Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

Suture Line Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220294
• Other study ID #: 0621-19-RMB
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: October 20, 2022

Study information

• Verified date: February 2023
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1238
• Est. completion date: October 20, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Suture Line Infection

Intervention

Procedure:
• Subcutaneous tissue closure
Subcutaneous tissue closure with 2-0 vicryl suture.

Locations

Country	Name	City	State
Israel	Rambam healthcare campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection rate.	Surgical site infection rate.	From admission up to 6 weeks postpartum.
Secondary	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.
Secondary	Rate of postoperative febrile morbidity.	Rate of maternal body temperature > 38°C.	From admission up to 6 weeks postpartum.
Secondary	Rate of maternal fever.	Rate of maternal fever in degrees celsius.	From admission up to 6 weeks postpartum.
Secondary	Duration of maternal fever.	Duration of maternal fever in days.	From admission up to 6 weeks postpartum.
Secondary	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.
Secondary	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.
Secondary	Rate of bacteremia.	Rate of bacteremia.	From admission up to 6 weeks postpartum.
Secondary	Rate of sepsis.	Rate of sepsis.	From admission up to 6 weeks postpartum.
Secondary	Post-operative duration of hospitalization.	Post-operative duration of hospitalization in days.	From admission up to 6 weeks postpartum.
Secondary	Postoperative pain.	Postoperative pain based on the visual analogue scale score ranging from 0-10.	From admission up to 6 weeks postpartum.
Secondary	Rate of postoperative anemia.	Rate of a hemoglobin level of under 10 gr/dL	From admission up to 6 weeks postpartum.
Secondary	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.
Secondary	Breastfeeding rates.	Breastfeeding rates.	From admission up to 6 weeks postpartum.
Secondary	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.
Secondary	Venous thromboembolism rates.	Venous thromboembolism rates.	From admission up to 6 weeks postpartum.
Secondary	Rate of admission to intensive care unit.	Rates of admission to intensive care unit	From admission up to 6 weeks postpartum.
Secondary	Maternal death rate	Maternal death rate.	From admission up to 6 weeks postpartum.