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

NCT ID: NCT03183362

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2020-08-31

Brief Summary

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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

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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

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Barbed suture ( STRATAFIX™ )

Cesarean section incision is closed using barbed sutures

Group Type EXPERIMENTAL

Barbed suture ( STRATAFIX™ )

Intervention Type DEVICE

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 is closed using conventional sutures

Group Type ACTIVE_COMPARATOR

Conventional suture (VICRYL™)

Intervention Type DEVICE

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 .

Interventions

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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.

Intervention Type 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 .

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Usama M Fouda

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Usama M. Fouda, Prof.

Role: STUDY_CHAIR

Cairo University

Mohamed Zayed, Prof.

Role: STUDY_CHAIR

Cairo University

Locations

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Faculty of medicine, Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Usama Fouda, Prof.

Role: CONTACT

01095401375

Facility Contacts

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Usama M Fouda, Prof.

Role: primary

Other Identifiers

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Barbed sutures adhesions

Identifier Type: -

Identifier Source: org_study_id

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