Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean Section

Not Applicable

• Conditions: Cesarean Section
• Interventions: Device: Barbed suture ( STRATAFIX™ ); Device: Conventional suture (VICRYL™)

• Registration Number: NCT03183362
• Lead Sponsor: Cairo University

Brief Summary

The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with more postoperative adhesions compared with conventional sutures or not.

Detailed Description

The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with an increase in the rate of postoperative adhesions compared with conventional sutures or not. Primigravida patients undergoing transverse lower segment cesarean section will be included in the study.Cesarean section incision will be closed with double layers of continuous barbed or conventional sutures.Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14
• Study Start: 2017-08
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Primigravida patients undergoing transverse lower segment cesarean section

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Exclusion Criteria

• Previous laparotomies
• Postoperative fever
• Patients with preterm pregnancies or in labor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barbed suture ( STRATAFIX™ )	Barbed suture ( STRATAFIX™ )	Cesarean section incision is closed using barbed sutures
Conventional suture (VICRYL™)	Conventional suture (VICRYL™)	Cesarean section incision is closed using conventional sutures

Primary Outcome Measures

Name	Time	Method
Adhesions formation rate	Through study completion, an average of 3 year	Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Trial Locations

Locations (1)

Faculty of medicine, Cairo university; 🇪🇬 Cairo, Egypt