Cesarean Skin Incision Trial



Status:Recruiting
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:July 2013
End Date:December 2016
Contact:Caroline C Marrs, MD
Email:carolinemarrs@gmail.com
Phone:214 9528484

Use our guide to learn which trials are right for you!

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


Inclusion Criteria:

1. Pregnant women undergoing cesarean delivery for any indication, regardless of number
of prior cesarean deliveries

2. Age 18-50 years

3. BMI of 40 kg/m2 or more

Exclusion Criteria:

1. Underlying infection such as chorioamnionitis

2. Rupture of membranes over 18 hours prior to cesarean section ,
We found this trial at
1
site
Houston, Texas 77030
Phone: 214-952-8484
?
mi
from
Houston, TX
Click here to add this to my saved trials