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10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure (10vs20-OZAKI)

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ClinicalTrials.gov Identifier: NCT03667235
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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

Condition or disease Intervention/treatment
Aortic Valve Surgery Other: Treatment of human pericardium with glutaraldehyde in OZAKI procedure Other: Treatment of human aortic valve tissue with glutaraldehyde

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.

Study Design
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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure
Actual Study Start Date : August 4, 2017
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Glutaral

Groups and Cohorts
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Intervention Details:
  • Other: Treatment of human pericardium with glutaraldehyde in OZAKI procedure
    10 versus 20 minutes treatment of human pericardium with 0.6% glutaraldehyde in OZAKI procedure
  • Other: Treatment of human aortic valve tissue with glutaraldehyde
    10 versus 20 minutes treatment of human aortic valve tissue with 0.6%glutaraldehyde

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing aortic valve surgery with OZAKI technique at Universitätsspital Basel/ Switzerland
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667235


Locations
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Switzerland
Herzchirurgie University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Oliver Reuthebuch, PD Dr. med University Hospital, Basel, Switzerland
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03667235    
Other Study ID Numbers: 2017-01334; ch17Reuthebuch2
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
OZAKI technique
Additional relevant MeSH terms:
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Glutaral
Disinfectants
Anti-Infective Agents