Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

Study Overview
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Brief Summary
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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
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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: Interrupted sutures. Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.

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

Conditions
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Suture Line Infection

Intervention / Treatment
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* Procedure: Subcutaneous tissue closure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. |