Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

NCT01713751 | Completed DMC

• 1 other identifier: ASUOGRCT03-2012
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Surgical Site Infection

Keywords

Surgical site infection; Cesarean section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Skin closure time

  15 minutes

• Postoperative pain

  48 hours

• Short-term cosmetic wound outcome

  30 days

• Overall women satisfaction

  30 days

Study Arms (2)

Interrupted suturing Group

ACTIVE COMPARATOR

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

Other: Interrupted suturing

Subcuticular suturing Group

ACTIVE COMPARATOR

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

Other: Subcuticular suturing

Interventions

Interrupted suturing OTHER

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

Interrupted suturing Group

Subcuticular suturing OTHER

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

Subcuticular suturing Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• 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.

  PMID: 24272023 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Moustafa I. Ibrahim, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2012
• First Posted: October 25, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 25, 2012

Record last verified: 2012-10