Outcomes With Pelashield™ PainGuard™ Compared to Restrata® in Standard Two-Stage Excision and Closure for Hidradenitis Suppurativa: A Prospective Cohort With Retrospective Comparator
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Postoperative Opioid Analgesic Usage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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
干预措施: Pelashield Painguard (Device)
结局指标
主要结局
Postoperative Opioid Analgesic Usage
时间窗: 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:
ReCell Skin Graft Incorporation
时间窗: 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.
Surgical Site Infection (SSI) During Wound Bed Preparation
时间窗: 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.
Time to Definitive Closure (Granulation Readiness)
时间窗: 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).
次要结局
- Postoperative Non-Opioid Analgesic Use(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)
研究者
Mark Granick, MD, FACS
MD
Rutgers, The State University of New Jersey