Cesarean Skin Incision Trial

NCT01897376 | Completed DMC

• 1 other identifier: C-SIT
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if there is a difference between Pfannenstiel and midline vertical skin incision at time of cesarean section in preventing wound complications in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon admission and randomize them to one of the above incision types in the operating room. The investigators will follow them for 6 weeks post-op to evaluate for wound complications. There is minimal risk to the participant as both incision types are acceptable in current obstetrical practice. There is no direct benefit to the patient. Currently, there is no level I evidence to support either Pfannenstiel or midline vertical skin incision in the prevention of wound complications in the obese patient undergoing cesarean section. Therefore, current practice is for the surgeon to make the decision based on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean section is a very common procedure, with a national rate of 32% of all live births in 2007. Not only does obesity increase the expectant mother's risk of a cesarean section, it is also a well recognized risk factor for wound complication. The cesarean wound complication rate in the morbidly obese population at the University Of Texas at Houston - Memorial Hermann Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight population, 28% compared to 1.4%. Results from this study could be extrapolated in the future to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use, shorter hospital stay, and overall lower health care costs.

Conditions

Wound Complication

Keywords

wound; infection; cesarean delivery; obesity

Outcome Measures

Primary Outcomes (1)

• composite wound complication

  includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations

  6 weeks post-op

Study Arms (2)

Pfannenstiel incision

OTHER

Procedure: Pfannenstiel incision

vertical skin incision

OTHER

Procedure: vertical skin incision

Interventions

Pfannenstiel incision PROCEDURE

Pfannenstiel incision at time of cesarean section

Pfannenstiel incision

vertical skin incision PROCEDURE

vertical skin incision at time of cesarean section

vertical skin incision

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women undergoing cesarean delivery for any indication, regardless of number of prior cesarean deliveries
• Age 18-50 years
• BMI of 40 kg/m2 or more

You may not qualify if:

• Underlying infection such as chorioamnionitis
• Rupture of membranes over 18 hours prior to cesarean section ,

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• The University of Texas Medical Branch, Galveston: collaborator

Study Sites (2)

UTMB

Galveston, Texas, 77555, United States

Location

Memorial Hermann Hospital Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Marrs C, Blackwell S, Hester A, Olson G, Saade GR, Faro J, Pedroza C, Sibai B. Pfannenstiel versus Vertical Skin Incision for Cesarean Delivery in Women with Class III Obesity: A Randomized Trial. Am J Perinatol. 2019 Jan;36(1):97-104. doi: 10.1055/s-0038-1667287. Epub 2018 Jul 30.

  PMID: 30060292 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Infections; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caroline C Marrs, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 12, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (2)