Cesarean Wound Closure in Women With BMI 40 or Greater

August 24, 2022 updated by: Pediatrix

Cesarean Wound Closure in Women With BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples

The purpose of this randomized controlled prospective trial is to guide physicians on the most effective evidenced based skin closure during a cesarean section for the obese gravida, defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular sutures and surgical staples.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will screen and attempt to enroll pregnant women admitted to labor and delivery who have a BMI of 40 or greater. The participants will be randomized to receiving skin closure with subcuticular sutures or surgical staples if they undergo cesarean section. Either technique is currently standard of care. Participants who end up undergoing cesarean section will be included in the final data analysis. The participants will be followed for wound complication in the first 6 weeks post operatively. Wound complication will be defined as wound disruption or infection within 6 weeks post operatively.

Design and Project Type This study is a randomized controlled trial. At the study facility, in 2012 and 2013, over 300 cesarean sections were performed each year in women with BMI of 40 or greater. Based on this, the investigators expect the duration of the study to be 2 years. Randomization and data collection will be completed on 420 women.

Description of Intervention Two interventions will be used in this project: subcuticular suture and surgical staples. The subcuticular suture will be the size and type of suture chosen by the surgeon at the time of cesarean. The surgical staples will be the standard staples used on the labor and delivery unit.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center - Phoenix
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant woman
  • Time to approach and consent the patient prior to undergoing cesarean delivery
  • Able to give informed consent, include age 18 or greater and ability to read and understand English
  • BMI of 40 or greater on most recent hospital documentation
  • Willingness to participate in the study and ability to read, understand and sign the informed consent document

Exclusion Criteria:

  • Inability to give informed consent, including inability to read and understand English and age under 18 years
  • Evidence of current skin infection or breakdown at or near the site of surgical incision
  • Any immune compromised status, including AIDS
  • Negative pressure wound therapy applied at time of surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Suture
Randomizing to Suture closure of Cesarean Section wound. In woman meeting inclusion criteria and not meeting exclusion criteria.
Procedure: Randomizing to Suture or Staple closure of Cesarean section
Randomizing to either surgical subcuticular suture or surgical staples in women of BMI greater than 40 undergoing Cesarean section delivery.
Other Names:
  • suture or staples for skin closure
ACTIVE_COMPARATOR: Staples

Women in this Arm will be assigned to Standard Surgical Staples closure of Cesarean section.

Women will have met inclusion criteria and not meet exclusion criteria and willing to consent to study. Intervention is the randomization to either Arm. Both are standard of care at this facility.
Procedure: Randomizing to Suture or Staple closure of Cesarean section
Randomizing to either surgical subcuticular suture or surgical staples in women of BMI greater than 40 undergoing Cesarean section delivery.
Other Names:
  • suture or staples for skin closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of wound complication, comparing the outcomes from the two arms
Time Frame: 2 years
Rate of wound complication comparing the outcomes of subcuticular sutures to surgical staples for cesarean wound closure in the obese gravida during the first 6 weeks postpartum.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of and risk factors for wound complication after cesarean delivery in the obese gravida.
Time Frame: 2 years
wound complication frequency
2 years
Type and location of cesarean incisions in the obese gravida.
Time Frame: 2 years
type and location of incisions
2 years
Effect of medical comorbidities on wound disruption.
Time Frame: 2 years
medical comorbidities on wound disruption
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Collaborators

Banner Health

Investigators

  • Principal Investigator: Jordan Perlow, MD, Pediatrix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (ESTIMATE)

September 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Cesarean Closure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no individual patient data will be shared

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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