Cardiac Surgical ProceduresSECURENCT03709693
Clinical Outcomes in Patients Treated With SternaLock Blu
An observational study of Cardiac Surgical Procedures and Coronary Artery Disease, run by Zimmer Biomet at 4 sites in United States.
Trial summary
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases
- What is being tested?
- SternaLock Blu
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2019to 13 May 2020
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 2000 subjects total (+/- 20) from up to 20 sites
Who may be able to join
- ≥ 18 years of age, no upper limit
- Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure [i.e., coronary artery bypass graft (CABG) and/ or valve replacement along with other cardiac surgical procedures] and closed with the SternaLock Blu Sternal Closure System
- Willing and able to return for follow-up
Who cannot join
- Preoperative
- Emergent or salvage cardiac acuity i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
- Any contraindication listed in the SternaLock Blu instructions for use (IFU/ Appendix 3) (active infection, foreign body sensitivity, or mental/ neurologic conditions who are unwilling or incapable of following post-operative care instructions) Operative
- Delayed sternal closure required for any reason
- Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation, i.e.: insufficient quantity of sternal bone or compressible sternum indicating poor bone quality, as assessed by the operating surgeon using his or her professional judgment at the time of closure
- Use of bone wax between the sternal halves
- Intraoperative death prior to device placement
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia
Charlottesville, Virginia, 22908
St. Franciscan Health
Indianapolis, Indiana, 46032
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Cardiovascular Surgery Clinic, PLLC
Memphis, Tennessee, 38120
About this study
Official title: Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation. This study will also provide evidence of the clinical performance of SternaLock Blu for up to 90 days using real world evidence methodology. Sternal complications will be reported through 90 days follow up.
Read the detailed description
The primary endpoint for this study is the rate of deep sternal wound infection (DSWI) at 30 days post-operative, following a midline sternotomy closed with SternaLock Blu. DSWI is defined as deep infection involving muscle, bone, and/ or mediastinum requiring operative intervention and has all of the following conditions:
- Wound opened with excision of tissue or re-exploration of mediastinum
- Positive culture unless patient on antibiotics at the time of culture or no culture obtained
- Treatment with antibiotics beyond perioperative prophylaxis
Post-operative sternal wound complications occurring within 90 days post-operative.
Outcomes will be reported up to 90 days after surgery, including data on adverse events associated with the use of SternaLock Blu Sternal Closure System from the moment of implantation to the end-of-study.
- Being tested
- SternaLock Blu
- Keywords
- sternotomy, rigid fixation, sternal fixation, sternal plating
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SternaLock BluDevice
Sternal closure will be accomplished using SternaLock Blu plates and screws in combination with single-wire method of sternal reduction.
| Study group | Role | What they receive |
|---|---|---|
| SternaLock Blu | All patients will receive SternaLock Blu for closure of full mid-line sternotomy. Receives: Device: SternaLock Blu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep Sternal Wound Infection Rate
DSWI is defined as deep infection involving muscle, bone, and/ or mediastinum requiring operative intervention and has all of the following conditions:
- Wound opened with excision of tissue (I\&D) or re-exploration of mediastinum
- Positive culture unless patient on antibiotics at the time of culture or no culture obtained
- Treatment with antibiotics beyond perioperative prophylaxis
Measured: at 30 days post operatively up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start14 May 2019
- Primary completion13 May 2020
- Study completion13 May 2020
Why it stopped: COVID 19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Allen, MD, Principal investigator, St. Luke's HospitalMarc Gerdisch, MD, Principal investigator, St Franciscan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709693
- Sponsor's protocol ID
- 0518
- Acronym
- SECURE
- Status last verified
- Jul 2021
- First submitted
- 16 Oct 2018
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Adams J, Schmid J, Parker RD, Coast JR, Cheng D, Killian AD, McCray S, Strauss D, McLeroy Dejong S, Berbarie R. Comparison of force exerted on the sternum during a sneeze versus during low-, moderate-, and high-intensity bench press resistance exercise with and without the valsalva maneuver in healthy volunteers. Am J Cardiol. 2014 Mar 15;113(6):1045-8. doi: 10.1016/j.amjcard.2013.11.064. Epub 2013 Dec 25.
PubMed 24440333O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S23-42. doi: 10.1016/j.athoracsur.2009.05.056.
PubMed 19559823Sharma R, Puri D, Panigrahi BP, Virdi IS. A modified parasternal wire technique for prevention and treatment of sternal dehiscence. Ann Thorac Surg. 2004 Jan;77(1):210-3. doi: 10.1016/s0003-4975(03)01339-0.
