PainNCT01317095
A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
A study testing Sternalock Rigid Fixation in people with Pain, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pain
- What is being tested?
- Sternalock Rigid Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure
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
Read the 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)
- Conditions
- Pain
- Being tested
- Sternalock Rigid Fixation
- Keywords
- Rigid fixation, Sternal closure, Open heart surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sternalock Rigid FixationDevice
Patients will have their sternum closed by rigid fixation using Sternalock plates.
| Study group | Role | What they receive |
|---|---|---|
| Wire closure is the intervention | Active comparator | Patients will have their sternum closed using stainless steel wires. Receives: Device: Sternalock Rigid Fixation |
| Rigid fixation | Active comparator | Patients will have their sternum closed by rigid fixation using Starnalock plates. Receives: Device: Sternalock Rigid Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after surgery
Secondary outcomes (3)
Pain Scores.
One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5.
Measured: 5 days after surgery
Length of ICU Stay
Length of postoperative intensive care unit stay.
Measured: ICU stay
Postop Length of Hospital Stay.
Postoperative length of hospital stay.
Measured: Until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hitoshi Hirose, MD, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317095
- Sponsor's protocol ID
- Sternal Closure
- Status last verified
- Jan 2018
- First submitted
- 10 Mar 2011
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure
- ClinicalTrials.gov ID
- NCT01317095
- Acronym / sponsor ID
- Sternal Closure
- Conditions
- Pain
- Keywords
- Rigid fixation, Sternal closure, Open heart surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wire closure is the intervention | Active comparator | Device: Sternalock Rigid FixationPatients will have their sternum closed using stainless steel wires. |
| Rigid fixation | Active comparator | Device: Sternalock Rigid FixationPatients will have their sternum closed by rigid fixation using Starnalock plates. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sternalock Rigid FixationPatients will have their sternum closed by rigid fixation using Sternalock plates. | Device | Rigid fixation, Wire closure is the intervention |
Primary outcome
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
3 secondary outcomes
Pain Scores.
Time frame: 5 days after surgery
Length of ICU Stay
Time frame: ICU stay
Postop Length of Hospital Stay.
Time frame: Until hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Division of Cardiothoracic Surgery, Thomas Jefferson UniversityLink provided by the sponsor.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hitoshi Hirose, MD, PhD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sternalock Rigid Fixation in people with Pain, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation Time (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.