CABG surgery
Conditions
Interventions
Application of ACF-Matrix haemostat in the LIMA bed during CABG surgery.
Sponsors
Gelita Medical
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 18 years or older; 2. Patients demonstrating signs and symptoms of coronary ischaemia and/or stenosis clinically considered suitable for correction by CABG surgery; 3. Investigator is satisfied that there are no other physical conditions present which would prevent the patient from entering and completing the Study; 4. Patients who are willing to participate in the proposed Study as evidenced by signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients coming in for an emergency CABG procedure; 2. Patients coming in for a re- CABG procedure; 3. Patients participating in another clinical trial; 4. Patients showing clinical signs of local or systemic infection, requiring (immediate intravenous) treatment with antibiotics; 5. Patients suffering from blood coagulation disorders; 6. Known presence of any disease or medical condition which may affect the wound healing process of the target wound (e.g. malignancy, vasculitis, connective tissue disease, immunological disorder); 7. A very poor life expectancy of less than 12 weeks, according to the investigator’s judgement; 8. Known allergy to porcine products; 9. Any physical or mental state that precludes ability to abide by Study criteria; 10. Patients not able to give consent, subsequent to initial informed consent; 11. The patient is pregnant or a nursing mother; 12. Evidence of chronic alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No unexpected post operative events in blood chemistry and no clinical signs and symptoms of tamponade. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduced post operative blood and fluid loss produced by the drains. | — |
Contacts
Public ContactA.M. Bijlstra
Outcome results
None listed