Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001422718p
Ethics application status
Submitted, not yet approved
Date submitted
30/10/2022
Date registered
7/11/2022
Date last updated
7/11/2022
Date data sharing statement initially provided
7/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the safety and efficacy of sternal closure with the Waston Sternal Claw Fixation System for Cardiothoracic Surgical Patients
Scientific title
An Investigator Led Trial to Assess the Safety and Efficacy of the Waston Sternal Claw Fixation System against Standard of Care Wire Cerclage as an Advantageous Method of Median Sternotomy Closure
Secondary ID [1] 308309 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiothoracic Surgery 328093 0
Median Sternotomy 328094 0
Condition category
Condition code
Surgery 325149 325149 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a study to assess the safety and efficacy of the Waston Sternal Claw Fixation System device. The safety and efficacy of the device will be assessed by randomising cardiothoracic surgery patients into different sternal closure intervention arms (Group A - 4 Waston Sternal Claw Devices, Group B - 2 Waston Sternal Claw Devices and Sternal Wires, or Group C - Sternal Wires only) and comparing their outcomes post intervention.

The intervention being assess (Sternal Claw) will be performed by the operating Cardiothoracic Surgeon and will involve the surgeon firstly measuring the width of the sternum and selecting an appropriate Claw Plate size to match the participants sternum size. The appropriate claw plate is attached to a dedicated sternal closure device and hooked into the opposing intercostal spaces. The sternal closure device is tightened closing the sternum and locking the claw plate into place. The sternal closure device is removed leaving the claw plate in place and the sternum in a fully compressed and closed state. This process is repeated for however many claw plates the participant has been randomised to and the whole process is expected to take approximately 10 minutes.

The safety and the efficacy of the Waston Sternal Claw Fixation System will be assessed post-intervention and will involve questionnaires to assess participants pain level and quality of life after intervention, and procedures, including sternal instability scale and ultrasound, to assess sternal union, healing, movement and instability up to 6 weeks post-intervention. These outcome measures will be the same for all arms of the trial.
Intervention code [1] 324759 0
Treatment: Devices
Intervention code [2] 324760 0
Treatment: Surgery
Comparator / control treatment
Sternal wires will be used as the comparator arm for the trial. Sternal closure using sternal wires will involve the operating surgeon running sternal wires around the sternum in the intercostal spaces, pulling them through so both ends are exposed to the surgeon. The adjacent wires are wrapped around each other tightening the wires and closing the sternum. The exposed ends of the wires will be flattened out. This process is expected to take approximately 10-20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 332976 0
The primary outcome of this study is sternal movement assessed by maximal bone edge displacement during coughing through ultrasonography imaging 6 weeks post-surgery between patients receiving Waston claw (groups A and B) and control (Group C).
Timepoint [1] 332976 0
6 weeks post-surgery
Secondary outcome [1] 415386 0
Sternal movement assessed by maximal bone edge displacement during coughing through ultrasonography imaging 6 weeks post-surgery between groups A and B.
Timepoint [1] 415386 0
6 weeks post-surgery
Secondary outcome [2] 415387 0
Post-operative functional status and quality of life assessed as a composite outcome by the functional difficulties questionnaire from baseline through 6 weeks post-surgery between patients receiving Waston Claw (Groups A and B) and control (Group C).
Timepoint [2] 415387 0
6 weeks post-surgery
Secondary outcome [3] 415388 0
Sternal stability and Safety assessed by sternal instability scale from the time of application through 6 weeks post-surgery between patients receiving Waston Claw (Group A and B) and control (Group C).
Timepoint [3] 415388 0
6 weeks post-surgery
Secondary outcome [4] 415539 0
Post-operative sternotomy pain reported by the patient through the visual analogue scale from time of application through 6 weeks post-surgery between patients receiving Waston Claw (Group A and B) and control (Group C).
Timepoint [4] 415539 0
6 weeks post-surgery
Secondary outcome [5] 415540 0
Length of hospital stay, readmission, discharge to nursing facility and death up to 30 days after surgery assessed as an composite secondary outcome by review of medical records between patients receiving Waston Claw (Group A and B) and control (group C).
Timepoint [5] 415540 0
6 weeks post-surgery
Secondary outcome [6] 415541 0
Incidence of sternal wound infection through 6 weeks post-surgery assessed by review of medical records between patients receiving Waston Claw (Group A and B) and control (Group C).
Timepoint [6] 415541 0
6 weeks post-surgery.
Secondary outcome [7] 415542 0
Healthcare-related financial costs will be assessed by sourcing and reviewing hospital financial records between patients receiving Waston Claw (Group A and B) and control (Group C).
Timepoint [7] 415542 0
6 weeks post-surgery.
Secondary outcome [8] 415543 0
Post-operative functional status and quality of life assessed as a composite outcome by the functional difficulties questionnaire from baseline through 6 weeks post-surgery between patients receiving Waston Claw in Group A and Group B.
Timepoint [8] 415543 0
6 weeks post-surgery.
Secondary outcome [9] 415544 0
Sternal stability and Safety assessed by sternal instability scale scale from time of application through 6 weeks post-surgery between patients receiving Waston Claw in Groups A and B
Timepoint [9] 415544 0
6 weeks post-surgery.
Secondary outcome [10] 415545 0
Post-operative sternotomy pain reported by the patient through the visual analogue scale from time of application through 6 weeks post-surgery between patients receiving Waston Claw in Groups A and Group B
Timepoint [10] 415545 0
6 weeks post-surgery.
Secondary outcome [11] 415546 0
Length of hospital stay, readmission, discharge to nursing facility and death up to 30 days after surgery assessed as an composite secondary outcome by review of medical records between patients receiving Waston Claw in Group A and Group B.
Timepoint [11] 415546 0
6 weeks post-surgery.
Secondary outcome [12] 415547 0
Incidence of sternal wound infection through 6 weeks post-surgery assessed by review of medical records between patients receiving Waston Claw in Group A and Group B.
Timepoint [12] 415547 0
6 weeks post-surgery.
Secondary outcome [13] 415548 0
Healthcare-related financial costs will be assessed by sourcing and reviewing hospital financial records between patients receiving Waston Claw in Group A and Group B.
Timepoint [13] 415548 0
6 weeks post-surgery.