PubMed 14726063Shifrin DA, Sohn SM, Stouffer CW, Hooker RL, Renucci JD. Sternal salvage with rigid fixation in the setting of a massive mediastinal aortic pseudoaneurysm: a case report and review of the literature. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):e17-20. doi: 10.1016/j.bjps.2007.09.022. Epub 2007 Nov 26.
PubMed 18033747Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.
PubMed 15296898RESTORE (2012).
Quality M (2012).
Neaman KC, Blount AL, Kim JA, Renucci JD, Hooker RL. Prophylactic sternal plating with pectoralis advancement flaps after sternotomy in patients with a history of chest irradiation. Interact Cardiovasc Thorac Surg. 2011 Mar;12(3):355-8. doi: 10.1510/icvts.2010.247262. Epub 2010 Dec 7.
PubMed 21138917Gorlitzer M, Wagner F, Pfeiffer S, Folkmann S, Meinhart J, Fischlein T, Reichenspurner H, Grabenwoger M. A prospective randomized multicenter trial shows improvement of sternum related complications in cardiac surgery with the Posthorax support vest. Interact Cardiovasc Thorac Surg. 2010 May;10(5):714-8. doi: 10.1510/icvts.2009.223305. Epub 2010 Jan 26.
PubMed 20103509Fedak PW, Kieser TM, Maitland AM, Holland M, Kasatkin A, Leblanc P, Kim JK, King KM. Adhesive-enhanced sternal closure to improve postoperative functional recovery: a pilot, randomized controlled trial. Ann Thorac Surg. 2011 Oct;92(4):1444-50. doi: 10.1016/j.athoracsur.2011.05.014.
PubMed 21958795Dickie SR, Dorafshar AH, Song DH. Definitive closure of the infected median sternotomy wound: a treatment algorithm utilizing vacuum-assisted closure followed by rigid plate fixation. Ann Plast Surg. 2006 Jun;56(6):680-5. doi: 10.1097/01.sap.0000202825.41069.c3.
PubMed 16721085Clopper CJ (1934) The use of confidcence or fiducial limits illustrated in the case of the binomial. Biometrika 26(4): 404-413.
CCS
Casha AR, Yang L, Kay PH, Saleh M, Cooper GJ. A biomechanical study of median sternotomy closure techniques. Eur J Cardiothorac Surg. 1999 Mar;15(3):365-9. doi: 10.1016/s1010-7940(99)00014-7.
PubMed 10333037Claes L, Augat P, Suger G, Wilke HJ. Influence of size and stability of the osteotomy gap on the success of fracture healing. J Orthop Res. 1997 Jul;15(4):577-84. doi: 10.1002/jor.1100150414.
PubMed 9379268
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence
- ClinicalTrials.gov ID
- NCT03709693
- Acronym / sponsor ID
- SECURE / 0518
- Keywords
- sternotomy, rigid fixation, sternal fixation, sternal plating
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID 19 Pandemic
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 14 May 2019 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation. This study will also provide evidence of the clinical performance of SternaLock Blu for up to 90 days using real world evidence methodology. Sternal complications will be reported through 90 days follow up.
Detailed description
The primary endpoint for this study is the rate of deep sternal wound infection (DSWI) at 30 days post-operative, following a midline sternotomy closed with SternaLock Blu. DSWI is defined as deep infection involving muscle, bone, and/ or mediastinum requiring operative intervention and has all of the following conditions:
- Wound opened with excision of tissue or re-exploration of mediastinum
- Positive culture unless patient on antibiotics at the time of culture or no culture obtained
- Treatment with antibiotics beyond perioperative prophylaxis
Post-operative sternal wound complications occurring within 90 days post-operative.
