Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07316192

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

Led by Rutgers, The State University of New Jersey · Updated on 2026-05-22

10

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hidradenitis Suppurativa (HS) is a chronic skin condition characterized by painful lumps and infections that sometimes require surgical removal of affected skin. This research compares two wound dressings used after surgery: the standard Restrata4 wound matrix and a newer Pelashield20 PainGuard20 dressing that contains silver to reduce bacteria and lidocaine to help control pain. The goal is to see if Pelashield20 PainGuard20 improves healing, reduces infection, and lowers the need for opioid pain medication compared to Restrata4. The study involves a standard two-stage surgical approach where wide excision of HS-affected skin is performed followed by placement of a wound matrix to cover the surgical wound. The Pelashield20 PainGuard20 dressing is applied during the first surgery as an investigational intervention. Patients receiving Pelashield20 will be followed prospectively, while past patients treated with Restrata4 will be included retrospectively by reviewing their medical records. All surgical and postoperative care follows the hospital's standard protocols. Participants will be monitored through routine clinic visits to assess wound healing, pain medication use, infection rates, and readiness for the second surgery involving skin graft application. Key outcomes measured include opioid use after surgery, skin graft incorporation at about two weeks after the second surgery, infection during wound preparation, and time until the wound is ready for closure. The study plans to track these outcomes up to 8 weeks after the first surgery and 30 days following the second procedure.

CONDITIONS

Brief Title

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (18 years or older) with a confirmed diagnosis of Hidradenitis Suppurativa 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
Not Eligible

You will not qualify if you...

  • Non-English-speaking patients
  • Known allergy or hypersensitivity to wound matrix components, 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., recent chemotherapy, organ transplant, uncontrolled HIV with low CD4 count, or high-dose steroids)
  • Uncontrolled diabetes with recent HbA1c over 10%
  • Active systemic infection or sepsis at time of surgery
  • Inability to complete postoperative follow-up through second-stage closure (e.g., plans to relocate)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day 1

Participants undergo wide surgical excision of hidradenitis suppurativa-affected tissue followed by application of the Pelashield™ PainGuard™ wound matrix and receive standard postoperative care instructions.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 8 weeks after Stage 1 surgery

Participants are monitored up to 8 weeks after the first surgery to assess wound healing, narcotic and non-opioid pain medication use, surgical site infection, and readiness for second-stage closure.

Weekly visits for up to 8 weeks

Surgery and Immediate Post-operative Care

Duration - Day of Stage 2 surgery

Participants undergo the second-stage procedure involving debridement and definitive closure with ReCell skin graft application.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 30 days post Stage 2 surgery

Participants are monitored for 30 days after the second-stage surgery to evaluate skin graft incorporation and post-operative pain medication use.

1 follow-up visit at about 14 days and additional visits as needed

Trial Site Locations

Total: 1 location

1

University Hospital

Newark, New Jersey, United States, 07103

Actively Recruiting

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Research Team

N

Neil Reddy, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

What Makes the Optimal Wound Healing Material? A Review of Current Science and Introduction of a Synthetic Nanofabricated Wound Care Scaffold.

Matthew R MacEwan, Sarah MacEwan, Tamas R Kovacs...

https://pubmed.ncbi.nlm.nih.gov/29209583