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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure

Brief 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

Detailed Summary:

  1. Subjects:

    Inclusion criteria:

    1. scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.
    2. patient age ≥18 and <80 .
    3. patient undergoing elective surgery.
    4. 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)
    5. patients who is willing to sign the informed consent to participate the study.

    Pre- operative exclusion criteria:

    1. patient undergoing redo-sternotomy.
    2. patient undergoing emergent surgery (defined as life-threating or unstable condition requiring surgery on the same day of the surgical consultation.)
    3. patients on dialysis
    4. patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.
    5. patients with body mass index ≥ 40.
    6. patients with active endocarditis.
    7. patients with known metal allergy.
    8. patient who refuses consent.
    9. patient who is unable to follow the postoperative instructions.

    Intraoperative exclusion criteria:

      Sponsor: Thomas Jefferson University

      Current Primary Outcome: Intubation time [ Time Frame: 48 hours after surgery ]

      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


      Original Primary Outcome: Same as current

      Current Secondary Outcome: Length of ICU stay, hospital stay and pain scores. [ Time Frame: 1 month after surgery ]

      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.


      Original Secondary Outcome: Same as current

      Information By: Thomas Jefferson University

      Dates:
      Date Received: March 10, 2011
      Date Started: March 2011
      Date Completion:
      Last Updated: January 11, 2017
      Last Verified: January 2017