A Bioelectric Dressing for Post De-Roofing Treatment of HS

Not Applicable

Active, not recruiting

• Conditions: Hidradenitis Suppurativa

• 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

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