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NCT03183362 Clinical Trial

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

Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03183362
Other study ID # Barbed sutures adhesions
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 7, 2017
Last updated June 12, 2017
Start date August 2017
Est. completion date August 2020

Study information
Verified date June 2017
Source Cairo University
Contact Usama Fouda, Prof.
Phone 01095401375
Email umfrfouda@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 110
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria:

- Previous laparotomies

- Postoperative fever

- Patients with preterm pregnancies or in labor

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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 .

Locations
Country Name City State
Egypt Faculty of medicine, Cairo university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adhesions formation rate Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures. Through study completion, an average of 3 year
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