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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317095
• Other study ID #: Sternal Closure
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: January 16, 2018
• Start date: March 2011
• Est. completion date: September 2016

Study information

• Verified date: January 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Sternalock Rigid Fixation
Patients will have their sternum closed by rigid fixation using Sternalock plates.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation Time	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	48 hours after surgery
Secondary	Pain Scores.	One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5.	5 days after surgery
Secondary	Length of ICU Stay	Length of postoperative intensive care unit stay.	ICU stay
Secondary	Postop Length of Hospital Stay.	Postoperative length of hospital stay.	Until hospital discharge

External Links

•   Division of Cardiothoracic Surgery, Thomas Jefferson University