Pelashield™ PainGuard™ vs Restrata® in HS Surgery (NCT07316192)
Outcomes With Pelashield™ PainGuard™ Compared to Restrata® in Standard Two-Stage Excision and Closure for Hidradenitis Suppurativa: A Prospective Cohort With Retrospective Comparator
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University Hospital — Newark, New Jersey
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University Hospital — Newark, New Jersey
📞 Contact the Study Coordinator
Phone: (732) 604-5296
Email: nr564@njms.rutgers.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hidradenitis Suppurativa (HS)
- Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense — Phoenix, Arizona
- A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa — Phoenix, Arizona
- Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa — Missouri City, Texas
- A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial) — Irvine, California
- A Study to Evaluate the Efficacy of Botulinum Toxin in Patients With Hidradenitis Suppurativa — Worcester, Massachusetts
- ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa — Chapel Hill, North Carolina
Explore by condition: All Hidradenitis Suppurativa (HS) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.