Clinical Outcomes in Patients Treated With SternaLock Blu

NCT03709693 | Terminated FDA Device

• 1 other identifier: 0518
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Cardiac Surgical Procedures; Coronary Artery Disease; Heart Valve Diseases

Keywords

sternotomy; rigid fixation; sternal fixation; sternal plating

Outcome Measures

Primary Outcomes (1)

• 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: 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

  at 30 days post operatively up to 90 days

Study Arms (1)

SternaLock Blu

All patients will receive SternaLock Blu for closure of full mid-line sternotomy.

Device: SternaLock Blu

Interventions

SternaLock Blu DEVICE

Sternal closure will be accomplished using SternaLock Blu plates and screws in combination with single-wire method of sternal reduction.

SternaLock Blu

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

2000 subjects total (+/- 20) from up to 20 sites

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

St. Franciscan Health

Indianapolis, Indiana, 46032, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Cardiovascular Surgery Clinic, PLLC

Memphis, Tennessee, 38120, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (42)

• 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.

  PMID: 24440333 BACKGROUND

• O'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.

  PMID: 19559823 BACKGROUND

• Sharma 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.

  PMID: 14726063 BACKGROUND

• Shifrin 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.

  PMID: 18033747 BACKGROUND

• Song 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.

  PMID: 15296898 BACKGROUND

• RESTORE (2012).

  BACKGROUND

• Quality M (2012).

  BACKGROUND

• 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.

  PMID: 21138917 BACKGROUND

• Gorlitzer 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.

  PMID: 20103509 BACKGROUND

• Fedak 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.

  PMID: 21958795 BACKGROUND

• Dickie 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.

  PMID: 16721085 BACKGROUND

• Clopper CJ (1934) The use of confidcence or fiducial limits illustrated in the case of the binomial. Biometrika 26(4): 404-413.

  BACKGROUND

• CCS

  BACKGROUND

• 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.

  PMID: 10333037 RESULT

• Claes 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.

  PMID: 9379268 RESULT

• D'Agostino RS, Jacobs JP, Badhwar V, Paone G, Rankin JS, Han JM, McDonald D, Shahian DM. The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2016 Update on Outcomes and Quality. Ann Thorac Surg. 2016 Jan;101(1):24-32. doi: 10.1016/j.athoracsur.2015.11.032. Epub 2015 Nov 24.

  PMID: 26616408 RESULT

• Gottlieb LJ, Pielet RW, Karp RB, Krieger LM, Smith DJ Jr, Deeb GM. Rigid internal fixation of the sternum in postoperative mediastinitis. Arch Surg. 1994 May;129(5):489-93. doi: 10.1001/archsurg.1994.01420290035005.

  PMID: 8185470 RESULT

• Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.

  PMID: 17006079 RESULT

• Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. doi: 10.1016/s0003-4975(03)01468-1.

  PMID: 14726062 RESULT

• Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4. doi: 10.1034/j.1399-6576.2001.450804.x.

  PMID: 11576043 RESULT

• Pai S, Gunja NJ, Dupak EL, McMahon NL, Coburn JC, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. A mechanical study of rigid plate configurations for sternal fixation. Ann Biomed Eng. 2007 May;35(5):808-16. doi: 10.1007/s10439-007-9272-3. Epub 2007 Mar 22.

  PMID: 17377844 RESULT

• Raman J, Straus D, Song DH. Rigid plate fixation of the sternum. Ann Thorac Surg. 2007 Sep;84(3):1056-8. doi: 10.1016/j.athoracsur.2006.11.045.

  PMID: 17720442 RESULT

• Sargent LA, Seyfer AE, Hollinger J, Hinson RM, Graeber GM. The healing sternum: a comparison of osseous healing with wire versus rigid fixation. Ann Thorac Surg. 1991 Sep;52(3):490-4. doi: 10.1016/0003-4975(91)90910-i.

  PMID: 1898136 RESULT

• Vassileva CM, Aranki S, Brennan JM, Kaneko T, He M, Gammie JS, Suri RM, Thourani VH, Hazelrigg S, McCarthy P. Evaluation of The Society of Thoracic Surgeons Online Risk Calculator for Assessment of Risk in Patients Presenting for Aortic Valve Replacement After Prior Coronary Artery Bypass Graft: An Analysis Using the STS Adult Cardiac Surgery Database. Ann Thorac Surg. 2015 Dec;100(6):2109-15; discussion 2115-6. doi: 10.1016/j.athoracsur.2015.04.149. Epub 2015 Jul 30.

  PMID: 26233279 RESULT

• STS

  RESULT

• Snyder CW, Graham LA, Byers RE, Holman WL. Primary sternal plating to prevent sternal wound complications after cardiac surgery: early experience and patterns of failure. Interact Cardiovasc Thorac Surg. 2009 Nov;9(5):763-6. doi: 10.1510/icvts.2009.214023. Epub 2009 Aug 26.

