Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

Rambam Health Care Campus

Status: Completed

Conditions: Suture Line Infection

Treatments: Procedure: Subcutaneous tissue closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04220294

0621-19-RMB

Details and patient eligibility

About

A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.

Full description

Patients at term that are candidates for elective cesarean section will receive an explanation regarding the study and sign informed consent. Patients will then be divided randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:

1. Interrupted sutures.
2. Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.

Enrollment: 1,238 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women undergoing elective cesarean section.
• Subcutaneous tissue layer>2 centimeter according to ultrasound.

Exclusion criteria

• Non-elective CS.
• Fever during the 48 hours prior to surgery.
• Antibiotic treatment during the 48 hours prior to surgery.
• Inability to give informed consent.
• Preterm delivery (< 37 weeks' gestation).
• Fetal death.
• Known fetal anomalies or placental abnormalities.
• Immunosuppressive conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,238 participants in 2 patient groups

Interrupted sutures

Active Comparator group

Description:

Subcutaneous tissue closure by interrupted sutures.

Treatment:

Procedure: Subcutaneous tissue closure

Continuous sutures

Active Comparator group

Description:

Subcutaneous tissue closure by continuous sutures.

Treatment:

Procedure: Subcutaneous tissue closure