Cesarean Skin Incision Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Wound Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pfannenstiel incision

Group Type OTHER

Pfannenstiel incision

Intervention Type PROCEDURE

Pfannenstiel incision at time of cesarean section

vertical skin incision

Group Type OTHER

vertical skin incision

Intervention Type PROCEDURE

vertical skin incision at time of cesarean section

Interventions

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Pfannenstiel incision

Pfannenstiel incision at time of cesarean section

Intervention Type PROCEDURE

vertical skin incision

vertical skin incision at time of cesarean section

Intervention Type PROCEDURE

Eligibility Criteria

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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