  PMID: 19710069 RESULT

• Schimmer C, Sommer SP, Bensch M, Bohrer T, Aleksic I, Leyh R. Sternal closure techniques and postoperative sternal wound complications in elderly patients. Eur J Cardiothorac Surg. 2008 Jul;34(1):132-8. doi: 10.1016/j.ejcts.2008.04.006. Epub 2008 May 9.

  PMID: 18468447 RESULT

• Schimmer C, Reents W, Berneder S, Eigel P, Sezer O, Scheld H, Sahraoui K, Gansera B, Deppert O, Rubio A, Feyrer R, Sauer C, Elert O, Leyh R. Prevention of sternal dehiscence and infection in high-risk patients: a prospective randomized multicenter trial. Ann Thorac Surg. 2008 Dec;86(6):1897-904. doi: 10.1016/j.athoracsur.2008.08.071.

  PMID: 19022005 RESULT

• Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.

  PMID: 17670585 RESULT

• NYHA

  RESULT

• Losanoff JE, Basson MD, Gruber SA, Huff H, Hsieh FH. Single wire versus double wire loops for median sternotomy closure: experimental biomechanical study using a human cadaveric model. Ann Thorac Surg. 2007 Oct;84(4):1288-93. doi: 10.1016/j.athoracsur.2007.05.023.

  PMID: 17888985 RESULT

• Lee JC, Raman J, Song DH. Primary sternal closure with titanium plate fixation: plastic surgery effecting a paradigm shift. Plast Reconstr Surg. 2010 Jun;125(6):1720-1724. doi: 10.1097/PRS.0b013e3181d51292.

  PMID: 20517097 RESULT

• JULIAN OC, LOPEZ-BELIO M, DYE WS, JAVID H, GROVE WJ. The median sternal incision in intracardiac surgery with extracorporeal circulation; a general evaluation of its use in heart surgery. Surgery. 1957 Oct;42(4):753-61. No abstract available.

  PMID: 13467646 RESULT

• Hirose H, Yamane K, Youdelman BA, Bogar L, Diehl JT. Rigid sternal fixation improves postoperative recovery. Open Cardiovasc Med J. 2011;5:148-52. doi: 10.2174/1874192401105010148. Epub 2011 Jul 4.

  PMID: 21760857 RESULT

• Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3. doi: 10.3109/09638288809164103.

  PMID: 3403500 RESULT

• Cohen DJ, Griffin LV. A biomechanical comparison of three sternotomy closure techniques. Ann Thorac Surg. 2002 Feb;73(2):563-8. doi: 10.1016/s0003-4975(01)03389-6.

  PMID: 11845875 RESULT

• Chou SS, Sena MJ, Wong MS. Use of SternaLock plating system in acute treatment of unstable traumatic sternal fractures. Ann Thorac Surg. 2011 Feb;91(2):597-9. doi: 10.1016/j.athoracsur.2010.07.083.

  PMID: 21256325 RESULT

• Biomet (2012). SternaLock Blu Primary Closure System Brochure. Biomet Microfixation.

  RESULT

• Bennett-Guerrero E, Phillips-Bute B, Waweru PM, Gaca JG, Spann JC, Milano CA. Pilot study of sternal plating for primary closure of the sternum in cardiac surgical patients. Innovations (Phila). 2011 Nov;6(6):382-8. doi: 10.1097/IMI.0b013e318248fbda.

  PMID: 22436774 RESULT

• Atkins, Z. B., & Wolfe, W. G. (2012). Sternal wound complications following cardiac surgery. In Special Topics in Cardiac Surgery. InTech.

  RESULT

• Allen KB, Thourani VH, Naka Y, Grubb KJ, Grehan J, Patel N, Guy TS, Landolfo K, Gerdisch M, Bonnell M, Cohen DJ. Rigid Plate Fixation Versus Wire Cerclage: Patient-Reported and Economic Outcomes From a Randomized Trial. Ann Thorac Surg. 2018 May;105(5):1344-1350. doi: 10.1016/j.athoracsur.2017.12.011. Epub 2018 Jan 11.

  PMID: 29337126 RESULT

• Allen KB, Thourani VH, Naka Y, Grubb KJ, Grehan J, Patel N, Guy TS, Landolfo K, Gerdisch M, Bonnell M, Cohen DJ. Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage. J Thorac Cardiovasc Surg. 2017 Apr;153(4):888-896.e1. doi: 10.1016/j.jtcvs.2016.10.093. Epub 2016 Nov 17.

  PMID: 27923485 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Keith Allen, MD

  St. Luke's Hospital

  PRINCIPAL INVESTIGATOR

• Marc Gerdisch, MD

  St Franciscan Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 17, 2018
• Study Start: May 14, 2019
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)