Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section (Stratafix)

Evangelical Community Hospital, Lewisburg, PA

Status: Completed

Conditions: Hysterotomy Closure

Treatments: Procedure: Stratafix synthetic barbed suture

Study type: Interventional

Funder types: Other

Identifiers

NCT02517710

ECH/TCMC101

Details and patient eligibility

About

Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.

Full description

Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.

Enrollment: 100 patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.

Exclusion criteria

• General Anesthesia
• Non-consent to participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Group of patients receiving standard hysterotomy closure with synthetic braided suture

Treatment:

Procedure: Stratafix synthetic barbed suture

Stratfix

Experimental group

Description:

group of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain

Treatment:

Procedure: Stratafix synthetic barbed suture