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Compares treatment options for Hidradenitis Suppurativa (HS)
Official title Pelashield™ PainGuard™ vs Restrata® in HS Surgery
ClinicalTrials.gov ID: NCT07316192
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Pregnancy or active breastfeeding.
- Severe immunosuppression (e.g., chemotherapy within 3 months, solid organ transplant, uncontrolled HIV with CD4 \ 10 mg prednisone-equivalent/day).
- Uncontrolled diabetes (most recent HbA1c \>10% if available within 3 months).
See the full eligibility 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.
- 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 \ 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).
The study team makes the final eligibility decision.
Where it's taking place
- Newark, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.