Clinical trial NCT04220294: Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
Official title: Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture Line Infection
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 1238
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical site infection rate.
timeFrame: From admission up to 6 weeks postpartum.
Secondary outcomes:
measure: Rate of re-admission due to surgical site infection.
timeFrame: From admission up to 6 weeks postpartum.
measure: Rate of postoperative febrile morbidity.
timeFrame: From admission up to 6 weeks postpartum.
measure: Rate of maternal fever.
timeFrame: From admission up to 6 weeks postpartum.
measure: Duration of maternal fever.
timeFrame: From admission up to 6 weeks postpartum.
measure: Rate of antibiotic use for the treatment of surgical site infection.
timeFrame: From admission up to 6 weeks postpartum.
measure: Cesraean section-to-surgical site infection time interval.
timeFrame: From admission up to 6 weeks postpartum.
measure: Rate of bacteremia.
timeFrame: From admission up to 6 weeks postpartum.
measure: Rate of sepsis.
timeFrame: From admission up to 6 weeks postpartum.
measure: Post-operative duration of hospitalization.
timeFrame: From admission up to 6 weeks postpartum.
measure: Postoperative pain.
timeFrame: From admission up to 6 weeks postpartum.
measure: Rate of postoperative anemia.
timeFrame: From admission up to 6 weeks postpartum.
measure: Blood transfusion rates.
timeFrame: From admission up to 6 weeks postpartum.
measure: Breastfeeding rates.
timeFrame: From admission up to 6 weeks postpartum.
measure: rate of voiding problems.
timeFrame: From admission up to 6 weeks postpartum.
measure: Venous thromboembolism rates.
timeFrame: From admission up to 6 weeks postpartum.
measure: Rate of admission to intensive care unit.
timeFrame: From admission up to 6 weeks postpartum.
measure: Maternal death rate
timeFrame: From admission up to 6 weeks postpartum.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam healthcare campus
Study officials:
affiliation: Rambam Healthcare Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References: