Cesarean Skin Incision Trial | NCT01897376

Studies
Cesarean Skin Incision Trial

NCT01897376

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Jul 2, 2017Actual

Enrollment

228Actual

Phase

Not Applicable

Conditions

Wound Complication

Interventions

Pfannenstiel incision
vertical skin incision

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Jul 8, 2013

First Submission Date that Met QC Criteria

Jul 11, 2013

First Posted Date

Jul 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2017

Last Update Posted Date

Jul 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Caroline Carter Marrs, MD, M.D., The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Name	Class
The University of Texas Medical Branch, Galveston	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

228Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pfannenstiel incision	Other		Procedure: Pfannenstiel incision
vertical skin incision	Other		Procedure: vertical skin incision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pfannenstiel incision	Procedure	Pfannenstiel incision at time of cesarean section	Pfannenstiel incision

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 ,

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline C Marrs, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UTMB		Galveston	Texas	77555	United States
Memorial Hermann Hospital Texas Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30060292	Derived	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.

ID	Term
D014947	Wounds and Injuries
D007239	Infections
D009765	Obesity

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases