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

Aortic Valve Surgery Clinical Trial

— 10vs20-OZAKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667235
• Other study ID #: 2017-01334; ch17Reuthebuch2
• Status: Completed
• Start date: August 4, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Surgery

Intervention

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

Locations

Country	Name	City	State
Switzerland	Herzchirurgie University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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