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Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

Primary Purpose

Surgical Site Infection

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Interrupted suturing

Subcuticular suturing

About this trial

This is an interventional treatment trial for Surgical Site Infection focused on measuring Surgical site infection, Cesarean section

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Interrupted suturing Group

Subcuticular suturing Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Surgical site infection

We used the definition devised and adopted by the Center for Disease Control and Prevention.

Secondary Outcome Measures

Skin closure time

Postoperative pain

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

Short-term cosmetic wound outcome

We used Stony Brook Scar Evaluation Scale

Overall women satisfaction

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

Full Information

NCT ID

NCT01713751

First Posted

October 14, 2012

Last Updated

October 24, 2012

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT01713751

Brief Title

Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infection

Keywords

Surgical site infection, Cesarean section

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interrupted suturing Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Subcuticular suturing Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Interrupted suturing

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Subcuticular suturing

Intervention Description

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

Primary Outcome Measure Information:

Title

Surgical site infection

Description

We used the definition devised and adopted by the Center for Disease Control and Prevention.

Time Frame

30 days after the operative procedure

Secondary Outcome Measure Information:

Title

Skin closure time

Time Frame

15 minutes

Title

Postoperative pain

Description

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

Time Frame

48 hours

Title

Short-term cosmetic wound outcome

Description

We used Stony Brook Scar Evaluation Scale

Time Frame

30 days

Title

Overall women satisfaction

Description

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

Time Frame

30 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moustafa I. Ibrahim, MD

Organizational Affiliation

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

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

24272023

Citation

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.

Results Reference

derived

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Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

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