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Cesarean Wound Closure in Women With BMI 40 or Greater

Sponsor
Mednax Center for Research, Education, Quality and Safety (Other)
Overall Status
Completed
CT.gov ID
NCT02549131
Collaborator
Banner Health (Other)
420
Enrollment
2
Locations
2
Arms
64
Actual Duration (Months)
210
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Randomizing to Suture or Staple closure of Cesarean section
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Cesarean Wound Closure in Women With BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of wound complication, comparing the outcomes from the two arms [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.

    Secondary Outcome Measures

    1. Frequency of and risk factors for wound complication after cesarean delivery in the obese gravida. [2 years]

      wound complication frequency

    2. Type and location of cesarean incisions in the obese gravida. [2 years]

      type and location of incisions

    3. Effect of medical comorbidities on wound disruption. [2 years]

      medical comorbidities on wound disruption

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University Medical Center - Phoenix Phoenix Arizona United States 85006
    2 University of Colorado Denver Aurora Colorado United States 80045

    Sponsors and Collaborators

    • Mednax Center for Research, Education, Quality and Safety
    • Banner Health

    Investigators

    • Principal Investigator: Jordan Perlow, MD, Mednax Center for Research, Education, Quality and Safety

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mednax Center for Research, Education, Quality and Safety
    ClinicalTrials.gov Identifier:
    NCT02549131
    Other Study ID Numbers:
    • Cesarean Closure
    First Posted:
    Sep 15, 2015
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jan 12, 2021