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NCT01114451 · ClinicalTrials.gov registry record · Phase 2
Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient
A Phase 2 study, sponsored by Prisma Health-Upstate.
- Terminated
- Registry status
- Phase 2
- Development phase
- 292
- Enrollment target
NCT01114451: Clinical Trial Phase 2 study, sponsored by Prisma Health-Upstate.
NCT01114451 is a Phase 2 study that was terminated before completion, run by Prisma Health-Upstate. The registered enrollment target is 292 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01114451, a Phase 2 study, was terminated before completion, sponsored by Prisma Health-Upstate.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 292 participants
- Enrollment target
Study Summary
Whenever a person has a cesarean section there is a risk that there will be a problem with healing of the wound. The most common type of wound healing problem is separation and opening of the skin and fatty tissue just beneath the skin. This type of wound healing problem happens more often when the patient has a high body weight. In most cases, metal staples are used to bring the skin together to close the wound. Usually, the staples are left in place for a longer time when the woman is heavy, in hopes of decreasing the chance of wound healing problems. But it is not known if leaving the staples in for a longer time is actually helpful. In some cases, leaving the staples in longer may cause more pain and will require you to see the doctor again to get the staples taken out. The purpose of this study is to see if there is any difference in how the wound heals in heavy women after cesarean section when the skin staples are removed after a short period of time versus a long period of time.
Primary Outcome
Any separation of the wound edge measuring greater than 1 cm that occurs from the time of staple placement to final wound assessment which occurs at 7-10 days after surgery.
Interventions
- PROCEDURE Removal of surgical skin staples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
Why NCT01114451 stopped before completion
NCT01114451 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 1 intervention - of which Removal of surgical skin staples is the first listed.
NCT01114451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01114451 about?
NCT01114451 is a clinical study titled "Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient". Whenever a person has a cesarean section there is a risk that there will be a problem with healing of the wound. The most common type of wound healing problem is separation and opening of the skin and fatty tissue just beneath the skin. This type of wound healing problem happens more often when the ...
What is the current status of trial NCT01114451?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 292 participants. The study started on 2009-10. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01114451?
The interventions under investigation include: Removal of surgical skin staples (PROCEDURE).
Who is sponsoring clinical trial NCT01114451?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01114451's enrollment target sits among peer trials
292 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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