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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03667235

Acronym

10vs20-OZAKI

Enrollment

Registered

2018-09-12

Start date

2017-08-04

Completion date

2019-10-31

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Surgery

Keywords

OZAKI technique

Brief summary

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

Detailed description

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.

Interventions

OTHERTreatment of human pericardium with glutaraldehyde in OZAKI procedure

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

OTHERTreatment of human aortic valve tissue with glutaraldehyde

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
mechanic stability tests to investigate uniaxial and cyclical tensile properties	4 days after surgery	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
thermic stability by using constant force at linearly increasing temperature	4 days after surgery	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)

Secondary

Measure	Time frame	Description
histologic analysis of collagen fiber organization and quantification	4 days after surgery	histologic analysis by Scanning Electrical Microscopy (SEM) and using Picrosirius staining to identify the types I and IV collagen
Pronase testing to analyse enzymatic degradation	4 days after surgery	Pronase testing to analyse enzymatic degradation

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026