Pelashield™ PainGuard™ vs Restrata® in HS Surgery

May 20, 2026 updated by: Mark Granick, MD, FACS, Rutgers, The State University of New Jersey

Outcomes With Pelashield™ PainGuard™ Compared to Restrata® in Standard Two-Stage Excision and Closure for Hidradenitis Suppurativa: A Prospective Cohort With Retrospective Comparator

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Standard of Care vs. Research:

Wide surgical excision for Hidradenitis Suppurativa at University Hospital follows a standard two-stage approach: excision with wound matrix placement (Stage 1) followed by debridement and definitive closure with ReCell application (Stage 2). Currently, Restrata® wound matrix is our standard of care.

Research Component:

This study compares outcomes between our current standard (Restrata®) and an alternative FDA-cleared wound matrix (Pelashield™ PainGuard™) to determine whether Pelashield is a superior product. The research involves systematic data collection and comparison; all surgical procedures remain University Hospital standard of care.

Wide surgical excision for Hidradenitis Suppurativa following University Hospital's standard of care is often complicated by postoperative pain and poor skin graft adherence due to underlying bacterial overgrowth. Restrata® and Pelashield™ PainGuard™ are both synthetic wound matrices with FDA 510k clearance for use in surgical wounds. Pelashield™ PainGuard™ contains antimicrobial silver and local anesthetic, which may reduce postoperative pain and infection compared to Restrata®, and may provide a cleaner, more robust skin layer for enhanced wound healing and improved adherence of skin grafts. Additionally, the lower cost of Pelashield compared to Restrata aligns with University Hospital's commitment to responsible resource utilization and financial stewardship.

Specific Aim: To evaluate whether Pelashield™ PainGuard™, when used in place of Restrata® for wide excision of hidradenitis suppurativa, results in reduced narcotic pain medication use, reduced time to second procedure, and improved skin graft incorporation at wound site.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Pelashield Painguard
This is the only intervention being used in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Total cumulative opioid consumption during two distinct postoperative periods:
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
Percentage of the Stage 2 wound bed demonstrating successful ReCell graft take, reflecting the quality of granulation tissue and bacterial burden of the wound bed at time of grafting.
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)
Presence of a clinically diagnosed surgical site infection occurring between Stage 1 excision and Stage 2 closure as defined by CDC criteria.
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)
Number of days from Stage 1 excision to Stage 2 definitive closure (debridement and ReCell application).
After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative Non-Opioid Analgesic Use
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Mark Granick, MD, New Jersey Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2025001853

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The findings from this study are intended to contribute to the scientific literature and will likely be disseminated through peer-reviewed publication or presentation at academic meetings. Participants will continue to receive all clinically relevant information about their own care and outcomes during routine follow-up visits, but they will not receive individual or aggregate research results unless they specifically request them after study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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