Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section

Not Applicable

Completed

• Conditions: Hysterotomy Closure
• Interventions: Procedure: Stratafix synthetic barbed suture

• Registration Number: NCT02517710
• Lead Sponsor: Evangelical Community Hospital, Lewisburg, PA

Brief Summary

Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.

Detailed Description

Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-07
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.

Exclusion Criteria

• General Anesthesia
• Non-consent to participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Stratafix synthetic barbed suture	Group of patients receiving standard hysterotomy closure with synthetic braided suture
Stratfix	Stratafix synthetic barbed suture	group of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain

Primary Outcome Measures

Name	Time	Method
Blood loss in closure with barbed synthetic suture	2 days	monitoring of preoperative and postoperative hemoglobin and hematcrit

Secondary Outcome Measures

Name	Time	Method
Post operative pain after cesarean secton	3 days	using visual analog pain scale, compare standard closure to barbed suture closure pain

Trial Locations

Locations (1)

Evangelical Community Hospital; 🇺🇸 Lewisburg, Pennsylvania, United States