[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637016":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":26,"id":64,"slug":26,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SYLKE® Adhesive Wound Closure","EXPERIMENTAL","SYLKE Adhesive Wound Closure is a premium, sterile surgical dressing made from 99.9% medical-grade silk fibroin, designed to approximate and secure wound edges for up to 14 days.",[13],"Device: Silk fibroin (SYLKE)",{"label":15,"type":16,"description":17,"interventionNames":18},"DERMABOND™ PRINEO™ Skin Closure System","ACTIVE_COMPARATOR","The DERMABOND™ PRINEO™ Skin Closure System is a two-part, topical, sterile medical device used to close surgical incisions and lacerations, combining a 2-octyl cyanoacrylate liquid adhesive with a self-adhering polyester mesh.",[19],"Device: 2-octyl cyanoacrylate mesh (Dermabond PRINEO)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Silk fibroin (SYLKE)","SYLKE dressing will be placed in a sealed envelope, which will be opened by the operative surgeon during wound closure and placed on the closed wound. 2 week and 6 week postoperative appointments will include a standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"2-octyl cyanoacrylate mesh (Dermabond PRINEO)","Dermabond PRINEO dressing will be placed in a sealed envelope, which will be opened by the operative surgeon during wound closure and placed on the closed wound. 2 week and 6 week postoperative appointments will include a standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound.",[15],[32],{"name":33,"affiliation":5,"role":34},"James M Gregory, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","(713) 486-7500","James.M.Gregory@uth.tmc.edu",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Matthew Smith, MD","(713) 486-6536","Matthew.Smith@uth.tmc.edu",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-95.36327,29.76328,{"lat":56,"lon":55},[59,60],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},{"type":34,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"James M. Gregory","Associate Professor","100637016",false,"NCT07573202","Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery","Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh a Randomized Controlled Trial to Evaluate Hypersensitivity Reactions in Shoulder Surgery","Inclusion Criteria:\n\n* open shoulder procedure with Dr. James Gregory or Dr. Robert Fullick.\n\nExclusion Criteria:\n\n* Prior documented medical adhesive contact allergy.\n* Negative pressure wound dressings.\n* Any procedure involving a wound problem at the planned surgical site.","ALL","18 Years",{"count":73,"type":74},350,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this study is to document the incidence of allergic contact dermatitis (ACD) to silk fibroin and 2-octyl cyanoacrylate mesh dressings after open shoulder surgery, to identify differences in clinic utilization for complications related to silk fibroin and 2-octyl cyanoacrylate mesh dressings and to collect patient reported outcome measures (PROMs) related to patient comfort and satisfaction for silk fibroin and 2-octyl cyanoacrylate mesh dressings.",[80,81],"Hypersensitivity Reactions","Allergic Contact Dermatitis",[83,28,84,85,86],"silk fibroin (SYLKE)","open shoulder surgery","hypersensitivity","contact dermatitis","NOT_YET_RECRUITING","2026-05-11",{"date":90,"type":91},"2026-05-14","ACTUAL",{"date":93,"type":74},"2026-06-30",{"date":95,"type":74},"2028-07-30",{"name":5,"class":6},1]