Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
232 participants
INTERVENTIONAL
2015-09-30
2021-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Suture
Randomizing to Suture closure of Cesarean Section wound. In woman meeting inclusion criteria and not meeting exclusion criteria.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Banner Health
OTHER
Pediatrix
OTHER
Responsible Party
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Principal Investigators
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Jordan Perlow, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatrix
Locations
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Banner University Medical Center - Phoenix
Phoenix, Arizona, United States
University of Colorado Denver
Aurora, Colorado, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Cesarean Closure
Identifier Type: -
Identifier Source: org_study_id
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