Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

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.

Study Overview

• Status: Completed
• Conditions: Suture Line Infection
• Intervention / Treatment: Procedure: Subcutaneous tissue closure

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 Type: Interventional
• Enrollment (Actual): 1238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Healthcare Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interrupted sutures; Subcutaneous tissue closure by interrupted sutures.	Procedure: Subcutaneous tissue closure; Subcutaneous tissue closure with 2-0 vicryl suture.
Active Comparator: Continuous sutures; Subcutaneous tissue closure by continuous sutures.	Procedure: Subcutaneous tissue closure; Subcutaneous tissue closure with 2-0 vicryl suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection rate.	Surgical site infection rate.	From admission up to 6 weeks postpartum.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 0621-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No