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Completed

NCT Number: NCT03667235

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

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

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Key information

Conditions

Aortic Valve Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzchirurgie University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. mechanic stability tests to investigate uniaxial and cyclical tensile properties

    Time frame: 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

  2. thermic stability by using constant force at linearly increasing temperature

    Time frame: 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 outcomes

  1. histologic analysis of collagen fiber organization and quantification

    Time frame: 4 days after surgery

    histologic analysis by Scanning Electrical Microscopy (SEM) and using Picrosirius staining to identify the types I and IV collagen

  2. Pronase testing to analyse enzymatic degradation

    Time frame: 4 days after surgery

    Pronase testing to analyse enzymatic degradation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: 10vs20-OZAKI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2018
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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