Outcomes will be reported up to 90 days after surgery, including data on adverse events associated with the use of SternaLock Blu Sternal Closure System from the moment of implantation to the end-of-study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SternaLock Blu | – | Device: SternaLock BluAll patients will receive SternaLock Blu for closure of full mid-line sternotomy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 2000 subjects total (+/- 20) from up to 20 sites
Key inclusion criteria (3 listed)
- ≥ 18 years of age, no upper limit
- Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure [i.e., coronary artery bypass graft (CABG) and/ or valve replacement along with other cardiac surgical procedures] and closed with the SternaLock Blu Sternal Closure System
- Willing and able to return for follow-up
Key exclusion criteria (7 listed)
- Preoperative
- Emergent or salvage cardiac acuity i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
- Any contraindication listed in the SternaLock Blu instructions for use (IFU/ Appendix 3) (active infection, foreign body sensitivity, or mental/ neurologic conditions who are unwilling or incapable of following post-operative care instructions) Operative
- Delayed sternal closure required for any reason
- Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation, i.e.: insufficient quantity of sternal bone or compressible sternum indicating poor bone quality, as assessed by the operating surgeon using his or her professional judgment at the time of closure
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 BluSternal closure will be accomplished using SternaLock Blu plates and screws in combination with single-wire method of sternal reduction. | Device | SternaLock Blu |
Primary outcome
Deep Sternal Wound Infection Rate
Time frame: at 30 days post operatively up to 90 days
DSWI is defined as deep infection involving muscle, bone, and/ or mediastinum requiring operative intervention and has all of the following conditions: 1. Wound opened with excision of tissue (I\&D) or re-exploration of mediastinum 2. Positive culture unless patient on antibiotics at the time of culture or no culture obtained 3. Treatment with antibiotics beyond perioperative prophylaxis
Results and safety
The study was stopped early (reason given: COVID 19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Background: PubMed 24440333Adams J, Schmid J, Parker RD, Coast JR, Cheng D, Killian AD, McCray S, Strauss D, McLeroy Dejong S, Berbarie R. Comparison of force exerted on the sternum during a sneeze versus during low-, moderate-, and high-intensity bench press resistance exercise with and without the valsalva maneuver in healthy volunteers. Am J Cardiol. 2014 Mar 15;113(6):1045-8. doi: 10.1016/j.amjcard.2013.11.064. Epub 2013 Dec 25.
- Background: PubMed 19559823O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S23-42. doi: 10.1016/j.athoracsur.2009.05.056.
- Background: PubMed 14726063Sharma R, Puri D, Panigrahi BP, Virdi IS. A modified parasternal wire technique for prevention and treatment of sternal dehiscence. Ann Thorac Surg. 2004 Jan;77(1):210-3. doi: 10.1016/s0003-4975(03)01339-0.
- Background: PubMed 18033747Shifrin DA, Sohn SM, Stouffer CW, Hooker RL, Renucci JD. Sternal salvage with rigid fixation in the setting of a massive mediastinal aortic pseudoaneurysm: a case report and review of the literature. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):e17-20. doi: 10.1016/j.bjps.2007.09.022. Epub 2007 Nov 26.
- Background: PubMed 15296898Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.
- BackgroundRESTORE (2012).
- BackgroundQuality M (2012).
- Background: PubMed 21138917Neaman KC, Blount AL, Kim JA, Renucci JD, Hooker RL. Prophylactic sternal plating with pectoralis advancement flaps after sternotomy in patients with a history of chest irradiation. Interact Cardiovasc Thorac Surg. 2011 Mar;12(3):355-8. doi: 10.1510/icvts.2010.247262. Epub 2010 Dec 7.
- Background: PubMed 20103509Gorlitzer M, Wagner F, Pfeiffer S, Folkmann S, Meinhart J, Fischlein T, Reichenspurner H, Grabenwoger M. A prospective randomized multicenter trial shows improvement of sternum related complications in cardiac surgery with the Posthorax support vest. Interact Cardiovasc Thorac Surg. 2010 May;10(5):714-8. doi: 10.1510/icvts.2009.223305. Epub 2010 Jan 26.
- Background: PubMed 21958795Fedak PW, Kieser TM, Maitland AM, Holland M, Kasatkin A, Leblanc P, Kim JK, King KM. Adhesive-enhanced sternal closure to improve postoperative functional recovery: a pilot, randomized controlled trial. Ann Thorac Surg. 2011 Oct;92(4):1444-50. doi: 10.1016/j.athoracsur.2011.05.014.
- Background: PubMed 16721085Dickie SR, Dorafshar AH, Song DH. Definitive closure of the infected median sternotomy wound: a treatment algorithm utilizing vacuum-assisted closure followed by rigid plate fixation. Ann Plast Surg. 2006 Jun;56(6):680-5. doi: 10.1097/01.sap.0000202825.41069.c3.
- BackgroundClopper CJ (1934) The use of confidcence or fiducial limits illustrated in the case of the binomial. Biometrika 26(4): 404-413.
- Individual participant dataSharing planned: No
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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.
Keith Allen, MD principal investigator
St. Luke's Hospital
Marc Gerdisch, MD principal investigator
St Franciscan Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedures and Coronary Artery Disease, run by Zimmer Biomet at 4 sites 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: COVID 19 Pandemic). Results are not available in the source record.
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?
Deep Sternal Wound Infection Rate (time frame: at 30 days post operatively up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709693, which also lists 42 linked publications.
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 23 Jul 2021.