Stratafix vs Vicryl suture for hysterotomy closure in scheduled cesarean deliveries: a randomized clinical trial.
Academic Article
Overview
abstract
BACKGROUND: Reducing blood loss at the time of scheduled cesarean improves maternal outcomes. Type of suture material and closure technique may contribute to reduction in blood loss specifically related to the incision site as well as more expeditiously achieve uterine contractility. Prior publications have noted reduced closure times when using knotless barbed suture, but available evidence remains limited. OBJECTIVE: To examine whether patients whose hysterotomies were closed with Stratafix barbed suture at the time of scheduled cesarean delivery had lower quantified blood loss compared to patients who received Vicryl (Polyglactin 910) suture. STUDY DESIGN: This was a prospective randomized clinical trial at a single tertiary care center in New York City. Patients with a scheduled primary or repeat cesarean delivery ≥37.0 weeks' gestation provided informed consent and were randomized to either Stratafix barbed suture or Vicryl (Polyglactin 910) suture for hysterotomy closure. The primary outcome was quantified blood loss, measured in milliliters using the mobile Stryker Triton artificial intelligence scanner. Secondary outcomes included (1) single-layer hysterotomy closure time, (2) use of additional hemostatic sutures, (3) intraoperative use of hemostatic agents, (4) rate of surgical site infection (including endometritis), and (5) differences in average postoperative pain. The Mann-Whitney U test compared observed medians of continuous outcomes between groups. Chi-squared tests compared proportional differences in categorical outcomes between groups. An a posteriori multivariable quantile regression model examined whether continuous outcomes differed when controlling for suspected confounders. RESULTS: Between July 20, 2021 and November 30, 2023, 226 patients were randomized to either Stratafix barbed suture (n=113) or Vicryl (Polyglactin 910) suture (n=113) at the time of scheduled cesarean delivery. We observed no significant difference between the median quantified blood loss observed in the Stratafix barbed suture group (544.5 [250.7-838.8] mL) and the Vicryl (Polyglactin 910) suture group (600 [348-852] mL; P=.22). Median time to hysterotomy closure was 1.3 minutes shorter in the Stratafix barbed suture group (4.1[2.6-5.6] minutes) and the Vicryl (Polyglactin 910) suture group (5.4 [3.5-7.2] minutes; P<.001). In an a posteriori multivariable quantile regression adjusting for confounders, the median total quantified blood loss was not statistically significantly different between groups (P=.37). Median time to hysterotomy closure was 1.8 minutes shorter for the Stratafix barbed suture group (P<.01). CONCLUSION: The use of Stratafix barbed sutures was not associated with a reduction in blood loss compared with the Vicryl (Polyglactin 910) suture. However, the results of this randomized clinical trial suggest that Stratafix barbed suture may be associated with faster single-layer hysterotomy closure time. This suggests that Stratafix barbed suture could have benefits over Vicryl (Polyglactin 910) suture for the single-layer closure of hysterotomy during cesarean delivery. Any possible benefits of using Stratafix barbed suture at the time of hysterotomy closure during scheduled cesarean require further exploration.
