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NCT Number: NCT01897376

Cesarean Skin Incision Trial

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UTMB, Galveston, Texas, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Pfannenstiel incision

Procedure

Pfannenstiel incision at time of cesarean section

vertical skin incision

Procedure

vertical skin incision at time of cesarean section

Primary outcomes

  1. composite wound complication

    Time frame: 6 weeks post-op

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • The University of Texas Medical Branch, Galveston

Registry information

Official study title

The Comparative Effectiveness of Pfannenstiel Versus Vertical Skin Incision in Preventing Wound Complications After Cesarean Delivery in Morbidly Obese Women: a Randomized Clinical Trial.

Acronym: C-SIT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2013
Registry last updated
Jul 2, 2017

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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