Barbed Suture for Hysterotomy Closure During Cesarean Section

Not Applicable

Completed

Interventions: Procedure: Standard antimicrobial suture
Device: Barbed suture

Brief Summary: This is a randomized controlled trial. The purpose of this study is to see if patients whose uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with barbed suture, have less blood loss compared to women whose incision is closed with the standard suture (vicryl). The primary outcome is quantification of blood loss (QBL). Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.

Study participation will last 1 year and will include the following research procedures :

1. Randomization to barbed suture vs. standard suture

2. Collection of data for primary and secondary outcomes

3. Telephone survey 2 weeks following the procedure to assess pain, bowel/bladder habits, and evidence of wound infection. The barbed suture is approved by the FDA for use in soft tissue approximation and this is not an off-label usage.

Detailed Description: This is a prospective, randomized controlled trial (RCT) evaluating whether using a barbed suture to close a C-section incision can reduce blood loss. Patients undergoing C-section will be randomized with equal allocation to a barbed suture or a standard antimicrobial suture. The primary outcome is quantification of blood loss (QBL). Differences between the groups will be assessed using a 0.05 level Wilcoxon rank-sum test. Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis/SSI (superficial wound infection, deep wound infection, and endometritis) within 6 weeks postpartum, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.

Recruitment & Eligibility

Inclusion Criteria

All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital
age 18-64.

Exclusion Criteria

Multifetal gestations
Placenta previas
Pre-term patients
Patients with prior uterine incisions or a coagulopathy (DIC, Von Willebrands Disease, etc)
Patients undergoing an unplanned or emergency cesarean section

Arm && Interventions

Group	Intervention	Description
Standard suture	Standard antimicrobial suture	Standard antimicrobial suture (vicryl) - control arm
Barbed suture	Barbed suture	Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue

Primary Outcome Measures

Name	Time	Method
Quantitative Blood Loss	Day 1, At delivery	Quantification of blood loss (QBL)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Need Additional Hemostatic Sutures	Day 1, At delivery
Number of Hemostatic Sutures	Day 1, At delivery	Number of hemostatic sutures needed during procedure
Rate of Surgical Site Infections (SSI)	6 weeks	Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)
Time for Hysterotomy Closure	Day 1, At delivery	Time for hysterotomy closure
Number of Participants With Surgical Site Infections (SSI)	Day 1, At delivery	Number of Participants to assess rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)
Change in Pain Score	Day 1, At delivery and 2 weeks	Change in pain score at 2 weeks from baseline. Pain score from 0 to 10, with higher score indicating more pain. Follow up pain assessment by a telephone screening 2 weeks following delivery.