NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery
| NCT ID | NCT07316192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Hidradenitis Suppurativa (HS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-12-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
Mark Granick, MD
PRINCIPAL INVESTIGATOR
New Jersey Medical School
Frequently Asked Questions
Who can join the NCT07316192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hidradenitis Suppurativa (HS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07316192 currently recruiting?
Yes, NCT07316192 is actively recruiting participants. Contact the research team at nr564@njms.rutgers.edu for enrollment information.
Where is the NCT07316192 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT07316192 clinical trial?
NCT07316192 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Mark Granick, MD at New Jersey Medical School. The trial plans to enroll 10 participants.