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Improvement of Hemostasis Techniques After Median Sternotomy

NCT01134471 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2010-06-02

No results posted yet for this study

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.

Conditions

  • Sternal Dehiscence
  • Sternal Infection
  • Sternal Pain

Interventions

DEVICE

Ostene

applied to sternal surface

DEVICE

Bonewax

applied to sternal surface

Sponsors & Collaborators

  • Ceremed, Inc.

    collaborator INDUSTRY

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Rikke Vestergaard, MD · Dept. of Cardiothoracic surgery, Aarhus University Hospital, Skejby

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134471 on ClinicalTrials.gov