Improvement of Hemostasis Techniques After Median Sternotomy

Aarhus University Hospital75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sternal Dehiscence Sternal Infection Sternal Pain

Interventions

OsteneDEVICE

applied to sternal surface

BonewaxDEVICE

applied to sternal surface

Eligibility

Sex: MALEMin age: 60 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery

Aarhus, Denmark

Outcomes

Primary Outcomes

Bone healing in sternum

Time frame: 6 months after surgery

Questionnaire regarding physical and emotional well being

Time frame: 6 months after surgery

Pain-score (VAS)

Time frame: 6 months

Secondary Outcomes

Blood product consumption

Time frame: 6 months

Mediastinitis

Time frame: 6 months

superficial infection

Time frame: 6 months

Bleeding through the chest tube

Time frame: 6 months

Data from ClinicalTrials.gov

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