NCT03667235

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

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.

Conditions

• Aortic Valve Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-04
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2018-09-12
• Last updated: 2019-12-10

Locations

1 site across 1 country: Switzerland