Pelashield™ PainGuard™ vs Restrata® in HS Surgery
Purpose
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.
Condition
- Hidradenitis Suppurativa (HS)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Newark 5101798, New Jersey 5101760 07103
More Details
- NCT ID
- NCT07316192
- Status
- Recruiting
- Sponsor
- Rutgers, The State University of New Jersey
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.