Pelashield™ PainGuard™ vs Restrata® in HS Surgery
ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Pelashield Painguard
DeviceThis is the only intervention being used in this study
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Pelashield™ PainGuard™ GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Opioid Analgesic Usage
Total cumulative opioid consumption during two distinct postoperative periods:
Time frame
Period 1: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) Period 2: Stage 2 closure through 30 days post-Stage 22
ReCell Skin Graft Incorporation
Percentage of the Stage 2 wound bed demonstrating successful ReCell graft take, reflecting the quality of granulation tissue and bacterial burden of the wound bed at time of grafting.
Time frame
Assessment performed at 14 days (±3 days) post-Stage 2 during routine clinic follow-up3
Surgical Site Infection (SSI) During Wound Bed Preparation
Presence of a clinically diagnosed surgical site infection occurring between Stage 1 excision and Stage 2 closure as defined by CDC criteria.
Time frame
After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1)4
Time to Definitive Closure (Granulation Readiness)
Number of days from Stage 1 excision to Stage 2 definitive closure (debridement and ReCell application).
Time frame
After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1)Secondary outcomes
1
Postoperative Non-Opioid Analgesic Use
Time frame
Period 1: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) Period 2: Stage 2 closure through 30 days post-Stage 2Sponsors and contacts
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Source ClinicalTrials.gov