A pilot study of a novel Sternal Protection Device to evaluate its safety in 12 patients requiring a cardiothoracic surgery
- Conditions
- Sternal bleeding resulting from cardiothoracic surgery requiring median sternotomySternal fractures resulting from cardiothoracic surgery requiring median sternotomySurgery - Other surgeryCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12616000091404
- Lead Sponsor
- Protego Medical Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1) Patients must be assessed as requiring cardiac surgery via a median sternotomy incision by a cardiothoracic surgeon
2) Site personnel must obtain written informed consent from the patient prior to any study procedures (including screening procedures)
1) Patients who require emergency cardiac surgery
2) Patients who have undergone previous surgery via a median sternotomy incision
3) Patients who have any significant thoracic deformity including pectus excavatum, pectus carinatum
4) Patients where the sternal length (including the manubrium and body of the sternum and excluding the xiphisternum) is <= 130mm or => 175 mm (using an external skin preoperative measurement)
5) Patients who weigh => 110kg
6) Patients with a known bleeding disorder or abnormal coagulation profile
7) Patients who have taken an anti-platelet agent (other than aspirin) or other anticoagulant within 7 days of surgery
8) Concurrent enrolment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of cardiopulmonary bypass support
9) Any other medical condition which in the view of the Investigator is likely to interfere with the study or put the participant at risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method