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

December 9, 2019 updated by: University Hospital, Basel, Switzerland
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Herzchirurgie University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing aortic valve surgery with OZAKI technique at Universitätsspital Basel/ Switzerland

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 days after surgery
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)
4 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 days after surgery
Pronase testing to analyse enzymatic degradation
Time Frame: 4 days after surgery
Pronase testing to analyse enzymatic degradation
4 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Oliver Reuthebuch, PD Dr. med, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2017

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01334; ch17Reuthebuch2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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