Trial Comparing Barbed and Non-barbed Suture for Uterine... | NCT02962011

Studies
Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section

NCT02962011

Sponsor

Ziv Hospital

Status

Completed

Last Update Posted

Jun 27, 2018Actual

Enrollment

102Actual

Phase

Phase 3

Conditions

Cesarean Section

Interventions

Knotless barbed suture
polyglactin 910

Countries

Israel

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

Jun 2018

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

Aug 1, 2016Actual

Primary Completion Date

Mar 31, 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Nov 9, 2016

First Submission Date that Met QC Criteria

Nov 10, 2016

First Posted Date

Nov 11, 2016Estimated

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

Jun 25, 2018

Last Update Posted Date

Jun 27, 2018Actual

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

This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained

Detailed Description

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Knotless barbed suture	Experimental		Device: Knotless barbed suture
polyglactin 910	Active Comparator	Vicryl	Device: polyglactin 910

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Knotless barbed suture	Device	uterine incision closure	Knotless barbed suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uterine incision closure time	uterine incision closure time	5 months

Secondary Outcomes

Measure	Description	Time Frame
uterine incision blood loss	uterine incision blood loss	5 months
hemostatic suture use	hemostatic suture use	5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective cesarean
elective repeat cesarean

Exclusion Criteria:

emergent or urgent cesarean
PROM
chorioamninitis
placental abruption
placenta previa or accreta
known uterine fibroids
women with known medical problems such as coagulopathy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Peleg	Ziv Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziv Medical Center		Safed		13100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29496259	Derived	Peleg D, Ahmad RS, Warsof SL, Marcus-Braun N, Sciaky-Tamir Y, Ben Shachar I. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at cesarean delivery. Am J Obstet Gynecol. 2018 Mar;218(3):343.e1-343.e7. doi: 10.1016/j.ajog.2018.01.043. Epub 2018 Feb 5.