Stratafix vs. PDS (Fascial Closure RCT)
Starting soon · Not applicable
Conditions studied: Pain Score Reduction, Cesarian Section
In brief
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. Primary 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. Secondary 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).
Key facts
- Study ID
- NCT07574086
- Run by
- University of Arizona
- People needed
- 200
- Starts
- 2026-05-01
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women of reproductive age ( ≥18 years old to ≤ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≥37 weeks of gestation.
You may not qualify if…
- Women of reproductive age (≤ 18 years old to ≥ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≤ 37 weeks of gestation.
- Emergent Cesarean delivery
- Chronic opioid use or pain disorders
- Allergy to suture materials
- Previous classical Cesarean section
- Intraoperative complications (e.g. hemorrhage, uterine rupture, injury)
Full record on ClinicalTrials.gov
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