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Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

NCT ID: NCT01713751

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-09-30

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.

Conditions

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Surgical Site Infection

Keywords

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Surgical site infection Cesarean section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Interrupted suturing Group

Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene \[Prolene®\]

Group Type ACTIVE_COMPARATOR

Interrupted suturing

Intervention Type OTHER

Skin is closed with interrupted mattress stitches using non-absorbable polypropylene \[Prolene®\]

Subcuticular suturing Group

Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene \[Prolene®\].

Group Type ACTIVE_COMPARATOR

Subcuticular suturing

Intervention Type OTHER

Skin is closed with subcuticular stitches using non-absorbable polypropylene \[Prolene®\]

Interventions

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Interrupted suturing

Skin is closed with interrupted mattress stitches using non-absorbable polypropylene \[Prolene®\]

Intervention Type OTHER

Subcuticular suturing

Skin is closed with subcuticular stitches using non-absorbable polypropylene \[Prolene®\]

Intervention Type OTHER

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ellaithy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moustafa I. Ibrahim, MD

Role: STUDY_DIRECTOR

Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University

References

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Ibrahim MI, Moustafa GF, Al-Hamid AS, Hussein MR. Superficial incisional surgical site infection rate after cesarean section in obese women: a randomized controlled trial of subcuticular versus interrupted skin suturing. Arch Gynecol Obstet. 2014 May;289(5):981-6. doi: 10.1007/s00404-013-3098-z. Epub 2013 Nov 24.

Reference Type DERIVED
PMID: 24272023 (View on PubMed)

Other Identifiers

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ASUOGRCT03-2012

Identifier Type: -

Identifier Source: org_study_id