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

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)

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.

Exclusion Criteria:

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.