Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

Overview

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 Title of Study: “Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2012

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.

Interventions

  • Other: Interrupted suturing
    • Skin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
  • Other: Subcuticular suturing
    • Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]

Arms, Groups and Cohorts

  • Active Comparator: Interrupted suturing Group
    • Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
  • Active Comparator: Subcuticular suturing Group
    • Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene [Prolene®].

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed Ellaithy, Principal Investigator – Ain Shams University
  • Overall Official(s)
    • Moustafa I. Ibrahim, MD, Study Director, Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University

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