Cesarean Skin Incision Trial
Completed · Not applicable
Conditions studied: Wound Complication
In brief
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.
Key facts
- Study ID
- NCT01897376
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 228
- Starts
- 2013-07-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
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 ,
Where it is running
- UTMB — Galveston, Texas, United States
- Memorial Hermann Hospital Texas Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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