Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

Not Applicable

Completed

• Conditions: Surgical Site Infection
• Interventions: Other: Subcuticular suturing; Other: Interrupted suturing

• Registration Number: NCT01713751
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2012-10
• Study First Submitted: 2012-10-14
• Study First Submitted QC: 2012-10-24
• Last Update Submitted: 2012-10-24
• Study First Posted: 2012-10-25
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcuticular suturing Group	Subcuticular suturing	Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene \[Prolene®\].
Interrupted suturing Group	Interrupted suturing	Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene \[Prolene®\]

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days after the operative procedure	We used the definition devised and adopted by the Center for Disease Control and Prevention.

Secondary Outcome Measures

Name	Time	Method
Skin closure time	15 minutes
Postoperative pain	48 hours	Measured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain
Short-term cosmetic wound outcome	30 days	We used Stony Brook Scar Evaluation Scale
Overall women satisfaction	30 days	A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain