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

NCT03667235 | Completed

• 1 other identifier: 2017-01334; ch17Reuthebuch2
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Valve Surgery

Keywords

OZAKI technique

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  4 days after surgery

Secondary Outcomes (2)

• histologic analysis of collagen fiber organization and quantification

  4 days after surgery

• Pronase testing to analyse enzymatic degradation

  4 days after surgery

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• patients undergoing aortic valve surgery with sufficient leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets)

You may not qualify if:

• denial of consent
• insufficient leftover tissues from the OZAKI procedure
• patients after thoracic radiation or surgery

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Herzchirurgie University Hospital Basel

Basel, 4031, Switzerland

Location

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.

MeSH Terms

Interventions

Glutaral

Intervention Hierarchy (Ancestors)

Aldehydes; Organic Chemicals

Study Officials

• Oliver Reuthebuch, PD Dr. med

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: August 4, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

CH (1)