Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000496112
Ethics application status
Approved
Date submitted
20/03/2019
Date registered
27/03/2019
Date last updated
28/01/2022
Date data sharing statement initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy
Scientific title
Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy
Secondary ID [1] 297743 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SUNRRISE Australia
Linked study record
SUNRRISE ISRCTN17599457

This is the registration for the SUNRRISE Trial which is the UK 'parent' arm of SUNRRISE Australia

Health condition
Health condition(s) or problem(s) studied:
Surgical Site Infection 312074 0
Condition category
Condition code
Surgery 310637 310637 0 0
Other surgery
Infection 310688 310688 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention used in SUNRRISE is Single Use Negative Pressure Dressings (SUNPD). This is a foam pad which lies over the wound, covered with a semipermeable adhesive plastic membrane. A sealed tube connects the foam to an external pump, which creates a negative pressure gradient over the wound. This closed negative-pressure environment removes blood and serous fluid exuding from the wound. The SUNPD is put in place, in theatre, after wound closure and is left in situ for 7 days.

The intervention and control dressings are put in place by the surgeon or the surgical registrar for each case. Observation charts are kept up to date on the ward.
Intervention code [1] 313979 0
Treatment: Devices
Intervention code [2] 314021 0
Prevention
Comparator / control treatment
The Comparator / control group in the SUNRRISE trial is a conventional wound dressing of the consulting surgeons choice as long as this is not a Single Use Negative Pressure Dressing or similar device. Conventional wound dressings for emergency laparotomy sites are typically an adhesive backed semipermeable plastic membrane with or without an absorbent pad.
Control group
Active

Outcomes
Primary outcome [1] 319483 0
Surgical site infection within 30 days post-operation – as defined by the internationally accredited Centers for Disease Control (CDC) criteria.
Timepoint [1] 319483 0
Within 30 days post- operation
Secondary outcome [1] 368364 0
Length of hospital stay after surgery, determined by date of discharge within 30 days post-operation from medical record.
Timepoint [1] 368364 0
Discharge
Secondary outcome [2] 368365 0
Wound complications as graded by the Clavien-Dindo scale
Timepoint [2] 368365 0
Within 30 days post-operation
Secondary outcome [3] 368366 0
Hospital re-admission rate for wound related complication within 30 days, determined by record of readmission from medical record.
Timepoint [3] 368366 0
Within 30 days post-operation
Secondary outcome [4] 368367 0
Health-related Quality of Life using Short Form-12 Health Survey (SF-12) and EuroQol-5 Dimension-5 Level (EQ-5D-5L)

This is a composite outcome
Timepoint [4] 368367 0
EQ-5D-5L - pre op and post op days 7, 14, 21 and 30
SF-12 - pre op and post op days 7and 30
Secondary outcome [5] 368368 0
Serious adverse events.

As the dressings being tested in this trial are available and often used within the Australian healthcare system, there are no Serious Adverse Events that would be anticipated as a unique consequence of participation in the trial. We would, however, expect the following events to always be reported as SAEs:
o Entero-cutaneous fistula
o Fascial dehiscence
o Death

Determined by clinical and/or imaging diagnosis as advised by treating clinician or as stated in medical record.
Timepoint [5] 368368 0
All within 30 days post-operation
Secondary outcome [6] 368369 0
Cost effectiveness
The health economics element of the trial will encompass two phases.
The first will involve a review of the current economic evidence regarding topical negative pressure devices. This will encompass both the comparative costs and benefits associated with the use of negative pressure dressings. It is expected that the published evidence will not be able to answer the question of cost effectiveness in the specific cohort of patients that SUNRRISE investigates.

The second phase will involve development of a novel economic model. This will estimate the comparative long-term cost effectiveness of
the dressings using clinical and economic data generated by the trial. It is envisaged that the model will consist of two parts.

1. The first (short-run) sub-model will consider the costs of the different pressure dressings incorporating any associated health service costs related directly to their use. The short- run model would also incorporate estimates of wound infection rates and hospital lengths of stay and associated costs gained directly from the clinical trial.

2. The second (long-run) element of the model would seek to estimate the longer-term health effects arising from the comparative costs and effectiveness of the use of the negative pressure dressings. The structure of the longer-term model would extrapolate the clinical results obtained in the trial to evaluate the long-term clinical, quality of life and cost benefits arising to patients and the healthcare system associated with the use of negative pressure dressings. Due to the long-term nature, the results will be reported after and separately to the other trial results.
Timepoint [6] 368369 0
Total cost within 30 days post-operation
Secondary outcome [7] 368370 0
Patient acceptability of use of their dressing via an acceptability score using a Likert scale of 1-10 at day 7.
Timepoint [7] 368370 0
Day 7 post operation

Eligibility
Key inclusion criteria
-Patients undergoing emergency (non-elective) laparotomy
-Procedures with a planned incision of at least 5cm
-Operations where the skin is closed primarily
-Patients aged at least 18 years
-Patient able to provide written informed consent
-Patients willing and able to undergo follow-up at 30 days post-op
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Abdominal surgery within the preceding three months from the date of randomization
-Expected return to theatre for reopening of the laparotomy wound within 30 days
-Patients unable to provide informed consent and participate in English

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 are randomised between the intervention group (SUNPD) and control group (surgeon’s preference of dressing). The randomisation will take place in theatre using an online or telephone-based randomisation system following commencement of closure of skin.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will take place in theatre using an online or telephone-based randomisation system following commencement of closure of skin.

