Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean Section
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJune 14, 2017
June 1, 2017
3 years
June 7, 2017
June 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Barbed suture ( STRATAFIX™ )
EXPERIMENTALCesarean section incision is closed using barbed sutures
Conventional suture (VICRYL™)
ACTIVE COMPARATORCesarean section incision is closed using conventional sutures
Interventions
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.
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 .
Eligibility Criteria
You may qualify if:
- Primigravida patients undergoing transverse lower segment cesarean section
You may not qualify if:
- Previous laparotomies
- Postoperative fever
- Patients with preterm pregnancies or in labor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of medicine, Cairo university
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Usama M. Fouda, Prof.
Cairo University
- STUDY CHAIR
Mohamed Zayed, Prof.
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
June 7, 2017
First Posted
June 12, 2017
Study Start
August 1, 2017
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
June 14, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share