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Trial registered on ANZCTR


Registration number
ACTRN12615000852550
Ethics application status
Approved
Date submitted
29/07/2015
Date registered
17/08/2015
Date last updated
14/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two different techniques to close the sternum following cardiac surgery
Scientific title
Comparison of sternal closure methods measuring pain and sternal stability following median sternotomy incision for cardiothoracic surgery
Secondary ID [1] 287173 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sternal fixation following sternotomy 295739 0
Condition category
Condition code
Surgery 296014 296014 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this research is to compare the outcomes in cardiac surgery patients who have sternal fixation using stainless steel wires (current practice at The Alfred) with patients who have sternal fixation using Zipfix cable ties (intervention).

Applying the Zipfix cable ties involves using 5 biocompatible cable ties looped around both halves of the sternum using a removable needle, then they are tightened to pull the sternal halves back together. The remaining length of the cable tie is then cut using a specialized cutting device.

Cardiac surgeons will perform the sternal closure on patients using the Zipfix system.
Intervention code [1] 292443 0
Treatment: Surgery
Intervention code [2] 292444 0
Rehabilitation
Comparator / control treatment
Cardiac surgery patients who have sternal fixation using stainless steel wires. This is standard care at The Alfred following cardiac surgery.
Control group
Active

Outcomes
Primary outcome [1] 295670 0
Primary outcome - postoperative pain
Level of postoperative pain will be assessed using the validated pain visual analogue scale.
Timepoint [1] 295670 0
Day 1, Day 3, at discharge and 4 weeks post median sternotomy
Secondary outcome [1] 316178 0
Sternal mobility in the postoperative period using the sternal instability scale.
Timepoint [1] 316178 0
Sternal mobility will be assessed at 4 weeks following median sternotomy using ultrasound.

Eligibility
Key inclusion criteria
The inclusion criteria are:
* undergoing an operation involving median sternotomy
* age greater than 18 years
* competence to provide informed consent
* ability to undertake the visual testing and complete questionnaires
* redo sternotomy will be included
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are:
* heart transplant and VAD patients

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)
The 120 patients will be recruited in chronological fashion. Only on the day of the operation will they be randomized to either group. using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program will be used to generate the randomization sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using a continuous definition of pain from the visual analog pain scale, a reduction of pain by 50% between groups is considered to be clinically significant. From a previous study involving massage in cardiac surgery patients with a mean pain score of 2.6 and delta value of 1.20, in order to detect a 50% reduction in pain with alpha level 0.05 and power 0.8 requires 54 patients. With a drop out rate of 10%, this would be 60 patients per group.

Therefore 60 patients per group would be adequately powered to detect a clinically significant difference in outcome measures. This will require enrollment of 120 patients in the study.

Visual analog pain scores will be analysed between groups comparing means between the two groups (t-tests).

Sternal instability will be analysed by a simple chi square analysis comparing proportions for the three categories of instability.

A multivariate analysis will be undertaken to account for confounding variables (ANCOVA).

The level of statistical significance will be set at a p-value <0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/09/2015
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4113 0
The Alfred - Prahran
Recruitment postcode(s) [1] 10038 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 291735 0
Self funded/Unfunded
Name [1] 291735 0
Country [1] 291735 0
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road
Melbourne 3004
Victoria
Country
Australia
Secondary sponsor category [1] 290409 0
None
Name [1] 290409 0
Address [1] 290409 0
Country [1] 290409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293250 0
The Alfred Human Research Ethics Committee (EC00315)
Ethics committee address [1] 293250 0
Ethics committee country [1] 293250 0
Australia
Date submitted for ethics approval [1] 293250 0
27/07/2015
Approval date [1] 293250 0
21/10/2015
Ethics approval number [1] 293250 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59090 0
A/Prof Silvana Marasco
Address 59090 0
The Alfred
Department of Cardiothoracic Surgery
55 Commercial Rd.
Melbourne, 3004.
Victoria
Country 59090 0
Australia
Phone 59090 0
+613 9076 3313
Fax 59090 0
Email 59090 0
[email protected]
Contact person for public queries
Name 59091 0
Silvana Marasco
Address 59091 0
The Alfred
Department of Cardiothoracic Surgery
55 Commercial Rd.
Melbourne, 3004.
Victoria
Country 59091 0
Australia
Phone 59091 0
+613 9076 3313
Fax 59091 0
Email 59091 0
[email protected]
Contact person for scientific queries
Name 59092 0
Silvana Marasco
Address 59092 0
The Alfred
Department of Cardiothoracic Surgery
55 Commercial Rd.
Melbourne, 3004.
Victoria
Country 59092 0
Australia
Phone 59092 0
+613 9076 3313
Fax 59092 0
Email 59092 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
SourceTitleYear of PublicationDOI
EmbaseProspective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy.2018https://dx.doi.org/10.1016/j.jtcvs.2018.04.025
N.B. These documents automatically identified may not have been verified by the study sponsor.