Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery

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

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.

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Detailed Description

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Conditions

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C.Surgical Procedure; Cardiac Haemorrhage.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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032-11

032-11 topical haemostat.

Group Type EXPERIMENTAL

032-11

Intervention Type DEVICE

Topical haemostat

Floseal (R)

Floseal(R) topical haemostat

Group Type ACTIVE_COMPARATOR

Floseal (R)

Intervention Type DEVICE

Topical haemostat

Interventions

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032-11

Topical haemostat

Intervention Type DEVICE

Floseal (R)

Topical haemostat

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient must be equal or greater than 18 years old
* The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery
* The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception
* The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks
* The patient must provide written informed consent using a form that is reviewed and approved by the IEC

Exclusion Criteria

* The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period.
* The patient has a known hypersensitivity to materials of bovine origin
* The patient does not wish to receive materials of bovine or shellfish origin for any reason

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No