Pelashield™ PainGuard™ vs Restrata® in HS Surgery
Recruiting now · Not applicable
Conditions studied: Hidradenitis Suppurativa (HS)
In brief
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.
Key facts
- Study ID
- NCT07316192
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 10
- Starts
- 2025-12-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- University Hospital — Newark, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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