Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.

Barzilai Medical Center

Status: Completed

Conditions: Cesarean Section

Treatments: Device: Vicryl suture; Device: Stratafix suture

Study type: Interventional

Funder types: Other

Identifiers

NCT03159871

BRZ 0018-16 CTIL

Details and patient eligibility

About

A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section.

Full description

A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.These will be the primary outcome measures. The secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..

Enrollment: 73 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant patients with an obstetrical indication for delivery by Cesarean section

Exclusion criteria

• Patients with blood clotting disorders.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups

Stratafix suture

Experimental group

Treatment:

Device: Stratafix suture

Vicryl suture

Active Comparator group

Treatment:

Device: Vicryl suture