Improvement of Hemostasis Techniques After Median Sternotomy

June 1, 2010 updated by: Aarhus University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Bonewax
Patients treated with the hemostatic bonewax
Device: Bonewax
applied to sternal surface
Active Comparator: Ostene
Patients treated with the hemostatic Ostene
Device: Ostene
applied to sternal surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone healing in sternum
Time Frame: 6 months after surgery
6 months after surgery
Questionnaire regarding physical and emotional well being
Time Frame: 6 months after surgery
6 months after surgery
Pain-score (VAS)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood product consumption
Time Frame: 6 months
6 months
Mediastinitis
Time Frame: 6 months
6 months
superficial infection
Time Frame: 6 months
6 months
Bleeding through the chest tube
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Ceremed, Inc.

Investigators

  • Principal Investigator: Rikke Vestergaard, MD, Dept. of Cardiothoracic surgery, Aarhus University Hospital, Skejby

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 2, 2010

Last Update Submitted That Met QC Criteria

June 1, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • Ostene-project

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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