Clinical Trial

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Recruiting
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Summary
Hidradenitis Suppurativa (HS) is a long-lasting skin condition that causes painful lumps and infections. In severe cases, patients need surgery to remove the affected skin. After surgery, a wound dressing called a wound matrix is placed over the area to help the skin heal. This study will compare two different wound matrices: Restrata®, which is the current standard treatment. Pelashield™ PainGuard™, a newer dressing that contains silver to reduce bacteria and lidocaine to help with pain. The goal of this research is to find out if Pelashield™ PainGuard™ helps patients heal better after surgery than Restrata®. We will look at: How quickly healthy granulation tissue (new healing tissue) forms How soon the wound is ready for the second surgery to apply a skin graft How often infections happen after surgery How much narcotic (opioid) pain medication patients need after surgery Patients who receive Pelashield™ PainGuard™ will be enrolled in the study going forward (prospective group). Patients who previously had surgery with Restrata® will be included through a review of their medical records (retrospective group). No additional procedures will be done outside of standard surgical care.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-31.
Trial Details
NCT Number NCT07316192
Lead Sponsor Rutgers, The State University of New Jersey
Conditions Hidradenitis Suppurativa (HS)
Enrollment 10 participants
Start Date 2025-12-01
Primary Completion 2026-09 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-05-22