A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
Condition: Pain
Study type: Interventional

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 description: 
      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-threatening 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:

             1. osteoporosis or poor quality of sternum.

             2. unstable sternal fracture.

             3. sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined
                by direct measurement.

             4. bilateral mammary artery harvest (causing poor blood supply to the sternum).

             5. patients in whom the chest needs to be left open due to medical reasons.

        2. Procedures:

           Preoperative testing, medical evaluation, cardiac surgery and postoperative care will
           all be performed per standard of care. The patients will sign a separate consent for
           their open heart surgery.

           Baseline screening: Medical history and preoperative testing are reviewed to determine
           if the patient is a suitable candidate of the study. If the patient meets inclusion
           criteria, the study will be explained and the two closure methods will be discussed; it
           will be explained that the method of sternal closure will be determined by randomization
           if they choose to participate in the study. If they still want to participate, the
           consent will be signed.

           Randomization procedure: On the day of heart surgery, subjects will be randomized 1:1 to
           either closure with stainless steel wires or rigid closure with Sternalock System by
           opening an envelope in the operating room. After randomization, if the patient meets any
           of the intraoperative exclusion criteria the patient will be excluded from the study.

           Data collection: Ventilator time, length of intensive care unit stay and length of
           hospital stay will be collected. Daily 6 am pain VAS (visual analog scores) scores will
           be collected while the patient is hospitalized. Complications such as sternal infection,
           sternal dehiscence, pneumonia will be monitored.

           Follow-up visit: At a routine postoperative follow-up visit, usually occurring at 4-8
           weeks after surgery, sternal stability and pain scores will be assessed.

        3. Data analysis:

      Plan is 2 group comparisons using student t-tests or chi-square tests performed to identify
      the factors contributing to intubation time, ICU stay and hospital stay. Univariate analysis
      followed by multivariate analyses to identify independent risk factor will be performed by
      statistical package (JMP software)
    

Intervention name(s): Sternalock Rigid Fixation
Intervention type(s): Device
Intervention description(s): Patients will have their sternum closed by rigid fixation using Sternalock plates.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rigid fixation; Sternal closure; Open heart surgery