A Bioelectric Dressing for Post De-Roofing Treatment of HS

University of Miami

Status: Active, not recruiting

Conditions: Hidradenitis Suppurativa

Treatments: Other: Standard Gauze Dressing; Device: Procellera Bioelectric Dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05057429

20210621

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left Armpit

Experimental group

Description:

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.

Treatment:

Device: Procellera Bioelectric Dressing

Other: Standard Gauze Dressing

Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right Armpit

Experimental group

Description:

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.

Treatment:

Device: Procellera Bioelectric Dressing

Other: Standard Gauze Dressing