Sternal DehiscencePhase 4NCT01134471
Improvement of Hemostasis Techniques After Median Sternotomy
A Phase 4 study testing Ostene and Bonewax in people with Sternal Dehiscence and Sternal Infection, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sternal Dehiscence, Sternal Infection, Sternal Pain
- What is being tested?
- Ostene and Bonewax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- profuse sternal bleeding
- serious complications to the surgery fx cerebral infarction
- re-operation due to bleeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery
Aarhus, 8200
About this study
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
- Being tested
- Ostene, Bonewax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteneDevice
applied to sternal surface
BonewaxDevice
applied to sternal surface
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Bonewax | Active comparator | Patients treated with the hemostatic bonewax Receives: Device: Bonewax |
| Ostene | Active comparator | Patients treated with the hemostatic Ostene Receives: Device: Ostene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing in sternum
Measured: 6 months after surgery
Questionnaire regarding physical and emotional well being
Measured: 6 months after surgery
Pain-score (VAS)
Measured: 6 months
Secondary outcomes (4)
Blood product consumption
Measured: 6 months
Mediastinitis
Measured: 6 months
superficial infection
Measured: 6 months
Bleeding through the chest tube
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startApr 2009
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sternal DehiscenceStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ceremed, Inc.
- Investigators
- Rikke Vestergaard, MD, Principal investigator, Dept. of Cardiothoracic surgery, Aarhus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134471
- Sponsor's protocol ID
- Ostene-project
- Status last verified
- May 2010
- First submitted
- 28 May 2010
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Hemostasis Techniques After Median Sternotomy
- ClinicalTrials.gov ID
- NCT01134471
- Acronym / sponsor ID
- Ostene-project
- Conditions
- Sternal Dehiscence, Sternal Infection, Sternal Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Ceremed, Inc.
- Study start
- Apr 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Bonewax | Active comparator | Device: BonewaxPatients treated with the hemostatic bonewax |
| Ostene | Active comparator | Device: OstenePatients treated with the hemostatic Ostene |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- profuse sternal bleeding
- serious complications to the surgery fx cerebral infarction
- re-operation due to bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteneapplied to sternal surface | Device | Ostene |
| Bonewaxapplied to sternal surface | Device | Bonewax |
Primary outcome
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
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikke Vestergaard, MD principal investigator
Dept. of Cardiothoracic surgery, Aarhus University Hospital, Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ostene and Bonewax in people with Sternal Dehiscence and Sternal Infection, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone healing in sternum (time frame: 6 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2010.