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

Primary Purpose

Cesarean Section

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Barbed suture ( STRATAFIX™ )

Conventional suture (VICRYL™)

About this trial

This is an interventional diagnostic trial for Cesarean Section focused on measuring Barbed sutures,Cesarean Section, adhesions

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Faculty of medicine, Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Barbed suture ( STRATAFIX™ )

Conventional suture (VICRYL™)

Arm Description

Cesarean section incision is closed using barbed sutures

Cesarean section incision is closed using conventional sutures

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03183362

First Posted

June 7, 2017

Last Updated

June 12, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03183362

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2017 (Anticipated)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cesarean Section

Keywords

Barbed sutures,Cesarean Section, adhesions

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Barbed suture ( STRATAFIX™ )

Arm Type

Experimental

Arm Description

Cesarean section incision is closed using barbed sutures

Arm Title

Conventional suture (VICRYL™)

Arm Type

Active Comparator

Arm Description

Cesarean section incision is closed using conventional sutures

Intervention Type

Device

Intervention Name(s)

Barbed suture ( STRATAFIX™ )

Intervention Description

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

Intervention Name(s)

Conventional suture (VICRYL™)

Intervention Description

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 .

Primary Outcome Measure Information:

Title

Adhesions formation rate

Description

Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Time Frame

Through study completion, an average of 3 year

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primigravida patients undergoing transverse lower segment cesarean section Exclusion Criteria: Previous laparotomies Postoperative fever Patients with preterm pregnancies or in labor

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Usama Fouda, Prof.

Phone

01095401375

umfrfouda@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Usama M. Fouda, Prof.

Organizational Affiliation

Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohamed Zayed, Prof.

Organizational Affiliation

Cairo University

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of medicine, Cairo university

City

Cairo

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Usama M Fouda, Prof.

umfrfouda@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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