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

Ziv Hospital

Status and phase: Completed; Phase 3

Conditions: Cesarean Section

Treatments: Device: polyglactin 910; Device: Knotless barbed suture

Study type: Interventional

Funder types: Other

Identifiers

NCT02962011

ZIVH

Details and patient eligibility

About

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

Enrollment: 102 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Knotless barbed suture

Experimental group

Treatment:

Device: Knotless barbed suture

polyglactin 910

Active Comparator group

Description:

Vicryl

Treatment:

Device: polyglactin 910