Pelashield PainGuard versus Restrata for healing after HS wide excision
Outcomes With Pelashield™ PainGuard™ Compared to Restrata® in Standard Two-Stage Excision and Closure for Hidradenitis Suppurativa: A Prospective Cohort With Retrospective Comparator
This research will test whether the Pelashield PainGuard dressing helps adults having wide excision for hidradenitis suppurativa heal faster and need less opioid pain medicine than the standard Restrata dressing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Newark, New Jersey) |
| Trial ID | NCT07316192 on ClinicalTrials.gov |
What this trial studies
This single-center interventional comparison enrolls adults undergoing the standard two-stage wide excision approach for hidradenitis suppurativa at University Hospital (Stage 1: excision with wound matrix, Stage 2: debridement and ReCell closure). Patients receiving the Pelashield PainGuard wound matrix will be prospectively followed and compared to outcomes with the current standard Restrata matrix. Key outcomes include time to healthy granulation tissue, readiness for second-stage skin grafting, postoperative infection rates, and opioid analgesic consumption. All procedures follow usual clinical care while standardized data collection is used to compare the two FDA 510(k)-cleared matrices.
Who should consider this trial
Good fit: Adults (≥18) with clinically confirmed hidradenitis suppurativa requiring wide surgical excision who can consent in English and attend postoperative follow-up visits are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have known allergies to silver, lidocaine, or matrix components, have severe immunosuppression, uncontrolled diabetes, or cardiac contraindications to lidocaine are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, Pelashield PainGuard could speed wound healing, reduce infections and opioid use after HS surgery, improve graft take, and lower treatment costs.
How similar studies have performed: Antimicrobial and analgesic dressings have shown benefits for reducing infection and pain in other wound types, but a direct head-to-head comparison of these specific matrices after HS wide excision is novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Newark, New Jersey
- University Hospital — Newark, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Mark Granick, MD — New Jersey Medical School
- Study coordinator: Neil Reddy, BS
- Email: nr564@njms.rutgers.edu
- Phone: 732-604-5296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.