Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

Not Applicable

Completed

• Conditions: Suture Line Infection
• Interventions: Procedure: Subcutaneous tissue closure

• Registration Number: NCT04220294
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Study Start: 2020-01-10
• Primary Completion: 2022-04-30
• Study Completion: 2022-10-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1238

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interrupted sutures	Subcutaneous tissue closure	Subcutaneous tissue closure by interrupted sutures.
Continuous sutures	Subcutaneous tissue closure	Subcutaneous tissue closure by continuous sutures.

Primary Outcome Measures

Name	Time	Method
Surgical site infection rate.	From admission up to 6 weeks postpartum.	Surgical site infection rate.

Secondary Outcome Measures

Name	Time	Method
Rate of re-admission due to surgical site infection.	From admission up to 6 weeks postpartum.	rate of re-admission within 6 weeks postpartum due to surgical site infection.
Rate of postoperative febrile morbidity.	From admission up to 6 weeks postpartum.	Rate of maternal body temperature \> 38°C.
Rate of maternal fever.	From admission up to 6 weeks postpartum.	Rate of maternal fever in degrees celsius.
Duration of maternal fever.	From admission up to 6 weeks postpartum.	Duration of maternal fever in days.
Rate of antibiotic use for the treatment of surgical site infection.	From admission up to 6 weeks postpartum.	Rate of antibiotic use for the treatment of surgical site infection.
Cesraean section-to-surgical site infection time interval.	From admission up to 6 weeks postpartum.	Cesraean section-to-surgical site infection time interval in days.
Blood transfusion rates.	From admission up to 6 weeks postpartum.	Blood transfusion rates (recommended to patients with a postpartum hemoglobin level of under 7 gr/dL or between 7-8 gr/dL if anemia related symptoms are present)
Rate of bacteremia.	From admission up to 6 weeks postpartum.	Rate of bacteremia.
Rate of sepsis.	From admission up to 6 weeks postpartum.	Rate of sepsis.
Breastfeeding rates.	From admission up to 6 weeks postpartum.	Breastfeeding rates.
Post-operative duration of hospitalization.	From admission up to 6 weeks postpartum.	Post-operative duration of hospitalization in days.
Postoperative pain.	From admission up to 6 weeks postpartum.	Postoperative pain based on the visual analogue scale score ranging from 0-10.
Rate of postoperative anemia.	From admission up to 6 weeks postpartum.	Rate of a hemoglobin level of under 10 gr/dL
rate of voiding problems.	From admission up to 6 weeks postpartum.	Rate of need for either intermittent catheterization or 24-hour foley insertion to void
Venous thromboembolism rates.	From admission up to 6 weeks postpartum.	Venous thromboembolism rates.
Rate of admission to intensive care unit.	From admission up to 6 weeks postpartum.	Rates of admission to intensive care unit
Maternal death rate	From admission up to 6 weeks postpartum.	Maternal death rate.

Trial Locations

Locations (1)

Rambam healthcare campus; 🇮🇱 Haifa, Israel