Pelashield PainGuard versus Restrata for healing after HS wide excision

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SPY072 in adults with moderate to severe hidradenitis suppurativa

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  Recruiting at 7 sites Phase 2 Spyre Therapeutics, Inc. · Birmingham, Alabama and 33 other locations · NCT07766005

• Brain activity patterns in people with hidradenitis suppurativa and how treatments may relate to changes

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• Roflumilast 0.3% Foam for Hidradenitis Suppurativa in Teens and Adults

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• Global health study on hidradenitis suppurativa

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.