Barbed Suture for Hysterotomy Closure During Cesarean Section

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2024-01-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hysterotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned to either the treatment arm or control arm of the study prior to commencement of the cesarean section and following informed consent. Allocation will be concealed to all researchers/providers until this point. The patients will be randomly allocated by block randomization. Generation of random sequence will be done by independent personnel, usually a statistician, who is not going to be involved in the conduct of the RCT. The access to this sequence should be restricted to only a few individuals who absolutely need to have access.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard suture

Standard antimicrobial suture (vicryl) - control arm

Group Type ACTIVE_COMPARATOR

Standard antimicrobial suture

Intervention Type PROCEDURE

to close a C-section incision

Barbed suture

Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue

Group Type EXPERIMENTAL

Barbed suture

Intervention Type DEVICE

to close a C-section incision

Interventions

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Barbed suture

to close a C-section incision

Intervention Type DEVICE

Standard antimicrobial suture

to close a C-section incision

Intervention Type PROCEDURE

Other Intervention Names

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STRATAFIX Symmetric PDS Plus Knotless Tissue vicryl

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes