Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

Ain Shams University

Status: Completed

Conditions: Surgical Site Infection

Treatments: Other: Interrupted suturing; Other: Subcuticular suturing

Study type: Interventional

Funder types: Other

Identifiers

NCT01713751

ASUOGRCT03-2012

Details and patient eligibility

About

The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.

Full description

This is a randomized controlled trial conducted in Ain-Shams University Maternity Hospital on the period from March 2012 till August 2012. It included 130 pregnant women who underwent elective Cesarean section.

The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.

Enrollment: 500 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: any female in childbearing period.
• Women planned for elective Cesarean section.
• Obese women (BMI ≥ 30 Kg/m2). Our study calculated the BMI of patients from their weight and height at admission, because the pre-pregnancy BMI was not available for all patients, and we hypothesized that the BMI at admission was a better indicator of body mass during the at-risk time for development of SSI than was the pre-pregnancy BMI.

Exclusion criteria

• Women who had concurrent overt infection (e.g.chorioamnionitis, pyelonephritis or chest infection).
• Women who had intraoperative events that may themselves predispose to perioperative infection (e.g. bowel injury, operative time more than 90 minutes, major blood loss).
• Women who had hemoglobin less than 10g/dl, preeclampsia, diabetes, rupture of membranes more than 12 hours, corticosteroid therapy.
• Patients who had non Pfannenstiel incision.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Interrupted suturing Group

Active Comparator group

Description:

Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene \[Prolene®\]

Treatment:

Other: Interrupted suturing

Subcuticular suturing Group

Active Comparator group

Description:

Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene \[Prolene®\].

Treatment:

Other: Subcuticular suturing