Improvement of Hemostasis Techniques After Median Sternotomy

Sternal Infection Clinical Trial

Official title:

Improvement of Hemostasis Techniques After Median Sternotomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01134471
• Other study ID #: Ostene-project
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 28, 2010
• Last updated: June 1, 2010
• Start date: April 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2010
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sternal Dehiscence
• Sternal Infection
• Sternal Pain

Intervention

Device:
• Ostene
applied to sternal surface
• Bonewax
applied to sternal surface

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Ceremed, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone healing in sternum		6 months after surgery	No
Primary	Questionnaire regarding physical and emotional well being		6 months after surgery	No
Primary	Pain-score (VAS)		6 months	No
Secondary	Blood product consumption		6 months	No
Secondary	Mediastinitis		6 months	No
Secondary	superficial infection		6 months	No
Secondary	Bleeding through the chest tube		6 months	No