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NCT01897376 · ClinicalTrials.gov registry record · NA
Cesarean Skin Incision Trial
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- NA
- Development phase
- 228
- Enrollment target
NCT01897376 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 228 participants.
The verdict
NCT01897376, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 228 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Pfannenstiel incision
- PROCEDURE vertical skin incision
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01897376
The ClinicalTrials.gov registry entry for NCT01897376 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pfannenstiel incision is the first listed.
NCT01897376 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01897376 about?
NCT01897376 is a clinical study titled "Cesarean Skin Incision Trial". 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 i...
What is the current status of trial NCT01897376?
This trial is currently completed. It is a NA study. The enrollment target is 228 participants. The study started on 2013-07. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01897376?
The interventions under investigation include: Pfannenstiel incision (PROCEDURE), vertical skin incision (PROCEDURE).
Who is sponsoring clinical trial NCT01897376?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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