Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713751
• Other study ID #: ASUOGRCT03-2012
• Status: Completed
• Phase: N/A
• First received: October 14, 2012
• Last updated: October 24, 2012
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	We used the definition devised and adopted by the Center for Disease Control and Prevention.	30 days after the operative procedure	Yes
Secondary	Skin closure time		15 minutes	Yes
Secondary	Postoperative pain	Measured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain	48 hours	No
Secondary	Short-term cosmetic wound outcome	We used Stony Brook Scar Evaluation Scale	30 days	No
Secondary	Overall women satisfaction	A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain	30 days	No