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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Knotless barbed suture vs conventional suture of uterine incision

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

unblinded

Study Groups

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Knotless barbed suture

Group Type EXPERIMENTAL

Knotless barbed suture

Intervention Type DEVICE

uterine incision closure

polyglactin 910

Vicryl

Group Type ACTIVE_COMPARATOR

polyglactin 910

Intervention Type DEVICE

uterine incision closure

Interventions

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Knotless barbed suture

uterine incision closure

Intervention Type DEVICE

polyglactin 910

uterine incision closure

Intervention Type DEVICE

Other Intervention Names

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Stratafix Vicryl

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No