Pelashield™ PainGuard™ vs Restrata® in HS Surgery

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.

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).