None listed
Conditions
Brief summary
The purpose of this first in-man, non-comparative study, is to evaluate the safety of the novel Sternal Protection Device developed by Protego Medical Pty Ltd during cardiac surgeries that require median sternotomy. The device has two identical components, each one will be placed over a hemi-sternal section after the median sternotomy incision but prior to insertion of the Internal Mammary Artery or sternal retractor. The device will kept in situ during the procedure and removed immediately prior to sternal closure. This will be conducted at the Alfred Hospital in just 12 patients. The other objectives of the study are evaluation of ability of this device to protect the sternum from trauma and bleeding, and its ease of use during the surgery.
Interventions
The Jupiter sternal protection device (SPD) is supplied sterile for single use and consists of 2 identical components (a left and a right component). Each component has 2 sides, a soft, foam cushioned fabric intended to contact the sternal medulla and a medical-grade fabric supported by a frame designed to contact the retractor. After the median sternotomy incision but prior to insertion of the sternal retractor, a SPD component is placed over each of the hemi-sternal sections by the cardiothora
The Jupiter sternal protection device (SPD) is supplied sterile for single use and consists of 2 identical components (a left and a right component). Each component has 2 sides, a soft, foam cushioned fabric intended to contact the sternal medulla and a medical-grade fabric supported by a frame designed to contact the retractor. After the median sternotomy incision but prior to insertion of the sternal retractor, a SPD component is placed over each of the hemi-sternal sections by the cardiothoracic surgeon. The special design of the frame enables the SPD to take the shape of hemi-sternal section and holds it firm. The surgeon will visually inspect the adherence of the SPD and will position a SPD compatible retractor over the SPD as per standard surgical practice. Once in place, the SPD will remain in-situ during the procedure and is removed immediately after the retractor is removed and prior to performing sternal closure.
Sponsors
Protego Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Outcome results
None listed