Recruiting

Pelashield™ PainGuard™ vs. Restrata®

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07316192

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelashield Painguard

Study Details

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.

Conditions

Hidradenitis Suppurativa (HS)

Study ID

NCT07316192

Start date

Dec 1, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pelashield™ PainGuard™ Group

Procedures:

Perform wide excision of HS-affected tissue Apply Pelashield™ PainGuard™ to cover the surgical wound Place wound dressing and provide standard postoperative care instructions

Interventions

Pelashield Painguard

This is the only intervention being used in this study

Primary outcome measure

  • Postoperative Opioid Analgesic Usage [ Time Frame: Period 1: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) Period 2: Stage 2 closure through 30 days post-Stage 2 ]
  • ReCell Skin Graft Incorporation [ Time Frame: Assessment performed at 14 days (±3 days) post-Stage 2 during routine clinic follow-up ]
  • Surgical Site Infection (SSI) During Wound Bed Preparation [ Time Frame: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) ]
  • Time to Definitive Closure (Granulation Readiness) [ Time Frame: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) ]

Central Contacts and Locations

Central contacts

Neil Reddy, BS

732-604-5296nr564@njms.rutgers.edu

Locations

University Hospital

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Mark Granick, MD

973-972-5377granickm@njms.rutgers.edu

Neil Reddy, BS

732-604-5296nr564@njms.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

May 22, 2026

Last verified

Apr, 2026

Keywords

  • Prospective
  • Wide local Excision
  • Wound Healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-05-22.