Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001286336
Ethics application status
Approved
Date submitted
28/08/2017
Date registered
6/09/2017
Date last updated
10/12/2020
Date data sharing statement initially provided
10/12/2020
Date results provided
10/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study comparing topical use of acetic acid at the exit site versus mupirocin to prevent exit site infections in peritoneal dialysis patients.
Scientific title
A feasibility study comparing topical use of acetic acid at the exit site versus mupirocin to prevent exit site infections in peritoneal dialysis patients.
Secondary ID [1] 292758 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACES Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal dialysis exit site infection
 304548 0
Condition category
Condition code
Renal and Urogenital 303870 303870 0 0
Kidney disease
Infection 303894 303894 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 (intervention): routine exit site cleaning + topical acetic acid
Group 2(control group - standard care): routine exit site cleaning + topical mupirocin

Routine exit site (ES) cleaning involves: Cleaning ES in the shower with a packet of sterile gauze with antibacterial soap and water, drying the ES after the shower with sterile gauze then sunning ES for 10 minutes where possible.
Topical mupirocin involves: application of small amount (approx.. 1/4 pea size) of Mupirocin ointment 2% with cotton tip, after cleaning and sunning of ES (as described above).
Topical acetic acid involves: application of sterile gauze soaked with 2% acetic acid (approximately 5ml) for 10 minutes contact time to the ES after cleaning and sunning of ES as above.

Exit site cares (including the intervention and control treatment) are performed daily in the morning and for the duration of the trial (12 months). Exit site cares are administered by the patient.
Intervention code [1] 298992 0
Treatment: Drugs
Intervention code [2] 299005 0
Prevention
Comparator / control treatment
The control group is standard exit site care + the application of topical mupirocin ointment 2% as described above.
Control group
Active

Outcomes
Primary outcome [1] 303224 0
Time to first exit site infection.

The exit site will be visually inspected by nursing staff at each clinical visit every 8-12 weeks. Patients will also have written instructions to inspect the exit site and alert nursing staff if there are signs of infection (as per normal existing clinical practice). Exit site infection will be defined by increased redness, tenderness and or discharge from the exit site with a positive culture on swab.
Timepoint [1] 303224 0
Within 12 months of intervention commencement.
Primary outcome [2] 303225 0
Rates of exit site infection expressed as episodes per patient year (a usual metric and performance indicator which is monitored and calculated routinely).
Timepoint [2] 303225 0
Rates of exit site infection are calculated per 12 patient months and the rate for the 12 months of intervention will be compared to the historical average and other metrics.
Primary outcome [3] 303236 0
Trial feasibility aspects:
1) Tolerability of acetic acid; qualitative and by recording and assessing adverse events - patient reported skin reactions & clinical examination of exit site for evidence of skin reactions - erythema, blistering etc.
2) Feasibility of application procedure, assessed by observation of participants application procedure at routine clinical follow up.
3) Assessment of follow up procedure - are routine clinical follow up timeframes sufficient to catch the clinical outcomes (and any problems with acetic acid application or reactions)? ie: if exit site infections occur at times between the scheduled follow up appointments are they being reported by patients - or presenting as emergency cases to hospital or being unreported? Is more regular follow up needed to re-educate about correct application procedure? This will be mostly a qualitative outcome.
Timepoint [3] 303236 0
Within 12 months of intervention commencement.
Secondary outcome [1] 338283 0
Time to exit site infection with Pseudomonas aeruginosa, which will be defined by clinical evidence of an exit site infection with a positive culture for Pseudomonas aeruginosa.
Timepoint [1] 338283 0
Within 12 months of intervention commencement.

Eligibility
Key inclusion criteria
All adult patients undergoing peritoneal dialysis under the catchement area of the Royal Brisbane and Women's Hospital.
No active peritonitits or exit site infection.
Ability to comply with exit site cares.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active infection.
Inability to comply with exit site cares.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a feasibility study and will aim to recruit all available patients in the service.
Exit site statistics, expressed as episodes per patient year will be separately calculated for each arm of the study. These will be compared with each other and also with previous year’s statistics for the whole unit. Time to exit site infection and time to Pseudomonas aeruginosa exit site infection will be compared using Kaplan–Meier estimators and the log-rank statistic, and Hazard rates for the outcomes will be compared using Cox models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/10/2017
Actual
13/02/2018
Date of last participant enrolment
Anticipated
13/02/2019
Actual
25/02/2019
Date of last data collection
Anticipated
2/10/2019
Actual
10/01/2020
Sample size
Target
70
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8902 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 17148 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 297393 0
Hospital
Name [1] 297393 0
Royal Brisbane and Women's Hospital
Country [1] 297393 0
Australia
Primary sponsor type
Individual
Name
Mrs Lesley Williams
Address
Department of Renal Medicine
Royal Brisbane and Women's Hospital
Herson 4029
Queensland
Australia
Country
Australia
Secondary sponsor category [1] 296378 0
Individual
Name [1] 296378 0
Mrs Nicola Williams
Address [1] 296378 0
Department of Renal Medicine
Royal Brisbane and Women's Hospital
Herston 4029
Queensland
Country [1] 296378 0
Australia
Secondary sponsor category [2] 296380 0
Individual
Name [2] 296380 0
Dr Martin Wolley
Address [2] 296380 0
Department of Renal Medicine
Royal Brisbane and Women's Hospital
Herston 4029
Queensland
Country [2] 296380 0
Australia
Secondary sponsor category [3] 296381 0
Individual
Name [3] 296381 0
Associate Professor Dwarakanathan Ranganathan
Address [3] 296381 0
Department of Renal Medicine
Royal Brisbane and Women's Hospital
Herston 4029
Queensland
Country [3] 296381 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298492 0
Royal Brisbane and Women's Hospital Human Ethics committee
Ethics committee address [1] 298492 0
Ethics committee country [1] 298492 0
Australia
Date submitted for ethics approval [1] 298492 0
28/08/2017
Approval date [1] 298492 0
30/11/2017
Ethics approval number [1] 298492 0
HREC/17/QRBW/490

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

Contacts
Principal investigator
Name 77262 0
Mrs Lesley Williams
Address 77262 0
Department of Renal Medicine
Royal Brisbane and Women's Hospital
Herston 4029
Queensland
Country 77262 0
Australia
Phone 77262 0
+61 7 3646 8111
Fax 77262 0
Email 77262 0
[email protected]
Contact person for public queries
Name 77263 0
Lesley Williams
Address 77263 0
Department of Renal Medicine
Royal Brisbane and Women's Hospital
Herston 4029
Queensland
Country 77263 0
Australia
Phone 77263 0
+61 7 3646 8111
Fax 77263 0
Email 77263 0
[email protected]
Contact person for scientific queries
Name 77264 0
Lesley Williams
Address 77264 0
Department of Renal Medicine
Royal Brisbane and Women's Hospital
Herston 4029
Queensland
Country 77264 0
Australia
Phone 77264 0
+61 7 3646 8111
Fax 77264 0
Email 77264 0
[email protected]

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


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.