Eligibility
Key inclusion criteria
- Patients who undergo median sternotomy for any cardiac procedure
- Patients aged 18-80
- Patients who have sufficient English language
- Patients able to and willing to comply with all study procedures
- Patient able to understand and provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients allergic to heavy alloy
- Patients undergoing re-do procedure
- Patients who have chronic steroid or narcotic use
- Patients with a clinical sternal deformity
- Pregnant women
- Patients with a body mass index greater than or equal to 40
- Patients with severe chronic obstructive airway disease
- Patients with dialysis dependent renal failure.
- Patients who have any of the following Sternal Claw contraindications:
o Severe mental disorder
o Generalized nervous disease
o Immune suppression disorder
o Calcified tissue metabolism disorder
o Systematic or local infections
o Allergic to metal materials

Intra-Operative criteria
- Any intra-operative condition that would preclude the use of the Sternal Claw as deemed appropriate by the treating surgeon
o poor bone quality
o paramedian (non midline) sternotomy
o bleeding (or high likelihood of depending on case specific issues)
o Sizing/technical suitability for CLAW plating system or concerns around use of routine sternal wires
o Other surgical complications as assessed by operating surgeon

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised into the study using a computer-generated code with a block randomisation process
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 90 patients (n=30 per study group) will be recruited into the study The sample size for the study was determined by STATA v15, for a two-sample hypothesis using Pearson’s Chi-Squared. Study parameters were set at with alpha 0.05, power 0.800, delta 0.28 (p, 0.04, p2 0.032) and a fractional sample size of 2:1 (experimental to control). The fractional sample size is based upon 2 experimental groups expected to show similar results and event relationship based upon Royse et al. Interactive CardioVascular and Thoracic Surgery 30 (2020) 863-870

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
Date of last participant enrolment
Anticipated
8/01/2024
Actual
Date of last data collection
Anticipated
19/02/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23514 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 38922 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 312556 0
Commercial sector/Industry
Name [1] 312556 0
Perios Medical Devices Pty. Ltd.
Country [1] 312556 0
Australia
Primary sponsor type
Individual
Name
Professor Jayme Bennetts
Address
Flinders Medical Centre, Cardiothoracic Surgical Unit, Level 6, 1 Flinders Drive, Bedford Park, SA, 5042
Country
Australia
Secondary sponsor category [1] 314160 0
None
Name [1] 314160 0
Address [1] 314160 0
Country [1] 314160 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311883 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 311883 0
1 Flinders Drive, Bedford Park, SA, 5042
Ethics committee country [1] 311883 0
Australia
Date submitted for ethics approval [1] 311883 0
30/10/2022
Approval date [1] 311883 0
Ethics approval number [1] 311883 0

Summary
Brief summary
This is an Investigator led trial to assess the safety and efficacy of the Waston Sternal Claw Fixation System against Standard of Care Wire Cerclage as an advantageous of Median Sternotomy Closure.

Wire cerclage has long been the gold standard and lone method of median sternotomy closure, yet this method has substantial and obvious limitations that can cause patients considerable complications post-procedure. The use of the Waston Sternal Claw Plate has been proposed as an advantageous method of sternal closure compared to all previous closure methods due to the structure of the device, however there has only been one study evaluating the effectiveness of the Waston Sternal Claw as a method of sternotomy closure against wire cerclage. As such, the purpose of this research is to justify the use of the sternal claw system as an improved method for median sternotomy closure and provide additional evidence of its benefit to patient outcomes post-sternotomy.

Participants planned for Cardiac Surgery involving a Median Sternotomy method of heart access will be recruited into the study. Participants will be evaluated for their appropriateness to partake in the study and will be randomised into 1 of 3 arms of sternal closure post cardiac surgery. Participants will have their sternum closed according to the method they were randomised to and will be assessed for 6 weeks post-intervention to assess the safety and efficacy of their sternal closure method. Assessments will be conducted to assess the effectiveness of sternal closure and sternal union, participant safety and quality of life post-intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122714 0
Prof Jayme Bennetts
Address 122714 0
Cardiothroacic Surgical Unit, Flinders Private Hospital, Level 6, 1 Flinders Drive, Bedford Park, SA, 5042
Country 122714 0
Australia
Phone 122714 0
+61 8 8204 5618
Fax 122714 0
Email 122714 0
[email protected]
Contact person for public queries
Name 122715 0
Mr Rhys Hamson
Address 122715 0
Cardiac Surgery Quality and Outcomes, Flinders Private Hospital, Level 6, Room 6R303, 1 Flinders Drive, Bedford Park, SA, 5042
Country 122715 0
Australia
Phone 122715 0
+61 8 8204 5382
Fax 122715 0
Email 122715 0
[email protected]
Contact person for scientific queries
Name 122716 0
Mr Rhys Hamson
Address 122716 0
Cardiac Surgery Quality and Outcomes, Flinders Private Hospital, Level 6, Room 6R303, 1 Flinders Drive, Bedford Park, SA, 5042
Country 122716 0
Australia
Phone 122716 0
+61 8 8204 5382
Fax 122716 0
Email 122716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain participant confidentiality no participant data will be made available for the public or for any other purposes besides publication of study results.


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.