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NCT01317095 · ClinicalTrials.gov registry record · NA
A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
A NA study of Pain, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT01317095: Completed NA study of Pain, sponsored by Thomas Jefferson University.
NCT01317095 is a NA study of Pain that has completed, run by Thomas Jefferson University. The registered enrollment target is 80 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01317095, a NA study of Pain, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method is better than the other. Open heart surgery always requires a sternotomy, and at the end of surgery the sternum needs to be closed. The sternum can be closed with Stainless Steel Wires or Sternalock rigid sternal closure system with equivocal results; however, the outcomes of these two methods have never been investigated in a randomized study. Thus, the investigators are conducting this study to compare two different methods of closure if one method demonstrates any recovery benefit over the other, using randomizing the subjects 1:1 to either rigid fixation with Sternalock or stainless steel wire closure. Recover benefit will be measured by postoperative intubation time, length of intensive care unit stay, and overall postoperative length of stay
Primary Outcome
The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure
Conditions Studied
Interventions
- DEVICE Sternalock Rigid Fixation
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-09 |
| Phase | NA |
What the finished NCT01317095 record still lists
NCT01317095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Sternalock Rigid Fixation is the first listed.
NCT01317095 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01317095 about?
NCT01317095 is a clinical study titled "A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure". The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method is better than the other. Open heart surgery always requires a sternotomy, and at the end of surgery the sternum needs to be closed. The sternum ...
What is the current status of trial NCT01317095?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2011-03. Estimated completion is 2016-09.
What conditions does trial NCT01317095 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT01317095?
The interventions under investigation include: Sternalock Rigid Fixation (DEVICE).
Who is sponsoring clinical trial NCT01317095?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01317095 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01317095's enrollment target sits among peer trials
80 193rd of 374 higher than 171 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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.
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