Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Other: Interrupted suturing
* Other: Subcuticular suturing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 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 suturing Group<br>Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®] | Other: Interrupted suturing<br>* Skin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]<br>|
| Active Comparator: Subcuticular suturing Group<br>Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]. | Other: Subcuticular suturing<br>* Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | We used the definition devised and adopted by the Center for Disease Control and Prevention. | 30 days after the operative procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical site infection, Cesarean section