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Completed

NCT Number: NCT01713751

Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interrupted suturing

Other

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

Subcuticular suturing

Other

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

Primary outcomes

  1. 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

  1. Skin closure time

    Time frame: 15 minutes

  2. Postoperative pain

    Time frame: 48 hours

    Measured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain

  3. Short-term cosmetic wound outcome

    Time frame: 30 days

    We used Stony Brook Scar Evaluation Scale

  4. Overall women satisfaction

    Time frame: 30 days

    A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2012
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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