Cesarean Skin Incision Trial

Wound Complication Clinical Trial

— C-SIT  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897376
• Other study ID #: C-SIT
• Status: Completed
• Phase: N/A
• First received: July 8, 2013
• Last updated: June 28, 2017
• Start date: July 2013
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 ,

Related Conditions & MeSH terms

• Wound Complication

Intervention

Procedure:
• Pfannenstiel incision
Pfannenstiel incision at time of cesarean section
• vertical skin incision
vertical skin incision at time of cesarean section

Locations

Country	Name	City	State
United States	UTMB	Galveston	Texas
United States	Memorial Hermann Hospital Texas Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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