Improvement of Hemostasis Techniques After Median Sternotomy

Aarhus University Hospital

Status and phase: Unknown; Phase 4

Conditions: Sternal Infection; Sternal Dehiscence; Sternal Pain

Treatments: Device: Ostene; Device: Bonewax

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01134471

Ostene-project

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Male

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups

Control

No Intervention group

Bonewax

Active Comparator group

Description:

Patients treated with the hemostatic bonewax

Treatment:

Device: Bonewax

Ostene

Active Comparator group

Description:

Patients treated with the hemostatic Ostene

Treatment:

Device: Ostene