Improvement of Hemostasis Techniques After Median Sternotomy

NCT ID: NCT01134471

Last Updated: 2010-06-02

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to compare 2 different hemostatic agents (Bonewax and Ostene)to a control group with regards to bleeding, bone healing, pain and infection in a patient group all undergoing median sternotomy.

Detailed Description

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Conditions

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Sternal Dehiscence Sternal Infection Sternal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Bonewax

Patients treated with the hemostatic bonewax

Group Type ACTIVE_COMPARATOR

Bonewax

Intervention Type DEVICE

applied to sternal surface

Ostene

Patients treated with the hemostatic Ostene

Group Type ACTIVE_COMPARATOR

Ostene

Intervention Type DEVICE

applied to sternal surface

Interventions

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Ostene

applied to sternal surface

Intervention Type DEVICE

Bonewax

applied to sternal surface

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* men undergoing elective cardiac surgery at the Cardiac surgery department of Aarhus University Hospital, Skejby
* no clopidogrel-treatment
* no osteoporoses
* less than 2 co-morbidities in the form of obesity (BMI\>30), COPD, chronic steroid use, renal failure, immunosuppression and diabetes

Exclusion Criteria

* profuse sternal bleeding
* serious complications to the surgery fx cerebral infarction
* re-operation due to bleeding
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ceremed, Inc.

INDUSTRY

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aarhus University Hospital, Skejby, Cardiothorasic surgery dept.

Principal Investigators

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Rikke Vestergaard, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Cardiothoracic surgery, Aarhus University Hospital, Skejby

Locations

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Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Ostene-project

Identifier Type: -

Identifier Source: org_study_id

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