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

Cairo University (CU)

Status: Unknown

Conditions: Cesarean Section

Treatments: Device: Conventional suture (VICRYL™); Device: Barbed suture ( STRATAFIX™ )

Study type: Interventional

Funder types: Other

Identifiers

NCT03183362

Barbed sutures adhesions

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primigravida patients undergoing transverse lower segment cesarean section

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Barbed suture ( STRATAFIX™ )

Experimental group

Description:

Cesarean section incision is closed using barbed sutures

Treatment:

Device: Barbed suture ( STRATAFIX™ )

Conventional suture (VICRYL™)

Active Comparator group

Description:

Cesarean section incision is closed using conventional sutures

Treatment:

Device: Conventional suture (VICRYL™)