellera Bioelectric Dressing<br>* 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.<br>Other: Standard Gauze Dressing<br>* Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average time to complete healing | The average time, measured in days, to complete healing as assessed by treating physician will be reported | 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. | 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 Numerical Rating Scale (NRS) | The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain. | 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 the Hurley Stage score | The Hurley score is staged as: 1 (single or multiple abscesses without sinus tract formation or scarring); 2 (recurrent abscesses with one or more sinus tracts and scarring widely separated by normal skin); 3 (diffuse involvement with multiple sinus tracts and no intervening 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). | Up to 8 weeks | 
| Shoulder range of motion | Shoulder range of motion will be measured using a goniometer | Up to 8 weeks | 
| Number of dressings used through to healing day | The number of dressings used through to healing day will be reported | Up to 8 weeks | 
| Pain after procedure as assessed by the NRS | The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain. | Day 2 (24 hours post procedure) | 
| Days of work lost | Participants 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 | Baseline, Up to 8 weeks | 
| Tissue analysis of microbiome | As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy and biofilm samples. | Up to 8 weeks |