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

Tetyana Leinberger; Claudia Heilmann; Stefan Sorg; Matthias Mueller; Sami Kueri; Claudia Schmoor; Matthias Siepe; Friedhelm Beyersdorf

doi:10.1055/s-0037-1618584

The Thoracic and Cardiovascular Surgeon, Table of Contents

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

¹Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany

²Faculty of Medicine, University of Freiburg, Freiburg, Germany

,

Claudia Heilmann

³Saxon University of Cooperative Education, Plauen, Germany

,

Stefan Sorg

¹Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany

²Faculty of Medicine, University of Freiburg, Freiburg, Germany

,

Matthias Mueller

¹Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany

²Faculty of Medicine, University of Freiburg, Freiburg, Germany

,

Sami Kueri

¹Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany

²Faculty of Medicine, University of Freiburg, Freiburg, Germany

,

Claudia Schmoor

²Faculty of Medicine, University of Freiburg, Freiburg, Germany

⁴Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany

,

Matthias Siepe

¹Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany

²Faculty of Medicine, University of Freiburg, Freiburg, Germany

,

Friedhelm Beyersdorf

¹Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany

²Faculty of Medicine, University of Freiburg, Freiburg, Germany

› Author Affiliations

Abstract

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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.

Keywords

mediastinitis - sternal closure - high-risk patients - sternotomy

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References

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