Hidradenitis Suppurativa Clinical Trials

Find Hidradenitis Suppurativa Clinical Trials Near You

Outcomes With Pelashield™ PainGuard™ Compared to Restrata® in Standard Two-Stage Excision and Closure for Hidradenitis Suppurativa: A Prospective Cohort With Retrospective Comparator

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
University Hospital
RECRUITING
Newark
Contact Information
Primary
Neil Reddy, BS
nr564@njms.rutgers.edu
732-604-5296
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 10
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov