A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
This study is currently recruiting participants.
Verified May 2013 by Thomas Jefferson University
Sponsor:
Thomas Jefferson University
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01317095
First received: March 10, 2011
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Pain |
Device: Sternalock Rigid Fixation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure |
Resource links provided by NLM:
Further study details as provided by Thomas Jefferson University:
Primary Outcome Measures:
- Intubation time [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Length of ICU stay, hospital stay and pain scores. [ Time Frame: 1 month after surgery ] [ Designated as safety issue: Yes ]The secondary objectives are to trend length of postoperative intensive care unit stay and postoperative length of hospital stay. We will also monitor the patient's pain scores and any incidences of sternal infection, sternal dehiscence, and pneumonia.
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Wire closure is the intervention
Patients will have their sternum closed using stainless steel wires.
|
Device: Sternalock Rigid Fixation
Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
|
Active Comparator: Rigid fixation
Patients will have their sternum closed by rigid fixation using Starnalock plates.
|
Device: Sternalock Rigid Fixation
Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.
- patient age ≥18 and <80 .
- patient undergoing elective surgery.
- patient undergoing urgent surgery (defined as surgery scheduled while the patient is in the hospital and performed during the same hospital admission with stable medical condition)
- patients who is willing to sign the informed consent to participate the study.
Exclusion Criteria:
Pre- operative exclusion criteria:
- patient undergoing redo-sternotomy.
- patient undergoing emergent surgery (defined as life-threating or unstable condition requiring surgery on the same day of the surgical consultation.)
- patients on dialysis
- patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.
- patients with body mass index ≥ 40.
- patients with active endocarditis.
- patients with known metal allergy.
- patient who refuses consent.
- patient who is unable to follow the postoperative instructions.
Intraoperative exclusion criteria:
- osteoporosis or poor quality of sternum.
- unstable sternal fracture.
- sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined by direct measurement.
- bilateral mammary artery harvest (causing poor blood supply to the sternum).
- patients in whom the chest needs to be left open due to medical reasons.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317095
Contacts
| Contact: Hitoshi Hirose, MD, PhD | 215-955-5654 | genex@nifty.com |
| Contact: James T Diehl, MD | 215-955-5654 | James.Diehl@jefferson.edu |
Locations
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | Recruiting |
| Phialdelphia, Pennsylvania, United States, 19107 | |
| Contact: Hitoshi Hirose, MD, PhD 215-955-5654 genex@nifty.com | |
| Contact: James T Diehl, MD 215-955-5654 James.Diehl@jefferson.edu | |
Sponsors and Collaborators
Thomas Jefferson University
Investigators
| Principal Investigator: | Hitoshi Hirose, MD, PhD | Thomas Jefferson University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT01317095 History of Changes |
| Other Study ID Numbers: | Sternal Closure |
| Study First Received: | March 10, 2011 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Thomas Jefferson University:
|
Rigid fixation Sternal closure Open heart surgery |
ClinicalTrials.gov processed this record on May 21, 2013