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