A Bioelectric Dressing for Post De-Roofing Treatment of HS

Not Applicable

Active, not recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Device: Procellera Bioelectric Dressing; Other: Standard Gauze Dressing

• Registration Number: NCT05057429
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-27
• Study Start: 2021-10-11
• Status Verified: 2024-07
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right Armpit	Standard Gauze Dressing	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.
Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left Armpit	Procellera Bioelectric Dressing	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.
Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right Armpit	Procellera Bioelectric Dressing	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.
Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left Armpit	Standard Gauze Dressing	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.

Primary Outcome Measures

Name	Time	Method
Healing Rate	Up to 8 weeks	The healing rate of post-surgical wounds will be reported as the area reduction in cm\^2/per day.

Secondary Outcome Measures

Name	Time	Method
Average time to complete healing	Up to 8 weeks	The average time, measured in days, to complete healing as assessed by treating physician will be reported
Number of subjects with complete healing	Up to 8 weeks	The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported.
Number of subjects with nodule and/or tunnel recurrence	Up to 8 weeks	The number of subjects with nodule and/or tunnel recurrence, as evaluated by treating physician, will be reported.
Shoulder range of motion	Up to 8 weeks	Shoulder range of motion will be measured using a goniometer
Number of dressings used through to healing day	Up to 8 weeks	The number of dressings used through to healing day will be reported
Average pain as assessed by the Numerical Rating Scale (NRS)	Up to 8 weeks	The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Number of subjects with tenderness at surgical sites	Up to 8 weeks	The number of subjects with tenderness at surgical sites, as evaluated by treating physician, will be reported.
Quality of post-surgical scars as measured by the Hurley Stage score	Up to 8 weeks	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)
Amount of exudate at surgical site	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).
Pain after procedure as assessed by the NRS	Day 2 (24 hours post procedure)	The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Days of work lost	Up to 8 weeks	Participants reported days of work lost due to the procedure will be reported
Change in Quality of Life as measured by the DLQI	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
Tissue analysis of microbiome	Up to 8 weeks	As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy and biofilm samples.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States