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Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01713751
Enrollment
500
Registered
2012-10-25
Start date
2012-03-31
Completion date
2012-09-30
Last updated
2012-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

Surgical site infection, Cesarean section

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.

Interventions

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

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Surgical site infection30 days after the operative procedureWe used the definition devised and adopted by the Center for Disease Control and Prevention.

Secondary

MeasureTime frameDescription
Skin closure time15 minutes
Postoperative pain48 hoursMeasured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain
Short-term cosmetic wound outcome30 daysWe used Stony Brook Scar Evaluation Scale
Overall women satisfaction30 daysA questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026