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Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Key facts

Where
Newark, United StatesSee the site

Where in United States

  • University HospitalNewark, United StatesContact: Mark Granick, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Rutgers, The State University of New Jersey
Trial code
NCT07316192
Record updated
22 May 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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); 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); Active systemic infection or sepsis at time of surgery; Uncontrolled diabetes (most recent HbA1c >10% if available within 3 months); Non-English-speaking patients (due to consent and follow-up communication limitations); Pregnancy or active breastfeeding; Inability to complete postoperative follow-up through second-stage closure (e.g., plans to relocate).

ClinicalTrials.gov NCT07316192