[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659804":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":15,"studyPopulation":15,"armGroups":37,"interventions":48,"overallOfficials":58,"centralContacts":62,"locations":71,"responsibleParty":88,"collaborators":15,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":15,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":15,"enrollmentInfo":100,"targetDuration":15,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":111,"whyStopped":15,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination by a blinded observer at dressing removal","ACD includes erythema, with or without weeping or pruritus, in a geometric border at the surgical site with absence of fluctuance or purulence","At the time of dressing removal about 10-14 days after surgery",{"measure":14,"description":15,"timeFrame":16},"Number of participants with acute wound dehiscence resulting in reoperation",null,"within 6 weeks of index procedure",[18,22,26],{"measure":19,"description":20,"timeFrame":21},"Clinic utilization as assessed by the the total number of additional patient communications or visits regarding dressings or wound complications.","This will include telephone calls, electronic messages, additional office visits and additional ER visits.","6-8 weeks after the operation",{"measure":23,"description":24,"timeFrame":25},"Patient overall comfort as assessed by question 6 on the Patient Reported Outcomes (PROMs) questionnaire .","This will be measured on a linear scale from 0(very uncomfortable) to 10 (very comfortable), higher number indicating better outcome","2-4 weeks after the operation",{"measure":27,"description":28,"timeFrame":25},"Patient satisfaction with the dressing as assessed by question 7 on the Patient Reported Outcomes (PROMs) questionnaire .","This will be measured on a linear scale from 0(very dissatisfied) to 10 (very satisfied), higher number indicating better outcome",{"allocation":30,"interventionModel":31,"interventionModelDescription":15,"primaryPurpose":32,"observationalModel":15,"timePerspective":15,"maskingInfo":33},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":34,"maskingDescription":15,"whoMasked":35},"SINGLE",[36],"OUTCOMES_ASSESSOR",[38,43],{"label":39,"type":40,"description":15,"interventionNames":41},"Dermabond PRINEO skin closure system","ACTIVE_COMPARATOR",[42],"Device: Dermabond PRINEO",{"label":44,"type":45,"description":15,"interventionNames":46},"Silk fibroin wound dressing","EXPERIMENTAL",[47],"Device: Silk fibroin",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":15},"DEVICE","Dermabond PRINEO","Participants will have the Dermabond PRINEO wound dressing applied after surgery and will undergo standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound. Photos of the surgical wound will be uploaded to the patient's electronic medical record during dressing removal.",[39],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":15},"Silk fibroin","Participants will have the Silk fibroin wound dressing applied after surgery and will undergo standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound. Photos of the surgical wound will be uploaded to the patient's electronic medical record during dressing removal.",[44],[59],{"name":60,"affiliation":5,"role":61},"David Rodriguez-Quintana, MD","PRINCIPAL_INVESTIGATOR",[63,67],{"name":60,"role":64,"phone":65,"phoneExt":15,"email":66},"CONTACT","(713) 486-7500","David.RodriguezQuintana@uth.tmc.edu",{"name":68,"role":64,"phone":69,"phoneExt":15,"email":70},"Ethan Sij","940-399-3314","Ethan.W.Sij@uth.tmc.edu",[72],{"facility":73,"status":15,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"The University of Texas Health Science Center at Houston","Houston","Texas","77479","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-95.36327,29.76328,{"lat":83,"lon":82},[86,87],{"name":60,"role":64,"phone":65,"phoneExt":15,"email":66},{"name":68,"role":64,"phone":69,"phoneExt":15,"email":70},{"type":61,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"David Rodriguez-Quintana","Associate Professor Non-Tenure Clinical","100659804","use-of-silk-fibroin-dressings-in-primary-total-hip-arthroplasty-100659804",false,"NCT07868900","Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty","A Randomized Controlled Trial to Evaluate Wound Complications After Primary Total Hip Arthroplasty Using Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh","Inclusion Criteria:\n\n* primary total hip arthroplasty performed by Dr. Rodriguez, Dr. Freedhand or Dr. Shahi\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":101,"type":102},350,"ESTIMATED","INTERVENTIONAL",[105],"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, to document the incidence of acute wound dehiscence requiring reoperation after application of silk fibroin and 2-octyl cyanoacrylate mesh dressings, 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 after total hip arthroplasty.",[108],"Allergic Contact Dermatitis (ACD)",[110],"total hip arthroplasty","NOT_YET_RECRUITING","2026-10-05",{"date":114,"type":115},"2026-10-09","ACTUAL",{"date":117,"type":102},"2026-10-15",{"date":119,"type":102},"2028-01-01",{"name":5,"class":6},1]