NCT03183362

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

Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean Section; a Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DEVICE	Barbed suture ( STRATAFIX™ )	Cesarean section incision will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.
DEVICE	Conventional suture (VICRYL™)	Cesarean section incision will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures .

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2017-06-12
• Last updated: 2017-06-14

Locations

1 site across 1 country: Egypt