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| Name | Class |
|---|---|
| Banner Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture | Active Comparator | Randomizing to Suture closure of Cesarean Section wound. In woman meeting inclusion criteria and not meeting exclusion criteria. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of and risk factors for wound complication after cesarean delivery in the obese gravida. | wound complication frequency | 2 years |
| Type and location of cesarean incisions in the obese gravida. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Perlow, MD | Pediatrix | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center - Phoenix | Phoenix | Arizona | 85006 | United States | ||
| University of Colorado Denver |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23467047 | Background | 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. | |
| 19461456 | Background | 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. |
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no individual patient data will be shared
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
type and location of incisions
| 2 years |
| Effect of medical comorbidities on wound disruption. | medical comorbidities on wound disruption | 2 years |
| Aurora |
| Colorado |
| 80045 |
| United States |
| 12423861 | Background | 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. |
| 20678746 | Background | 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. |
| 23765707 | Background | 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. |
| 23211124 | Background | 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. |
| 12603990 | Background | 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. |
| 21422859 | Background | 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. |
| 22105439 | Background | 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. |
| 22233403 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |