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

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University Hospital Basel

Status

Completed

Conditions

Aortic Valve Surgery

Treatments

Other: Treatment of human aortic valve tissue with glutaraldehyde
Other: Treatment of human pericardium with glutaraldehyde in OZAKI procedure

Study type

Observational

Funder types

Other

Identifiers

NCT03667235
2017-01334 ch17Reuthebuch2;

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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