Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Official title

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

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.

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.

Interventions

• Device Pelashield Painguard
  This is the only intervention being used in this study

Primary outcome measures

• 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)]

Secondary outcome measures (1)

• 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]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University Hospital — Newark

Publications

• Leaper DJ, Schultz G, Carville K, Fletcher J, Swanson T, Drake R. Extending the TIME concept: what have we learned in the past 10 years?(*). Int Wound J. 2012 Dec;9 Suppl 2(Suppl 2):1-19. doi: 10.1111/j.1742-481X.2012.01097.x. PMID 23145905
• Wounds UK. International consensus. Appropriate use of silver dressings in wounds. Wounds UK. 2012;8(1):1-28.
• MacEwan MR, MacEwan S, Kovacs TR, Batts J. What Makes the Optimal Wound Healing Material? A Review of Current Science and Introduction of a Synthetic Nanofabricated Wound Care Scaffold. Cureus. 2017 Oct 2;9(10):e1736. doi: 10.7759/cureus.1736. PMID 29209583
• Matusiak L, Bieniek A, Szepietowski JC. Psychophysical aspects of hidradenitis suppurativa. Acta Derm Venereol. 2010 May;90(3):264-8. doi: 10.2340/00015555-0866. PMID 20526543
• Ring HC, Sorensen H, Miller IM, List EK, Saunte DM, Jemec GB. Pain in Hidradenitis Suppurativa: A Pilot Study. Acta Derm Venereol. 2016 May;96(4):554-6. doi: 10.2340/00015555-2308. No abstract available. PMID 26631388
• Scuderi N, Alfano C, Paolini G, et al. Surgical treatment of hidradenitis suppurativa: evaluation of two methods and postoperative outcome analysis. Int Wound J. 2013;10(4):435-441.
• Kohorst JJ, Baum CL, Otley CC, Roenigk RK, Schenck LA, Pemberton JH, Dozois EJ, Tran NV, Senchenkov A, Davis MD. Surgical Management of Hidradenitis Suppurativa: Outcomes of 590 Consecutive Patients. Dermatol Surg. 2016 Sep;42(9):1030-40. doi: 10.1097/DSS.0000000000000806. PMID 27340739
• Alavi A, Lynde C, Alhusayen R, Bourcier M, Delorme I, George R, Gooderham M, Gulliver W, Kalia S, Marcoux D, Poulin Y. Approach to the Management of Patients With Hidradenitis Suppurativa: A Consensus Document. J Cutan Med Surg. 2017 Nov/Dec;21(6):513-524. doi: 10.1177/1203475417716117. Epub 2017 Jun 22. PMID 28639459

Identifiers

NCT: NCT07316192 · Pro2025001853

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