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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-04

Study Completion Date

2019-10-31

Brief Summary

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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

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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

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Aortic Valve Surgery

Keywords

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OZAKI technique

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Treatment of human pericardium with glutaraldehyde in OZAKI procedure

10 versus 20 minutes treatment of human pericardium with 0.6% glutaraldehyde in OZAKI procedure

Intervention Type OTHER

Treatment of human aortic valve tissue with glutaraldehyde

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

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Reuthebuch, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Herzchirurgie University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2017-01334; ch17Reuthebuch2

Identifier Type: -

Identifier Source: org_study_id