Skin Incisions and Wound Complication Rates for C-sections in Obese Women

Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery

It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.

Study Overview

• Status: Unknown
• Conditions: Obesity; Surgical Wound; Infection; Cesarean Section
• Intervention / Treatment: Procedure: Midline Vertical; Procedure: High Transverse

• Study Type: Interventional
• Enrollment (Anticipated): 309
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter R Cole, MD; Phone Number: 518-262-4942; Email: colep@mail.amc.edu
• Study Contact Backup: Name: Olga T Filippova, MD; Phone Number: 845-661-5716; Email: filippo@mail.amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Peter R Cole, MD; Phone Number: 518-262-4131; Email: colep@mail.amc.edu
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center Obstetrics and Gynecology
      • Contact: Peter R Cole, MD; Phone Number: 528-264-1800; Email: colep@mail.amc.edu
    • Ballston Spa, New York, United States, 12020
      • Recruiting
      • Albany Medical Center Obstetrics and Gynecology
      • Contact: Peter R Cole, MD; Phone Number: 518-262-1200; Email: colep@mail.amc.edu
    • Clifton Park, New York, United States, 12065
      • Recruiting
      • Albany Medical Center Obstetrics and Gynecology
      • Contact: Peter R Cole, MD; Phone Number: 518-264-1900; Email: colep@mail.amc.edu
    • Delmar, New York, United States, 12054
      • Recruiting
      • Albany Medical Center Obstetrics and Gynecology
      • Contact: Peter R Cole, MD; Phone Number: 518-264-0701; Email: colep@mail.amc.edu
    • Latham, New York, United States, 12110
      • Recruiting
      • Albany Medical Center Obstetrics and Gynecology
      • Contact: Peter R Cole, MD; Phone Number: 518-264-5053; Email: colep@mail.amc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pre-pregnancy BMI equal or greater than 40

Exclusion Criteria:

• prior cesarean section or laparotomy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Low Transverse; Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location
Experimental: Midline Vertical; Patients in this arm will undergo their cesarean section using a midline vertical skin incision	Procedure: Midline Vertical; Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis
Experimental: High Transverse; Patients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus	Procedure: High Transverse; Cesarean section performed using a transverse skin incision located above the pannus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wound Complications	6 months

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 4128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO