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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01317095
The ClinicalTrials.gov registry entry for NCT01317095 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (74% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Related
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