Cesarean Skin Incision Trial (C-SIT)

June 28, 2017 updated by: Caroline Carter Marrs, MD, The University of Texas Health Science Center, Houston

The Comparative Effectiveness of Pfannenstiel Versus Vertical Skin Incision in Preventing Wound Complications After Cesarean Delivery in Morbidly Obese Women: a Randomized Clinical Trial.

The purpose of this study is to determine if there is a difference between Pfannenstiel and midline vertical skin incision at time of cesarean section in preventing wound complications in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon admission and randomize them to one of the above incision types in the operating room. The investigators will follow them for 6 weeks post-op to evaluate for wound complications. There is minimal risk to the participant as both incision types are acceptable in current obstetrical practice. There is no direct benefit to the patient.

Currently, there is no level I evidence to support either Pfannenstiel or midline vertical skin incision in the prevention of wound complications in the obese patient undergoing cesarean section. Therefore, current practice is for the surgeon to make the decision based on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean section is a very common procedure, with a national rate of 32% of all live births in 2007. Not only does obesity increase the expectant mother's risk of a cesarean section, it is also a well recognized risk factor for wound complication. The cesarean wound complication rate in the morbidly obese population at the University Of Texas at Houston - Memorial Hermann Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight population, 28% compared to 1.4%. Results from this study could be extrapolated in the future to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use, shorter hospital stay, and overall lower health care costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

228

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
    • Texas
      • Galveston, Texas, United States, 77555
        • UTMB
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital Texas Medical Center

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:

  1. Pregnant women undergoing cesarean delivery for any indication, regardless of number of prior cesarean deliveries
  2. Age 18-50 years
  3. BMI of 40 kg/m2 or more

Exclusion Criteria:

  1. Underlying infection such as chorioamnionitis
  2. Rupture of membranes over 18 hours prior to cesarean section ,

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pfannenstiel incision
Procedure: Pfannenstiel incision
Pfannenstiel incision at time of cesarean section
Other: vertical skin incision
Procedure: vertical skin incision
vertical skin incision at time of cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite wound complication
Time Frame: 6 weeks post-op
includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations
6 weeks post-op

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Caroline C Marrs, MD, The University of Texas Health Science Center, Houston

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

July 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-SIT

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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