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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03183362
Enrollment
110
Registered
2017-06-12
Start date
2017-08-31
Completion date
2020-08-31
Last updated
2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

Barbed sutures,Cesarean Section, adhesions

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.

Interventions

DEVICEBarbed 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.

DEVICEConventional 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 .

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Primigravida patients undergoing transverse lower segment cesarean section

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Adhesions formation rateThrough study completion, an average of 3 yearPatients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Countries

Egypt

Contacts

Primary ContactUsama Fouda, Prof.
umfrfouda@yahoo.com01095401375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026