[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649287":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pelashield","EXPERIMENTAL","Pelashield skin graft dressing",[13],"Device: Pelashield",{"label":15,"type":16,"description":17,"interventionNames":18},"Xeroform","ACTIVE_COMPARATOR","standard of care skin graft dressing",[19],"Device: Xeroform",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Pelashield dressing will be applied to half of the skin graft donor site",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Xeroform dressing will be applied to have of the skin graft donor site",[15],[30],{"name":31,"affiliation":32,"role":33},"John K. Bailey, MD","Atrium Health Wake Forest Baptist","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"D'Ann Hershel","CONTACT","336-716-1659","dann.hershel@advocatehealth.org",[41],{"facility":32,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Winston-Salem","North Carolina","27157","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-80.24422,36.09986,{"lat":51,"lon":50},[54],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100649287","phase-4-pelashield-vs-xeroform-100649287",false,"NCT07734519","Pelashield vs Xeroform","A Prospective Randomized Split-Site Study of Donor-Site Pain and Appearance Following Pelashield TM Versus Xeroform","Inclusion Criteria:\n\n* Undergoing split-thickness skin graft harvest, with a donor site sufficiently large to allow division into two comparable halves for randomized dressing application.\n* Donor site located in an area amenable to standardized photography and serial appearance assessment.\n* Ability to provide informed consent.\n* Willingness and ability to participate in scheduled follow-up visits for donor-site assessment, including standardized photography.\n* Donor-site management expected to follow the standardized study dressing protocol for the duration of the early healing period.\n\nExclusion Criteria:\n\n* Inability, or anticipated inability, to reliably report pain within 1hour (or in recovery room) after surgery\n* Known allergy or hypersensitivity to lidocaine, silver-containing dressings, or other components of the study dressings.\n* Donor sites that are too small, irregularly shaped, or anatomically unsuitable to allow division into two comparable treatment halves.\n* Pre-existing skin disease at or adjacent to the donor-site region that may affect wound healing or scar appearance\n* Clinical situations in which the treating surgeon anticipates that protocol-based donor-site care cannot be maintained, including cases requiring non-standard dressings or adjunctive local therapies.\n* Anticipated inability to complete follow-up assessments, including inability to obtain evaluable standardized photographs at key time points.\n* Severe uncontrolled systemic conditions likely to significantly impair wound healing, at the discretion of the investigator (e.g., severe immunosuppression or other conditions making reliable donor-site healing unlikely).\n* Allergy to any local anesthetic\n* Allergy or sensitivity to silver\n* Pregnancy","ALL","18 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","The purpose of this research study is to compare the effects (good or bad) of a new skin graft dressing (PelashieldTM) compared to the one traditionally used (Xeroform).",[74],"Skin Graft",[9,15,76],"donor site pain","NOT_YET_RECRUITING","2026-07-29",{"date":80,"type":81},"2026-07-31","ACTUAL",{"date":83,"type":68},"2026-08",{"date":85,"type":68},"2027-07",{"name":5,"class":6},1]