10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure

University Hospital, Basel, Switzerland6 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Surgery

Interventions

Treatment of human pericardium with glutaraldehyde in OZAKI procedureOTHER

10 versus 20 minutes treatment of human pericardium with 0.6% glutaraldehyde in OZAKI procedure

Treatment of human aortic valve tissue with glutaraldehydeOTHER

10 versus 20 minutes treatment of human aortic valve tissue with 0.6%glutaraldehyde

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * patients undergoing aortic valve surgery with sufficient leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets) Exclusion Criteria: * denial of consent * insufficient leftover tissues from the OZAKI procedure * patients after thoracic radiation or surgery

Locations (1)

Herzchirurgie University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

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: * uniaxial ultimate tensile strength (UTS) test; * cyclical tensile stretching of the tissue in order to investigate its viscoelastic properties

Time frame: 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)

Time frame: 4 days after surgery

Secondary Outcomes

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

Time frame: 4 days after surgery

Pronase testing to analyse enzymatic degradation

Time frame: 4 days after surgery

Data from ClinicalTrials.gov

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