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Trial registered on ANZCTR


Registration number
ACTRN12616000091404
Ethics application status
Approved
Date submitted
13/01/2016
Date registered
28/01/2016
Date last updated
17/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of a novel Sternal Protection Device to evaluate its safety in 12 patients requiring a cardiothoracic surgery
Scientific title
A pilot study evaluating the safety of a Novel Sternal Protection Device for cardiac surgery involving a median sternotomy incision
Secondary ID [1] 288273 0
01025-00014
Secondary ID [2] 288274 0
Jupiter 101
Universal Trial Number (UTN)
U1111-1178-2964
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sternal bleeding resulting from cardiothoracic surgery requiring median sternotomy 297252 0
Sternal fractures resulting from cardiothoracic surgery requiring median sternotomy 297253 0
Condition category
Condition code
Surgery 297429 297429 0 0
Other surgery
Cardiovascular 297512 297512 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293566 0
Treatment: Devices
Intervention code [2] 293632 0
Treatment: Surgery
Intervention code [3] 293633 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296986 0
Safety of Sternal Protection Device will be evaluated during the cardiac surgery, assessed by the number and severity/seriousness of adverse device events. These assessments are made continuously throughout the surgical procedure by the cardiothoracic surgeon.
Timepoint [1] 296986 0
From placement of SPD to time of removal of SPD
Secondary outcome [1] 319808 0
Ability of the SPD to protect the sternum from trauma will be evaluated. This will be visually assessed by the cardiothoracic surgeon post removal of the sternal protection device and rates according to a 4-point Likert scale.
Timepoint [1] 319808 0
5 minutes after removal of SPD
Secondary outcome [2] 319809 0
Ability of the SPD to protect the sternum from blood loss during the period of the device is in situ will be evaluated. This will be visually assessed by the cardiothoracic surgeon at various required time-points during the surgery and rates according to a 4-point Likert scale.
Timepoint [2] 319809 0
5 mins prior to insertion of SPD; 5 and 10 mins after insertion of IMA; 5 and 30 mins after insertions of Sternal retractor; 5 mins after protamine administered; 5 mins after removal of SPD
Secondary outcome [3] 319810 0
Ease of use of the SPD during the cardiac surgery will be evaluated. This will be rated by the surgeon using a 5-point Likert scale at various stages of the surgery.
Timepoint [3] 319810 0
5 minutes after insertion, 5 minutes after retractor insertion, 5 minutes after removal of SPD

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2016
Actual
11/04/2016
Date of last participant enrolment
Anticipated
6/05/2016
Actual
22/07/2016
Date of last data collection
Anticipated
Actual
23/08/2016
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5016 0
The Alfred - Prahran
Recruitment postcode(s) [1] 12509 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 292663 0
Commercial sector/Industry
Name [1] 292663 0
Protego Medical Pty Ltd
Country [1] 292663 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Protego Medical Pty Ltd
Address
Level 9, 278 Collins Street
Melbourne
Victoria-3000
Country
Australia
Secondary sponsor category [1] 291431 0
None
Name [1] 291431 0
None
Address [1] 291431 0
Nine
Country [1] 291431 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294135 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 294135 0
55 Commercial Road,
Prahran, VIC 3004
Ethics committee country [1] 294135 0
Australia
Date submitted for ethics approval [1] 294135 0
22/01/2015
Approval date [1] 294135 0
01/04/2015
Ethics approval number [1] 294135 0
4/15

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62590 0
A/Prof Silvana Marasco
Address 62590 0
The Alfred,
Department of Cardiothoracic Surgery
55 Commercial Rd,
Prahran, VIC 3004
Country 62590 0
Australia
Phone 62590 0
+61 3 90762000
Fax 62590 0
Email 62590 0
[email protected]
Contact person for public queries
Name 62591 0
Mr Pablo Solis
Address 62591 0
Level 9,
278 Collins Street,
Melbourne VIC 3000
Country 62591 0
Australia
Phone 62591 0
+61 3 96570718
Fax 62591 0
Email 62591 0
[email protected]
Contact person for scientific queries
Name 62592 0
Mr Pablo Solis
Address 62592 0
Level 9,
278 Collins Street,
Melbourne VIC 3000
Country 62592 0
Australia
Phone 62592 0
+61 3 96570718
Fax 62592 0
Email 62592 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.