Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamed Ellaithy, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01713751
First received: October 14, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Surgical Site Infection
Other: Interrupted suturing
Other: Subcuticular suturing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 30 days after the operative procedure ] [ Designated as safety issue: Yes ]
    We used the definition devised and adopted by the Center for Disease Control and Prevention.


Secondary Outcome Measures:
  • Skin closure time [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
  • Postoperative pain [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We used Stony Brook Scar Evaluation Scale

  • Overall women satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain


Enrollment: 500
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713751

Sponsors and Collaborators
Ain Shams University
Investigators
Study Director: Moustafa I. Ibrahim, MD Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
  More Information

No publications provided

Responsible Party: Mohamed Ellaithy, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT01713751     History of Changes
Other Study ID Numbers: ASUOGRCT03-2012
Study First Received: October 14, 2012
Last Updated: October 24, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams University:
Surgical site infection
Cesarean section

ClinicalTrials.gov processed this record on April 17, 2014