NCT01134471

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 2, 2010

Status Verified

May 1, 2010

Enrollment Period

2.1 years

First QC Date

May 28, 2010

Last Update Submit

June 1, 2010

Conditions

Sternal DehiscenceSternal InfectionSternal Pain

Outcome Measures

Primary Outcomes (3)

  • Bone healing in sternum

    6 months after surgery

  • Questionnaire regarding physical and emotional well being

    6 months after surgery

  • Pain-score (VAS)

    6 months

Secondary Outcomes (4)

  • Blood product consumption

    6 months

  • Mediastinitis

    6 months

  • superficial infection

    6 months

  • Bleeding through the chest tube

    6 months

Study Arms (3)

Control

NO INTERVENTION

Bonewax

ACTIVE COMPARATOR

Patients treated with the hemostatic bonewax

Device: Bonewax

Ostene

ACTIVE COMPARATOR

Patients treated with the hemostatic Ostene

Device: Ostene

Interventions

OsteneDEVICE

applied to sternal surface

Ostene
BonewaxDEVICE

applied to sternal surface

Bonewax

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • profuse sternal bleeding
  • serious complications to the surgery fx cerebral infarction
  • re-operation due to bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery

Aarhus, 8200, Denmark

Location

Study Officials

  • Rikke Vestergaard, MD

    Dept. of Cardiothoracic surgery, Aarhus University Hospital, Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2010

First Posted

June 2, 2010

Study Start

April 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 2, 2010

Record last verified: 2010-05

Locations

DK(1)