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Completed

NCT Number: NCT02549131

Cesarean Wound Closure in Women With BMI 40 or Greater

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Banner University Medical Center - Phoenix, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Randomizing to Suture or Staple closure of Cesarean section

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 2 years

    wound complication frequency

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

    Time frame: 2 years

    type and location of incisions

  3. Effect of medical comorbidities on wound disruption.

    Time frame: 2 years

    medical comorbidities on wound disruption

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Collaborators

  • Banner Health

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Sep 15, 2015
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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