NCT02549131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

4.5 years

First QC Date

August 28, 2015

Last Update Submit

August 24, 2022

Conditions

C.Delivery; Penetration, Pregnant Uterus, by InstrumentObesity

Outcome Measures

Primary Outcomes (1)

  • Rate of wound complication, comparing the outcomes from the two arms

    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 Outcomes (3)

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

    2 years

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

    2 years

  • Effect of medical comorbidities on wound disruption.

    2 years

Study Arms (2)

Suture

ACTIVE COMPARATOR

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

Staples

ACTIVE COMPARATOR

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

Interventions

Randomizing to Suture or Staple closure of Cesarean sectionPROCEDURE

Randomizing to either surgical subcuticular suture or surgical staples in women of BMI greater than 40 undergoing Cesarean section delivery.

Also known as: suture or staples for skin closure
StaplesSuture

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banner University Medical Center - Phoenix

Phoenix, Arizona, 85006, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (10)

  • Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.

    PMID: 23467047BACKGROUND

  • ACOG practice bulletin no. 105: bariatric surgery and pregnancy. Obstet Gynecol. 2009 Jun;113(6):1405-1413. doi: 10.1097/AOG.0b013e3181ac0544. No abstract available.

    PMID: 19461456BACKGROUND

  • Myles TD, Gooch J, Santolaya J. Obesity as an independent risk factor for infectious morbidity in patients who undergo cesarean delivery. Obstet Gynecol. 2002 Nov;100(5 Pt 1):959-64. doi: 10.1016/s0029-7844(02)02323-2.

    PMID: 12423861BACKGROUND

  • Alanis MC, Villers MS, Law TL, Steadman EM, Robinson CJ. Complications of cesarean delivery in the massively obese parturient. Am J Obstet Gynecol. 2010 Sep;203(3):271.e1-7. doi: 10.1016/j.ajog.2010.06.049. Epub 2010 Aug 3.

    PMID: 20678746BACKGROUND

  • Conner SN, Verticchio JC, Tuuli MG, Odibo AO, Macones GA, Cahill AG. Maternal obesity and risk of postcesarean wound complications. Am J Perinatol. 2014 Apr;31(4):299-304. doi: 10.1055/s-0033-1348402. Epub 2013 Jun 13.

    PMID: 23765707BACKGROUND

  • Mackeen AD, Devaraj T, Baxter JK. Cesarean skin closure preferences: a survey of obstetricians. J Matern Fetal Neonatal Med. 2013 May;26(8):753-6. doi: 10.3109/14767058.2012.755509. Epub 2013 Jan 11.

    PMID: 23211124BACKGROUND

  • Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.

    PMID: 12603990BACKGROUND

  • Pevzner L, Swank M, Krepel C, Wing DA, Chan K, Edmiston CE Jr. Effects of maternal obesity on tissue concentrations of prophylactic cefazolin during cesarean delivery. Obstet Gynecol. 2011 Apr;117(4):877-882. doi: 10.1097/AOG.0b013e31820b95e4.

    PMID: 21422859BACKGROUND

  • McLean M, Hines R, Polinkovsky M, Stuebe A, Thorp J, Strauss R. Type of skin incision and wound complications in the obese parturient. Am J Perinatol. 2012 Apr;29(4):301-6. doi: 10.1055/s-0031-1295637. Epub 2011 Nov 21.

    PMID: 22105439BACKGROUND

  • Thornburg LL, Linder MA, Durie DE, Walker B, Pressman EK, Glantz JC. Risk factors for wound complications in morbidly obese women undergoing primary cesarean delivery. J Matern Fetal Neonatal Med. 2012 Sep;25(9):1544-8. doi: 10.3109/14767058.2011.653422. Epub 2012 Feb 13.

    PMID: 22233403BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Sutures

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Jordan Perlow, MD

    Pediatrix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2020

Study Completion

January 1, 2021

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

no individual patient data will be shared

Locations

US(2)