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

Phase 3CompletedNCT02962011

Ziv Hospital102 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

102

Conditions

Cesarean Section

Interventions

Knotless barbed sutureDEVICE

uterine incision closure

polyglactin 910DEVICE

uterine incision closure

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Ziv Medical Center

Safed, Israel

Outcomes

Primary Outcomes

Uterine incision closure time

uterine incision closure time

Time frame: 5 months

Secondary Outcomes

uterine incision blood loss

Time frame: 5 months

hemostatic suture use

Time frame: 5 months

Data from ClinicalTrials.gov

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