ClinicalTrials.Veeva

Menu

Cesarean Skin Incision Trial (C-SIT)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Wound Complication

Treatments

Procedure: Pfannenstiel incision
Procedure: vertical skin incision

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

228 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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 ,

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

228 participants in 2 patient groups

Pfannenstiel incision
Other group
Treatment:
Procedure: Pfannenstiel incision
vertical skin incision
Other group
Treatment:
Procedure: vertical skin incision

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems