Sternal Dehiscence, Sternal Infection, Sternal Pain
Conditions
Brief summary
The purpose of this study is to compare 2 different hemostatic agents (Bonewax and Ostene)to a control group with regards to bleeding, bone healing, pain and infection in a patient group all undergoing median sternotomy.
Interventions
DEVICEOstene
applied to sternal surface
DEVICEBonewax
applied to sternal surface
Sponsors
Ceremed, Inc.
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* men undergoing elective cardiac surgery at the Cardiac surgery department of Aarhus University Hospital, Skejby * no clopidogrel-treatment * no osteoporoses * less than 2 co-morbidities in the form of obesity (BMI\>30), COPD, chronic steroid use, renal failure, immunosuppression and diabetes
Exclusion criteria
* profuse sternal bleeding * serious complications to the surgery fx cerebral infarction * re-operation due to bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone healing in sternum | 6 months after surgery |
| Questionnaire regarding physical and emotional well being | 6 months after surgery |
| Pain-score (VAS) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Blood product consumption | 6 months |
| Bleeding through the chest tube | 6 months |
| Mediastinitis | 6 months |
| superficial infection | 6 months |
Countries
Denmark
Outcome results
None listed