Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 500
- Primary Endpoint
- Surgical site infection
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Interrupted suturing Group
Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
Intervention: Interrupted suturing (Other)
Subcuticular suturing Group
Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene [Prolene®].
Intervention: Subcuticular suturing (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Skin closure time(15 minutes)
- Postoperative pain(48 hours)
- Short-term cosmetic wound outcome(30 days)
- Overall women satisfaction(30 days)
Investigators
Mohamed Ellaithy
Principal Investigator
Ain Shams University