Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Time needed to close the uterine incision
Study Overview
Brief Summary
Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.
Detailed Description
A Randomized prospective case control study to evaluate the surgical outcome of using the new barbed bidirectional tissue controlling device in reducing the time and blood loss at uterine closure during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure is used and the occurrence of any tearing of the uterine muscles at the time closure of the uterine incision will be also studied. These will be the primary outcome measure and the secondary outcome measure will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative fever, and the number of sutures required to close the uterine incision.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All pregnant patients with an indication for delivery by C section
Exclusion Criteria
- •Patient refusing to participate in the study
Arms & Interventions
Stratafix Tissue control device
Closure of Uterine incision at C section
Intervention: Closure of uterine incision at C section (Procedure)
Vicryl suture
Closure of uterine incision at C section
Intervention: Closure of uterine incision at C section (Procedure)
Outcomes
Primary Outcomes
Time needed to close the uterine incision
Time Frame: 6 minutes
A model is set to evaluate success and failure according the ime needed to close the uterine incision if more or less than 6 minutes
Secondary Outcomes
- blood loss during uterine closure(intraoperative during uterine closure)
Investigators
Mohamed Zayed
Professor of Obstetrics and Gynecology Cairo University
Cairo University