Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07316192

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Led by Rutgers, The State University of New Jersey · Updated on 2026-01-05

10

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (18 years or older) with a confirmed diagnosis of Hidradenitis Suppurativa 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
Not Eligible

You will not qualify if you...

  • Non-English-speaking patients
  • Allergy or hypersensitivity to wound matrix components (polyvinyl alcohol), local anesthetics, or silver
  • Sensitivity to lidocaine or history of cardiac conditions that contraindicate lidocaine use (e.g., severe heart block, Adams-Stokes syndrome, Wolff-Parkinson-White syndrome)
  • Pregnancy or active breastfeeding
  • Severe immunosuppression (such as 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% within 3 months if available)
  • Active systemic infection or sepsis at time of surgery
  • Inability to complete postoperative follow-up through second-stage closure (e.g., plans to relocate)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital

Newark, New Jersey, United States, 07103

Actively Recruiting

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Research Team

N

Neil Reddy, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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