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Pelashield™ PainGuard™ vs Restrata® in HS Surgery

RecruitingNAAges 18 Years - anyAllRutgers, The State University of New Jersey
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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).
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What it tests

  • Pelashield Painguard
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Where

1 site
University Hospital
Newark, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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