Clinical Outcomes in Patients Treated With SternaLock Blu

Coronary Artery Disease Clinical Trial

— SECURE  

Official title:

Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03709693
• Other study ID #: 0518
• Status: Terminated
• Start date: May 14, 2019
• Est. completion date: May 13, 2020

Study information

• Verified date: July 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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: 1. Wound opened with excision of tissue 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 156
• Est. completion date: May 13, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. = 18 years of age, no upper limit

2. 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

3. Willing and able to return for follow-up Exclusion Criteria: Preoperative

4. Emergent or salvage cardiac acuity i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia

5. 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

6. Delayed sternal closure required for any reason

7. 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

8. Use of bone wax between the sternal halves

9. Intraoperative death prior to device placement

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Coronary Artery Disease
• Heart Valve Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	St. Franciscan Health	Indianapolis	Indiana
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Cardiovascular Surgery Clinic, PLLC	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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( — View Citation

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):13 — View Citation

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

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. — View Citation

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

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. — View Citation

CCS

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. — View Citation

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. — View Citation

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

Cohen DJ, Griffin LV. A biomechanical comparison of three sternotomy closure techniques. Ann Thorac Surg. 2002 Feb;73(2):563-8. — View Citation

Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3. — View Citation

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.athoracsu — View Citation

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. — View Citation

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. — View Citation

Gorlitzer M, Wagner F, Pfeiffer S, Folkmann S, Meinhart J, Fischlein T, Reichenspurner H, Grabenwöger 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

NYHA

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. — View Citation

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. Epub 2007 Mar 22. — View Citation

Quality M (2012).

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. Epub 2006 Apr 25. — View Citation

Raman J, Straus D, Song DH. Rigid plate fixation of the sternum. Ann Thorac Surg. 2007 Sep;84(3):1056-8. — View Citation

RESTORE (2012).

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Nov 26. Review. — View Citation

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 — View Citation

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. — View Citation

STS

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 — View Citation

* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 30 days post operatively up to 90 days