Improvement of Hemostasis Techniques After Median Sternotomy | NCT01134471

Studies
Improvement of Hemostasis Techniques After Median Sternotomy

NCT01134471

Sponsor

Aarhus University Hospital

Status

Unknown status

Last Update Posted

Jun 2, 2010Estimated

Enrollment

75Actual

Phase

Phase 4

Conditions

Sternal Dehiscence
Sternal Infection
Sternal Pain

Interventions

Ostene
Bonewax

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

May 2011Estimated

Completion Date

May 2011Estimated

First Submitted Date

May 28, 2010

First Submission Date that Met QC Criteria

Jun 1, 2010

First Posted Date

Jun 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2010

Last Update Posted Date

Jun 2, 2010Estimated

Name	Class
Ceremed, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ostene	Device	applied to sternal surface	Ostene
Bonewax

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Blood product consumption		6 months
Mediastinitis		6 months
superficial infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rikke Vestergaard, MD	Dept. of Cardiothoracic surgery, Aarhus University Hospital, Skejby	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery		Aarhus		8200	Denmark