Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Rutgers, The State University of New Jersey10 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Postoperative Opioid Analgesic Usage

Total cumulative opioid consumption during two distinct postoperative periods:

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

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.

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

Presence of a clinically diagnosed surgical site infection occurring between Stage 1 excision and Stage 2 closure as defined by CDC criteria.

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)

Number of days from Stage 1 excision to Stage 2 definitive closure (debridement and ReCell application).

Time frame: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1)

Secondary Outcomes

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

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts