Barbed Suture for Hysterotomy Closure During Cesarean Section

Mount Sinai Health System

Status: Completed

Conditions: Hysterotomy

Treatments: Procedure: Standard antimicrobial suture; Device: Barbed suture

Study type: Interventional

Funder types: Other

Identifiers

NCT04622267

GCO 20-2571

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Standard suture

Active Comparator group

Description:

Standard antimicrobial suture (vicryl) - control arm

Treatment:

Procedure: Standard antimicrobial suture

Barbed suture

Experimental group

Description:

Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue

Treatment:

Device: Barbed suture