[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617251":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pelashield™ PainGuard™ Group","EXPERIMENTAL","Procedures:\n\nPerform wide excision of HS-affected tissue Apply Pelashield™ PainGuard™ to cover the surgical wound Place wound dressing and provide standard postoperative care instructions",[13],"Device: Pelashield Painguard",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Pelashield Painguard","This is the only intervention being used in this study",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Mark Granick, MD","New Jersey Medical School","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Neil Reddy, BS","CONTACT","732-604-5296","nr564@njms.rutgers.edu",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University Hospital","RECRUITING","Newark","New Jersey","07103","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-74.17237,40.73566,{"lat":45,"lon":44},[48,51],{"name":23,"role":29,"phone":49,"phoneExt":20,"email":50},"973-972-5377","granickm@njms.rutgers.edu",{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"type":25,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Mark Granick, MD, FACS","MD","100617251","pelashield-painguard-vs-restrata-in-hs-surgery-100617251",false,"NCT07316192","Pelashield™ PainGuard™ vs Restrata® in HS Surgery","Outcomes With Pelashield™ PainGuard™ Compared to Restrata® in Standard Two-Stage Excision and Closure for Hidradenitis Suppurativa: A Prospective Cohort With Retrospective Comparator","Inclusion Criteria:\n\n* Adults (≥18 years) with a confirmed clinical diagnosis of HS requiring wide surgical excision.\n* Ability to provide informed consent in English.\n* Willingness and ability to attend routine postoperative follow-up visits to monitor healing and readiness for second-stage closure.\n\nExclusion Criteria:\n\n* Non-English-speaking patients (due to consent and follow-up communication limitations).\n* Known allergy or hypersensitivity to wound matrix components (polyvinyl alcohol), local anesthetics, or silver.\n* Known sensitivity to lidocaine or history of cardiac conditions contraindicating lidocaine use (e.g., severe heart block, Adams-Stokes syndrome, Wolff-Parkinson-White syndrome).\n* Pregnancy or active breastfeeding.\n* Severe immunosuppression (e.g., chemotherapy within 3 months, solid organ transplant, uncontrolled HIV with CD4 \\\u003C200, or chronic systemic steroids \\>10 mg prednisone-equivalent\u002Fday).\n* Uncontrolled diabetes (most recent HbA1c \\>10% if available within 3 months).\n* Active systemic infection or sepsis at time of surgery.\n* Inability to complete postoperative follow-up through second-stage closure (e.g., plans to relocate).","ALL","18 Years",{"count":65,"type":66},10,"ESTIMATED","INTERVENTIONAL",[69],"NA","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.\n\nThis study will compare two different wound matrices:\n\nRestrata®, which is the current standard treatment. Pelashield™ PainGuard™, a newer dressing that contains silver to reduce bacteria and lidocaine to help with pain.\n\nThe goal of this research is to find out if Pelashield™ PainGuard™ helps patients heal better after surgery than Restrata®. We will look at:\n\nHow 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.",[72],"Hidradenitis Suppurativa (HS)",[74,75,76],"Prospective","Wide local Excision","Wound Healing","2026-05-20",{"date":79,"type":80},"2026-05-22","ACTUAL",{"date":82,"type":80},"2025-12-01",{"date":84,"type":66},"2026-11",{"name":5,"class":6},1]