Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

October 24, 2012 updated by: Mohamed Ellaithy, Ain Shams University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interrupted suturing Group
Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
Other: Interrupted suturing
Skin is 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®].
Other: Subcuticular suturing
Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after the operative procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin closure time
Time Frame: 15 minutes
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
48 hours
Short-term cosmetic wound outcome
Time Frame: 30 days
We used Stony Brook Scar Evaluation Scale
30 days
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Moustafa I. Ibrahim, MD, Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 14, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASUOGRCT03-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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