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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
Subjects:
Inclusion criteria:
Pre- operative exclusion criteria:
Intraoperative exclusion criteria:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wire closure is the intervention | Active Comparator | Patients will have their sternum closed using stainless steel wires. |
|
| Rigid fixation | Active Comparator | Patients will have their sternum closed by rigid fixation using Starnalock plates. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sternalock Rigid Fixation | Device | Patients will have their sternum closed by rigid fixation using Sternalock plates. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Length of ICU Stay | Length of postoperative intensive care unit stay. |
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Inclusion Criteria:
Exclusion Criteria:
Pre- operative exclusion criteria:
Intraoperative exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hitoshi Hirose, MD, PhD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Division of Cardiothoracic Surgery, Thomas Jefferson University | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rigid Fixation | Patients will have their sternum closed by rigid fixation using Starnalock plates. Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates. |
| FG001 | Wire Closure is the Intervention | Patients will have their sternum closed using stainless steel wires. Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wire Closure is the Intervention | Patients will have their sternum closed using stainless steel wires. Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates. |
| BG001 | Rigid Fixation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intubation time | Posted | Mean | Standard Deviation | hours | 48 hours after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wire Closure is the Intervention | Patients will have their sternum closed using stainless steel wires. Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep sternal infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One patient developed deep sternal infection. Patient was treated with antibiotics and muscle flap, then eventually discharged from hospital |
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Small number of enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hitoshi Hirose, Professor of Surgery | Thomas Jefferson University | 2159556925 | Hitoshi.Hirose@jefferson.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ICU stay |
| Postop Length of Hospital Stay. | Postoperative length of hospital stay. | Until hospital discharge |
Patients will have their sternum closed by rigid fixation using Starnalock plates. Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pain Scores. | One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5. | Likert Pain Scale from 0-10 (0: no pain; 10:worst possible pain) | Posted | Mean | Standard Deviation | score on a scale | 5 days after surgery |
|
|
|
| Secondary | Length of ICU Stay | Length of postoperative intensive care unit stay. | Postoperative average intensive care unit stay (hours) | Posted | Mean | Standard Deviation | hours | ICU stay |
|
|
|
| Secondary | Postop Length of Hospital Stay. | Postoperative length of hospital stay. | Postoperative length of hospital stay. | Posted | Mean | Standard Deviation | days | Until hospital discharge |
|
|
|
| 1 |
| 41 |
| 1 |
| 41 |
| 0 |
| 41 |
| EG001 | Rigid Fixation | Patients will have their sternum closed by rigid fixation using Starnalock plates. Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates. | 0 | 39 | 1 | 39 | 0 | 39 |
|
| Mortality | Nervous system disorders | Non-systematic Assessment | Mortality due to acute stroke |
|
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| Pain score on day3 |
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| Pain score on day4 |
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| Pain score on day5 |
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