- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01317095
A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure
Study Overview
Detailed Description
Subjects:
Inclusion criteria:
- 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.
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.
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.
- 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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Wire closure is the intervention
Patients will have their sternum closed using stainless steel wires.
|
Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
ACTIVE_COMPARATOR: Rigid fixation
Patients will have their sternum closed by rigid fixation using Starnalock plates.
|
Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores.
Time Frame: 5 days after surgery
|
One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5.
|
5 days after surgery
|
Length of ICU Stay
Time Frame: ICU stay
|
Length of postoperative intensive care unit stay.
|
ICU stay
|
Postop Length of Hospital Stay.
Time Frame: Until hospital discharge
|
Postoperative length of hospital stay.
|
Until hospital discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hitoshi Hirose, MD, PhD, Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Sternal Closure
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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