Participants will be randomised at the level of the individual in a 1:1 ratio. A minimisation algorithm will be used within the randomisation system to ensure balance in the treatment allocation over the following variables:

-Degree of contamination (clean, clean contaminated, contaminated, dirty)
-Whether or not a stoma is present (yes, no)
-If a stoma is present, whether it was pre-existing or formed during the operation will also be ascertained. However, this distinction will not be factored in to the minimisation process.
-Recruiting site
A ‘random element’ will be included in the minimisation algorithm, so that each participant has a probability (unspecified here), of being randomised to the opposite treatment that they would have otherwise received.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The justification for the sample size is based on data from the ROSSINI trial, which reported an SSI rate of 25% in the control group. To detect a relative reduction of 40% in SSI rates (i.e. from 25% to 15%, so 10% absolute difference) between groups using the standard method of difference between proportions (2-sided) with 80% power and a type I error rate of 5% (i.e. a=0.05), requires 336 participants per group to be randomised, so 672 in total. Assuming and adjusting for a 20% attrition/loss to follow-up rate (based on the death rate in this population being approximately 10% at 30 days; further drop out 10%), 840 participants (420 per group) will need to be recruited. Stata 15 software was used to compute the sample size using the two-sample proportions test.
840 Participants will be randomised between the UK and Australia. The randomisation service is common to the whole trial, and the appropriate measures are in place to ensure that over-recruitment cannot occur.
The 40% reduction correlates with the relative reduction being assessed in other large HTA funded SUNPD trials, such as WHIST

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/11/2019
Actual
23/01/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
29/01/2021
Date of last data collection
Anticipated
28/02/2021
Actual
20/07/2021
Sample size
Target
840
Accrual to date
Final
304
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 13429 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 13430 0
Gosford Hospital - Gosford
Recruitment hospital [3] 13432 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 13433 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 13434 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 13435 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 13436 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [8] 15177 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [9] 21593 0
Concord Repatriation Hospital - Concord
Recruitment hospital [10] 21594 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [11] 21595 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 26034 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 26036 0
2250 - Gosford
Recruitment postcode(s) [3] 26038 0
4575 - Birtinya
Recruitment postcode(s) [4] 26039 0
5042 - Bedford Park
Recruitment postcode(s) [5] 26040 0
5000 - Adelaide
Recruitment postcode(s) [6] 26041 0
6150 - Murdoch
Recruitment postcode(s) [7] 26042 0
3084 - Heidelberg
Recruitment postcode(s) [8] 28480 0
3011 - Footscray
Recruitment postcode(s) [9] 28481 0
6008 - Subiaco
Recruitment postcode(s) [10] 36513 0
2139 - Concord
Recruitment postcode(s) [11] 36514 0
6009 - Nedlands
Recruitment postcode(s) [12] 36515 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 302268 0
Government body
Name [1] 302268 0
MRFF International Clinical Trial Collaborations (ICTC) Program
Country [1] 302268 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
The University of Newcastle
University Dr, Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 302192 0
None
Name [1] 302192 0
Address [1] 302192 0
Country [1] 302192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302944 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 302944 0
Ethics committee country [1] 302944 0
Australia
Date submitted for ethics approval [1] 302944 0
31/01/2019
Approval date [1] 302944 0
01/03/2019
Ethics approval number [1] 302944 0
2019/ETH00189

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

Contacts
Principal investigator
Name 91930 0
Dr Peter Pockney
Address 91930 0
John Hunter Hospital
Surgical Services
Locked Bag No. 1, Hunter Region Mail Centre,
NSW 2310
Australia
Country 91930 0
Australia
Phone 91930 0
+6140420889
Fax 91930 0
Email 91930 0
peter.pockney@newcastle.edu.au
Contact person for public queries
Name 91931 0
Kristy Atherton
Address 91931 0
Hunter Medical Research Institute, Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country 91931 0
Australia
Phone 91931 0
+6140420889
Fax 91931 0
Email 91931 0
sunrriseaus@newcastle.edu.au
Contact person for scientific queries
Name 91932 0
Peter Pockney
Address 91932 0
John Hunter Hospital
Surgical Services
Locked Bag No. 1, Hunter Region Mail Centre,
NSW 2310
Australia
Country 91932 0
Australia
Phone 91932 0
+6140420889
Fax 91932 0
Email 91932 0
sunrriseaus@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5729Study protocolNAhttps://hmri.org.au/sunrrise-trialsunrriseaus@newcastle.edu.au NA



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.