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To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes
Autologous pericardium for aortic valve reconstruction is treated with 0.6% glutaraldehyde for 10 minutes to improve stability (OKAZI technique).
This study investigates whether treatment with 0.6% glutaraldehyde for 20 minutes improves mechanic and thermic stability of autologous pericardial tissue. Autologous pericardium remaining after aortic valve reconstruction surgery is used.
To investigate 10 versus 20 minutes treatment of removed original aortic valve tissue with glutaraldehyde as a reference.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment of human pericardium with glutaraldehyde in OZAKI procedure | Other | 10 versus 20 minutes treatment of human pericardium with 0.6% glutaraldehyde in OZAKI procedure | ||
| Treatment of human aortic valve tissue with glutaraldehyde | Other | 10 versus 20 minutes treatment of human aortic valve tissue with 0.6%glutaraldehyde |
| Measure | Description | Time Frame |
|---|---|---|
| mechanic stability tests to investigate uniaxial and cyclical tensile properties | mechanical tests include the use of a universal test machine (MTS Bionix, Department of Bioengineering of Universitaetsspital Basel) for:
| 4 days after surgery |
| thermic stability by using constant force at linearly increasing temperature | constant force at linearly increasing temperature: Thermal stability tests will be conducted on 20 x 4 mm stripes by the imposition of a constant load (approximately 1N) submerged in a saline-solution bath. The temperature of the bath will be increased at a rate of approximately 2.5-5 °C/min, and the sample cross-section will be measured by means of a high-resolution camera (Canon EOS, Japan) | 4 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| histologic analysis of collagen fiber organization and quantification | histologic analysis by Scanning Electrical Microscopy (SEM) and using Picrosirius staining to identify the types I and IV collagen | 4 days after surgery |
| Pronase testing to analyse enzymatic degradation |
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Inclusion Criteria:
Exclusion Criteria:
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patients undergoing aortic valve surgery with OZAKI technique at Universitätsspital Basel/ Switzerland
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Reuthebuch, PD Dr. med | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzchirurgie University Hospital Basel | Basel | 4031 | Switzerland |
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Leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets) will be fixed in glutaraldehyde in the operation room and stored in sterile tubes in Phosphate Buffered Saline(PBS) and transferred at room temperature to the lab where it will be stored in a lab fridge at 4°C.
Pronase testing to analyse enzymatic degradation |
| 4 days after surgery |
| ID | Term |
|---|---|
| D005976 | Glutaral |
| ID | Term |
|---|---|
| D000447 | Aldehydes |
| D009930 | Organic Chemicals |
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