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Trial registered on ANZCTR


Registration number
ACTRN12615000973516
Ethics application status
Approved
Date submitted
30/08/2015
Date registered
17/09/2015
Date last updated
17/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing sternal wires with sternal cabling for prevention of deep sternal wound infection in patients undergoing cardiac surgery
Scientific title
A Randomised Controlled Trial of Sternal Closure with Sternal Wires or Sternal Cables for prevention of Deep Sternal Wound Infection in patients undergoing cardiac surgery
Secondary ID [1] 287376 0
Nil
Universal Trial Number (UTN)
Trial acronym
PiCT – Pioneer Cabling Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Sternal Wound Infection 296062 0
Condition category
Condition code
Surgery 296326 296326 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Pioneer Sternal Cabling system is used to approximate the cut edges of the sternum after median sternotomy. It uses braided titanium cables in figure-eight formation, tightened with a specifically-designed tool to tighten the cables and achieve equal distribution of forces and prevent over-tightening.
Intervention code [1] 292721 0
Treatment: Surgery
Intervention code [2] 292778 0
Prevention
Comparator / control treatment
Stainless steel wires have been used for 50 years in cardiac surgery. They are simply placed in simple loops, figure-eight formation or a variety of complex formations then tightened manualy to approximate the sternal plates after median sternotomy
Control group
Active

Outcomes
Primary outcome [1] 295980 0
Rate of Deep Sternal Wound Infection at 30 days post-op. As defined by ANZSCTS (Australian and New Zealand Society of Cardiothoracic Surgeons): DSWI is defined by positive cultures taken from the patient’s sternal tissue or mediastinal biopsy at the time of reoperation.
Timepoint [1] 295980 0
30 days post-op
Secondary outcome [1] 317088 0
Requirement for sternal rewiring at 30 days post-op, assessed prospectively as all rewiring procedures were be performed in our unit
Furthermore, at routine outpatient follow-up any patients that required rewiring at another institution were recorded (there were none).


Timepoint [1] 317088 0
30 days post-op
Secondary outcome [2] 317316 0
Pain scores at days 3 and 5 post-op
Pain scores were assessed using the Modified Brief Pain Inventory - Short Form (MBPI-SF)
Timepoint [2] 317316 0
Days 3 and 5 post-op
Secondary outcome [3] 317317 0
Analgaesia requirements at day 3, day 5 and on discharge
Analgaesia requirement was determined by a specific step-wise analgaesia protocol

Prospectively recorded on ward round as team reviewed the medication chart the analgaesia requirements for the previous 24 hours were recorded
Timepoint [3] 317317 0
Day 3 post-op, Day 5 post-op and on day of hospital discharge

Eligibility
Key inclusion criteria
Our inclusion criteria were any patient of 18 years of age or older, presenting for first time elective, urgent or emergent cardiac surgery via full sternotomy and being able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Redo Sternotomy
Salvage surgery – CPR en route to theatre
Cardiac transplant
Left ventricular assist device insertion
Pregnant women
Patients with cognitive impairment
Intravenous drug users
Patients on opiate analgaesia pre-op

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were referred and worked up for cardiac surgery as per our institution’s usual practice. Consent for participation in the trial was obtained at the time consent for the planned operation was obtained. The patients were randomised, using block randomization, by a blinded research coordinator on the morning of surgery and the allocation was revealed to the surgical team just prior to commencement of sternal closure via a sealed envelope delivered to the operating theatre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analyses were performed using SPSS version 23. Means were compared using independent sample t tests. Proportions were compared using Chi squared tests (or Fisher’s exact test if observed counts <5). P values of less than 0.05 were taken as statistically significant.
An a priori subgroup of patients at high risk for DSWI was selected for analysis. The patients in this subgroup were diabetic patients with a BMI >30. They were analysed separately to assess the outcomes of wires compared to cables in this high-risk population.

Our study was designed for 80% power to demonstrate a reduction in DSWI from a baseline rate of 3% to 1% with an alpha value of 0.05. Our goal was to recruit 800 patients but difficulty with recruitment and the relocation of our surgical unit to a new institution at the beginning of 2015 limited our ability to achieve our target. We enrolled 273 patients by the end of our study period. As we realised the rate of recruitment was not going to enable us to enroll 800 patients in our time frame, we revised our target to 300.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4277 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 10225 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 291938 0
Hospital
Name [1] 291938 0
Royal Perth Hospital
Address [1] 291938 0
197 Wellington St, Perth, Western Australia, WA 6000
Country [1] 291938 0
Australia
Primary sponsor type
Individual
Name
Mr Chris Merry
Address
Dept of Cardiothoracic Surgery
Fiona Stanley Hospital
Murdoch Drive
WA 6150
Australia
Country
Australia
Secondary sponsor category [1] 290608 0
Individual
Name [1] 290608 0
Dr Ben Dunne
Address [1] 290608 0
Dept of Cardiothoracic Surgery
Fiona Stanley Hospital
Murdoch Drive
WA 6150
Australia
Country [1] 290608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293439 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 293439 0
Royal Perth Hospital
Wellington St
Perth
WA 6000
Ethics committee country [1] 293439 0
Australia
Date submitted for ethics approval [1] 293439 0
16/01/2013
Approval date [1] 293439 0
16/04/2013
Ethics approval number [1] 293439 0
13-020

Summary
Brief summary
Background
Deep sternal wound infection is a devastating complication of cardiac surgery. In the current era of increasing patient co-morbidity, newer techniques must be evaluated in attempts to reduce the rates of deep sternal wound infection.
Methods
A randomised controlled trial comparing sternal closure with traditional sternal wires in figure-8 formation with the Pioneer cabling system [Registered Trademark] from Medigroup after adult cardiac surgery was performed.
Results
273 patients were enrolled with 137 and 135 patients randomised to sternal wires and cables group, respectively. Baseline characteristics between the two groups were well balanced. Deep sternal wound infection occurred in 0.7% of patients in the wires group and 3.7% of patients in the cables group (absolute risk difference = -3.0%, 95% confidence interval: -7.7% to 0.9%; p=0.12). Patients in the cables group were extubated slightly earlier than the patients in the sternal wires group postoperatively (9.7 vs. 12.8 hours; p=0.03). There was, however, no significant difference in hospital and follow-up pain scores or analgaesia requirements.
Conclusions
The Pioneer sternal cabling system appears to facilitate early extubation after adult cardiac surgery, but it does not reduce the rate of deep sternal infection.
Trial website
No publications/citations to date
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59938 0
Mr Chris Merry
Address 59938 0
Dept of Cardiothoracic Surgery
Fiona Stanley Hospital
Murdoch Drive
WA 6150
Australia

Country 59938 0
Australia
Phone 59938 0
+61 8 6152 2222
Fax 59938 0
Email 59938 0
chris.merry@health.wa.gov.au
Contact person for public queries
Name 59939 0
Dr Ben Dunne
Address 59939 0
Dept of Cardiothoracic Surgery
Fiona Stanley Hospital
Murdoch Drive
WA 6150
Australia
Country 59939 0
Australia
Phone 59939 0
+61 8 6152 2222
Fax 59939 0
Email 59939 0
bendunne@icloud.com
Contact person for scientific queries
Name 59940 0
Dr Ben Dunne
Address 59940 0
Dept of Cardiothoracic Surgery
Fiona Stanley Hospital
Murdoch Drive
WA 6150
Australia
Country 59940 0
Australia
Phone 59940 0
+61 8 6152 2222
Fax 59940 0
Email 59940 0
bendunne@icloud.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary