mediastinitis after median sternotomy M96.81
Conditions
Interventions
Group 1: Closure of median sternotomy by Sternal Talon
Group 2: closure of median sternotomy by wires
Sponsors
Gebrüder Martin GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - planned median sternotomy - at least 18 years old - at least 4 of the following risk factors: age at least 65 years age at least 80 years myocardial infarction within the last 90 days and left-ventricular ejection fraction at or below 35% peripheral arterial disease chronic obstructive pulmonary disease creatinine at or above 200 µmol immunosuppression, cytostatics critical general condition planned utilization of both Aa. mammariae body mass index at or above 30 kg/m² body mass index at or above 40 kg/m²
Exclusion criteria
Exclusion criteria: - hyperresponsiveness to titanium - systemic antibiotic therapy - thoracic anomaly - pregnancy possible, breast-feeding - lacking compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of mediastinitis or sternal instability within the first 30 (+/- 5) days after primary sternal closure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intensity of postoperative pain in the chest area on the first and third postoperative days during the hospitalization period, and on the 7th, 14th, 21st and 30th day in case of continued hospitalization. 2. Incidence of mediastinitis or sternal instability within the first 60 (+/- 5) days after primary sternal closure. 3. Incidence of a transverse sternal fracture during the first 30 (+/- 5) days after primary sternal closure. 4. Incidence of pneumonia during the hospitalization period up to a maximum of 30 days after primary sternal closure | — |
Countries
Austria, Germany
Contacts
Public ContactStefan Sorg
Universitätsklinikum Freiburg Abt. Herz- und Gefäßchirurgie
Outcome results
None listed