RecruitingNot ApplicableNCT07316192

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Outcomes With Pelashield™ PainGuard™ Compared to Restrata® in Standard Two-Stage Excision and Closure for Hidradenitis Suppurativa: A Prospective Cohort With Retrospective Comparator

Sponsor

Rutgers, The State University of New Jersey

Enrollment

10 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Hidradenitis Suppurativa (HS)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Adults (≥18 years) with a confirmed clinical diagnosis of HS requiring wide surgical excision.
Ability to provide informed consent in English.
Willingness and ability to attend routine postoperative follow-up visits to monitor healing and readiness for second-stage closure.

Exclusion Criteria8

Non-English-speaking patients (due to consent and follow-up communication limitations).
Known allergy or hypersensitivity to wound matrix components (polyvinyl alcohol), local anesthetics, or silver.
Known sensitivity to lidocaine or history of cardiac conditions contraindicating lidocaine use (e.g., severe heart block, Adams-Stokes syndrome, Wolff-Parkinson-White syndrome).
Pregnancy or active breastfeeding.
Severe immunosuppression (e.g., chemotherapy within 3 months, solid organ transplant, uncontrolled HIV with CD4 <200, or chronic systemic steroids >10 mg prednisone-equivalent/day).
Uncontrolled diabetes (most recent HbA1c >10% if available within 3 months).
Active systemic infection or sepsis at time of surgery.
Inability to complete postoperative follow-up through second-stage closure (e.g., plans to relocate).