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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: Completed NA study, sponsored by The University of Texas Health Science Center, Houston.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations
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 |
What the finished NCT01897376 record still lists
NCT01897376 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Pfannenstiel incision is the first listed.
NCT01897376 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01897376's enrollment target sits among peer trials
228 468th of 2000 higher than 1,530 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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