COSTA - Closure of median sternotomy in high-risk patients with the sternal talon system
Not Applicable
- Conditions
- mediastinitis after median sternotomyJ98.50
- Registration Number
- DRKS00000697
- Lead Sponsor
- Gebrüder Martin GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 338
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
- hyperresponsiveness to titanium
- systemic antibiotic therapy
- thoracic anomaly
- pregnancy possible, breast-feeding
- lacking compliance
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of mediastinitis or sternal instability within the first 30 (+/- 5) days after primary sternal closure
- Secondary Outcome Measures
Name Time Method 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.<br>2.Incidence of mediastinitis or sternal instability within thefirst 60 (+/- 5) days after primary sternal closure.<br>3.Incidence of a transverse sternal fracture during the first 30 (+/- 5) days after primary sternal closure.<br>4.Incidence of pneumonia during the hospitalization period up to a maximum of 30 days after primary sternal closure<br>