Uterine Closure at C-section by Stratafix Tissue Control... | NCT02288013

Studies
Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study

NCT02288013

Sponsor

Mohamed Zayed

Status

Completed

Last Update Posted

Jan 27, 2016Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Cesarean Section

Interventions

Closure of uterine incision at C section

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 5, 2014

First Submission Date that Met QC Criteria

Nov 10, 2014

First Posted Date

Nov 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2016

Last Update Posted Date

Jan 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Zayed, Professor of Obstetrics and Gynecology Cairo University, Cairo UniversitySponsor-Investigator

Lead Sponsor

Mohamed ZayedOTHER

Collaborators

Name	Class
Cairo University	OTHER
Johnson & Johnson Medical Companies	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stratafix Tissue control device	Other	Closure of Uterine incision at C section	Procedure: Closure of uterine incision at C section
Vicryl suture	Other	Closure of uterine incision at C section	Procedure: Closure of uterine incision at C section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closure of uterine incision at C section	Procedure	Closure of uterine incision at Cesarean section	Stratafix Tissue control device Vicryl suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time needed to close the uterine incision	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	6 minutes

Secondary Outcomes

Measure	Description	Time Frame
blood loss during uterine closure		intraoperative during uterine closure

Other Outcomes

Measure	Description	Time Frame
Duration of hospital stay		Six weeks following the cesarean delivery (completion of the postpartum period)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pregnant patients with an indication for delivery by C section

Exclusion Criteria:

Patient refusing to participate in the study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed Z Ahmed, MD PhD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Cairo University		Cairo	Cairo Governorate	11559	Egypt