Cesarean Skin Incision Trial (C-SIT)
Primary Purpose
Wound Complication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pfannenstiel incision
vertical skin incision
Sponsored by
About this trial
This is an interventional prevention trial for Wound Complication focused on measuring wound, infection, cesarean delivery, obesity
Eligibility Criteria
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 ,
Sites / Locations
- UTMB
- Memorial Hermann Hospital Texas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pfannenstiel incision
vertical skin incision
Arm Description
Outcomes
Primary Outcome Measures
composite wound complication
includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations
Secondary Outcome Measures
Full Information
NCT ID
NCT01897376
First Posted
July 8, 2013
Last Updated
June 28, 2017
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT01897376
Brief Title
Cesarean Skin Incision Trial
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
The University of Texas Medical Branch, Galveston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Complication
Keywords
wound, infection, cesarean delivery, obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pfannenstiel incision
Arm Type
Other
Arm Title
vertical skin incision
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Pfannenstiel incision
Intervention Description
Pfannenstiel incision at time of cesarean section
Intervention Type
Procedure
Intervention Name(s)
vertical skin incision
Intervention Description
vertical skin incision at time of cesarean section
Primary Outcome Measure Information:
Title
composite wound complication
Description
includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations
Time Frame
6 weeks post-op
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 ,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline C Marrs, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTMB
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Memorial Hermann Hospital Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30060292
Citation
Marrs C, Blackwell S, Hester A, Olson G, Saade GR, Faro J, Pedroza C, Sibai B. Pfannenstiel versus Vertical Skin Incision for Cesarean Delivery in Women with Class III Obesity: A Randomized Trial. Am J Perinatol. 2019 Jan;36(1):97-104. doi: 10.1055/s-0038-1667287. Epub 2018 Jul 30.
Results Reference
derived
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