A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure

Completed · Not applicable

Conditions studied: Pain

In brief

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

Key facts

Study ID

NCT01317095

Run by

Thomas Jefferson University

People needed

80

Starts

2011-03-01

Expected to finish

2016-09-01

Last updated by the study team

2018-02-14

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pre- operative exclusion criteria:
• patient undergoing redo-sternotomy.
• patient undergoing emergent surgery (defined as life-threatening 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.

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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