[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640393":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":24,"responsibleParty":43,"collaborators":24,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":24,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":24,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":24},{"fullName":5,"class":6},"University of Arizona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PDS","ACTIVE_COMPARATOR","Polydioxanone",[13],"Device: Polydioxanone (PDS)",{"label":15,"type":10,"description":16,"interventionNames":17},"Stratafix","Polydioxanone Plus",[18],"Device: Polydioxanone Plus",[20,25],{"type":21,"name":16,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Polydioxanone Plus (PDS) is a standard monofilament, absorbable suture used for fascial closure at the time of Cesarean delivery. In this study, PDS will be used to approximate the rectus fascia in a continuous running fashion with a traditional terminal knot. This intervention represents the conventional method of fascial closure and serves as the control arm for comparison against Stratafix barbed suture",[15],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Polydioxanone (PDS)","Polydioxanone (PDS) is a standard monofilament, absorbable suture used for fascial closure at the time of Cesarean delivery. In this study, PDS will be used to approximate the rectus fascia in a continuous running fashion with a traditional terminal knot. This intervention represents the conventional method of fascial closure and serves as the control arm for comparison against Stratafix barbed suture.",[9],[30],{"name":31,"affiliation":5,"role":32},"Kathleen Curley, MD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Anna Valencia, MPH","CONTACT","520-780-8241","atvalencia@email.arizona.edu",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Stephanie Marsh Marsh, MPH","602-255-7552","slmarsh@email.arizona.edu",{"type":32,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Kathleen Curley","Principal Investigator","100640393","stratafix-vs-pds-fascial-closure-rct-100640393",false,"NCT07574086","Stratafix vs. PDS (Fascial Closure RCT)","A Randomized Controlled Trial Comparing Stratafix vs. PDS Suture for Fascial Closure at Cesarean Delivery: Impact on Postoperative Pain and Narcotic Use","Inclusion Criteria:\n\n* Women of reproductive age ( ≥18 years old to ≤ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≥37 weeks of gestation.\n\nExclusion Criteria:\n\n* Women of reproductive age (≤ 18 years old to ≥ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≤ 37 weeks of gestation.\n* Emergent Cesarean delivery\n* Chronic opioid use or pain disorders\n* Allergy to suture materials\n* Previous classical Cesarean section\n* Intraoperative complications (e.g. hemorrhage, uterine rupture, injury)",true,"FEMALE","18 Years","45 Years",{"count":58,"type":59},200,"ESTIMATED","INTERVENTIONAL",[62],"NA","This proposed prospective, randomized, single-blinded controlled trial will directly compare Stratafix anti-microbial barbed sutures and standard PDS sutures for fascial closure at the time of Cesarean delivery.\n\nPrimary outcomes will include postoperative pain scores at 24 hours, 48 hours, and two weeks postpartum (both total pain and right-sided abdominal pain commonly associated with the knot from traditional fascial closure), as well as total opioid consumption (morphine milligram equivalents) for the first 48 hours.\n\nSecondary outcomes will include length of hospital stay, wound complications (e.g., infection, dehiscence), patient satisfaction measured per the standardized surgical satisfaction questionnaire (SSQ-8), time required for fascial closure (minutes from start to end of fascial closure), and surgical site infections. The hypothesis is that among women undergoing primary Cesarean delivery, fascial closure with barbed suture (Stratafix) will result in lower postoperative pain scores and reduced opioid (narcotic) consumption within the first 48 hours after surgery compared to closure with traditional monofilament suture (PDS).",[65,66],"Pain Score Reduction","Cesarian Section",[66,65,68],"Opiod use","NOT_YET_RECRUITING","2026-05-01",{"date":72,"type":73},"2026-05-07","ACTUAL",{"date":70,"type":59},{"date":76,"type":59},"2031-12-31",{"name":5,"class":6}]