Thorac Cardiovasc Surg 2018; 66(06): 508-516
DOI: 10.1055/s-0037-1618584
Original Thoracic
Georg Thieme Verlag KG Stuttgart · New York

The COSTA Study: Sternal Closure in High-Risk Patients - A Prospective Randomized Multicenter Trial

Tetyana Leinberger
1   Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany
2   Faculty of Medicine, University of Freiburg, Freiburg, Germany
,
Claudia Heilmann
3   Saxon University of Cooperative Education, Plauen, Germany
,
Stefan Sorg
1   Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany
2   Faculty of Medicine, University of Freiburg, Freiburg, Germany
,
Matthias Mueller
1   Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany
2   Faculty of Medicine, University of Freiburg, Freiburg, Germany
,
Sami Kueri
1   Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany
2   Faculty of Medicine, University of Freiburg, Freiburg, Germany
,
Claudia Schmoor
2   Faculty of Medicine, University of Freiburg, Freiburg, Germany
4   Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany
,
Matthias Siepe
1   Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany
2   Faculty of Medicine, University of Freiburg, Freiburg, Germany
,
Friedhelm Beyersdorf
1   Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany
2   Faculty of Medicine, University of Freiburg, Freiburg, Germany
› Author Affiliations
Funding This trial was supported by “Gebrüder Martin GmbH & Co. KG,” 78532 Tuttlingen, Germany. The implant systems were also sponsored. The authors had full control of the design of the study, methods used, outcome parameters and results, analysis of data, and production of the written report.

Clinical Registration Number German Clinical Trials Register (DRKS): DRKS00000697.
Further Information

Publication History

28 September 2017

15 November 2017

Publication Date:
02 February 2018 (online)

Abstract

Background Median sternotomy in patients with risk factors for wound healing is associated with high rates of postoperative wound infections and sternum instability.

Methods A total of 338 patients with elective first median sternotomy and at least four predefined risk factors were randomized between Sternal Talon (Gebrüder Martin GmbH & Co. KG—KLS Martin Group, Tuttlingen, Germany) and wire cerclage. The primary end point was mediastinitis and/or sternal instability within 30 ± 5 days, and the secondary end points were mediastinitis and/or sternal instability within 60 ± 5 days; incidence of pneumonia during hospitalization within the first 30 (±5) days and chest pain intensity.

Results The primary end point was reached in 10 Sternal Talon and 7 wire cerclage patients (6.2 vs. 4.7%, odds ratio [OR]: 1.3, 95% confidence interval [CI]: 0.5–3.6, p = 0.57) from 338 randomized patients. Sternal Talon group, n = 170 patients versus wire cerclage group, n = 168 patients. The differences between treatment groups with regard to the incidence of mediastinitis/sternum instability within the first 60 (±5) days after the primary sternum closure and the incidence of pneumonia during the hospitalization within the first 30 (±5) days were not statistically significant, either. We observed comparable rates of superficial surgical site infection (SSI) in Sternal Talon and wire cerclage patients (16.1 vs. 12.1%, OR: 1.4, 95% CI: 0.7–2.7, p = 0.31).

Conclusion According to these data, there is no statistically significant difference between Sternal Talon closure and wire cerclage in reducing the incidence of mediastinitis and superficial SSI after primary closure of median sternotomy in high-risk patients.

Note

This work was presented at the annual meeting of the DGTHG, Leipzig, Germany, February 7, 2016.


Supplementary Material

 
  • References

  • 1 Schimmer C, Reents W, Berneder S. , et al. Prevention of sternal dehiscence and infection in high-risk patients: a prospective randomized multicenter trial. Ann Thorac Surg 2008; 86 (06) 1897-1904
  • 2 Schimmer C, Reents W, Elert O. Primary closure of median sternotomy: a survey of all German surgical heart centers and a review of the literature concerning sternal closure technique. Thorac Cardiovasc Surg 2006; 54 (06) 408-413
  • 3 Heilmann C, Stahl R, Schneider C. , et al. Wound complications after median sternotomy: a single-centre study. Interact Cardiovasc Thorac Surg 2013; 16 (05) 643-648
  • 4 Fowler Jr VG, O'Brien SM, Muhlbaier LH, Corey GR, Ferguson TB, Peterson ED. Clinical predictors of major infections after cardiac surgery. Circulation 2005; 112 (9, Suppl): I358-I365
  • 5 Nazerali RS, Hinchcliff K, Wong MS. Rigid fixation for the prevention and treatment of sternal complications. Ann Plast Surg 2014; 72 (Suppl. 01) S27-S30
  • 6 Alhalawani AM, Towler MR. A review of sternal closure techniques. J Biomater Appl 2013; 28 (04) 483-497
  • 7 de Bucourt M, Swierzy M, Ismail M, Gregor J, Webler M, Rückert JC. A novel sternal closure technique with implants suitable for complex dehiscences. Surg Innov 2010; 17 (04) 353-355
  • 8 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; 6 (06) 382-388
  • 9 Levin LS, Miller AS, Gajjar AH. , et al. An innovative approach for sternal closure. Ann Thorac Surg 2010; 89 (06) 1995-1999
  • 10 Subramaniam T, Keita L, Veerasingam D. Sternal Talon, a novel repair for sternal dehiscence. Kardiochir Torakochirurgia Pol 2015; 12 (02) 153-154
  • 11 Rothstein W, Spata T, Whitson B, Kilic A. Multidimensional sternal fixation to overcome a “floating” sternum. Case Rep Surg 2014; 2014 (14) 690160
  • 12 DeLong MR, Hughes DB, Gaca JG. , et al. Sternal Talon offers a solution for secondary sternum osteosynthesis in patients with nonunion. Ann Thorac Surg 2014; 98 (05) 1804-1808
  • 13 Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. ; Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Guideline for prevention of surgical site infection, 1999. Am J Infect Control 1999; 27 (02) 97-132 , quiz 133–134, discussion 96
  • 14 Raman J, Lehmann S, Zehr K. , et al. Sternal closure with rigid plate fixation versus wire closure: a randomized controlled multicenter trial. Ann Thorac Surg 2012; 94 (06) 1854-1861
  • 15 Fawzy H, Osei-Tutu K, Errett L. , et al. Sternal plate fixation for sternal wound reconstruction: initial experience (retrospective study). J Cardiothorac Surg 2011; 6: 63
  • 16 Friberg O, Dahlin L-G, Söderquist B, Källman J, Svedjeholm R. Influence of more than six sternal fixation wires on the incidence of deep sternal wound infection. Thorac Cardiovasc Surg 2006; 54 (07) 468-473
  • 17 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; 34 (01) 132-138
  • 18 Schimmer C, Gross J, Ramm E. , et al. Prevention of surgical site sternal infections in cardiac surgery: a two-centre prospective randomized controlled study. Eur J Cardiothorac Surg 2017; 51 (01) 67-72
  • 19 Nikolaidis N, Karangelis D, Mattam K, Tsang G, Ohri S. The use of nitinol clips for primary sternal closure in cardiac surgery. Ann Thorac Cardiovasc Surg 2013; 19 (04) 330-334
  • 20 Tsunekawa T, Usui A, Oshima H. , et al. A bioresorbable osteosynthesis device can induce an earlier sternal fusion after median sternotomy. Interact Cardiovasc Thorac Surg 2012; 15 (03) 377-381
  • 21 Srivastava V, Yap C-H, Burdett C, Smailes T, Kendall S, Akowuah E. Thermoreactive clips do not reduce sternal infection: a propensity-matched comparison with sternal wires. Interact Cardiovasc Thorac Surg 2015; 21 (06) 699-704