Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000376448p
Ethics application status
Not yet submitted
Date submitted
4/04/2025
Date registered
29/04/2025
Date last updated
29/04/2025
Date data sharing statement initially provided
29/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of XPERIENCE advanced surgical irrigation on Cutibacterium Acnes contamination in shoulder arthroplasty
Scientific title
Effect of XPERIENCE advanced surgical irrigation on Cutibacterium Acnes contamination in shoulder arthroplasty
Secondary ID [1] 314132 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Osteoarthritis 336940 0
Condition category
Condition code
Infection 333411 333411 0 0
Other infectious diseases
Musculoskeletal 333412 333412 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study seeks to assess if the XPERIENCE® Advanced Surgical Irrigation (XASI) wash can reduce the incidence of Cutibacterium acnes (C. Acnes) pathogen contamination in shoulder arthroplasty surgery. XASI is an intra-operative surgical irrigant employed to cleanse and remove debris including micro-organisms, from the surgical wound space. It was designed as a no-rinse intraoperative surgical irrigation solution. It consists of citric acid, sodium citrate, and sodium lauryl sulfate in water. Citric acid and sodium citrate serve as pH buffers and aid in metal ion chelation, while sodium lauryl sulfate acts as a surfactant, assisting in debris removal including micro-organisms.

XASI will be placed into the wound (following skin incision and once the wound is opened to expose the shoulder joint) as a wash and allowed to remain in the surgical field until the shoulder arthroplasty procedure has been completed. Following the completion of the surgical procedure, the wound will then be washed appropriately with normal saline irrigation prior to wound closure. For each procedure, a 500ml container is emptied into the surgical wound site in all cases.

Recruited patients will be randomized into two groups: 1) specimen swabs taken before receiving 500ml of XASI (Group 1, which is the control group for the purpose of the study), or 2) receiving 500ml of XASI before specimen swabs are taken (Group 2, which is the intervention group for the purpose of the study). All participants will therefore undergo the XPERIENCE® wash. Swabs will be taken from six different sites from around the skin incision and surgeon’s instruments, and is expected to add an extra 2-3 minutes to the operating time.
Intervention code [1] 330720 0
Treatment: Drugs
Comparator / control treatment
While there is no comparator as such, Group 1 has been allocated as the control group for the purpose of the study (specimen swabs taken before receiving 500ml of the XPERIENCE® wash). All participants will undergo the XPERIENCE® wash. However, swabs will be taken from patients randomized to two groups which will be either before (Group 1, which is the control group for the purpose of the study) or after (Group 2, which is the intervention group for the purpose of the study) having the XPERIENCE® wash applied.
Control group
Active

Outcomes
Primary outcome [1] 340986 0
Presence of Cutibacterium Acnes contamination. Six swab sites will be assessed, with a composite score reviewed from these six sites. If three (or more) of the six swabs test positive for C. acnes, a positive infection will be recorded for this primary outcome. Swabs will be taken from the following six sites: one at the edges of the skin incision (at the exposed subdermal layer of the incision), four from the surgeon’s instruments (outside scalpel blade, inside scalpel blade, forceps and the tip of the surgeon’s glove), and one at the edges of the skin incision.
Timepoint [1] 340986 0
Samples will be assessed for contamination at 24 and 48 hours post-intervention application for aerobic plates and at 48 hours, 5, 10, and 14 days post-intervention application for anaerobic plates. The primary timepoint is 14 days post-intervention application.
Secondary outcome [1] 445683 0
There are no secondary outcomes
Timepoint [1] 445683 0
There are no secondary outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria
- Age 40-80 years.
- Clinical and radiographic diagnosis of end-stage shoulder arthritis, indicated for primary shoulder arthroplasty.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
- Use of antibiotics within 2 weeks prior to the surgical procedure.
- Cortisone injection into the shoulder within 3 months prior to the procedure.
- Not willing to sign the Patient Consent Form relevant to the study.

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)
Randomization will be undertaken via concealed envelopes provided at the time of surgery (Group 1 = microscopy, culture and sensitivity (MC&S) swabs taken before receiving 500ml of XASI, Group 2 = receiving 500ml of XASI before microscopy, culture and sensitivity swabs are taken).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be undertaken via a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using SPSS software (SPSS, Version 29.0, SPSS Inc., USA), with statistical significance determined at p<0.05. Statistical analysis will investigate differences in the proportion of patients with C. acnes incidence, across each of the swab sites, using chi-square tests (proportions).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27698 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 43888 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318641 0
Charities/Societies/Foundations
Name [1] 318641 0
Hollywood Private Hospital Research Foundation
Country [1] 318641 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Perth Orthopaedic and Sports Medicine Research Foundation
Address
Country
Australia
Secondary sponsor category [1] 321060 0
None
Name [1] 321060 0
Address [1] 321060 0
Country [1] 321060 0
Other collaborator category [1] 283465 0
University
Name [1] 283465 0
University of Western Australia
Address [1] 283465 0
Country [1] 283465 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317251 0
Ramsay Health Care WA / SA Human Research Ethics Committee
Ethics committee address [1] 317251 0
Ethics committee country [1] 317251 0
Australia
Date submitted for ethics approval [1] 317251 0
01/06/2025
Approval date [1] 317251 0
Ethics approval number [1] 317251 0

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

Contacts
Principal investigator
Name 140466 0
Mr Travis Falconer
Address 140466 0
Perth Orthopaedic and Sports Medicine Centre, Level 1/1 Havelock St, West Perth WA 6005
Country 140466 0
Australia
Phone 140466 0
+61 8 9212 4200
Fax 140466 0
Email 140466 0
[email protected]
Contact person for public queries
Name 140467 0
Travis Falconer
Address 140467 0
Perth Orthopaedic and Sports Medicine Centre, Level 1/1 Havelock St, West Perth WA 6005
Country 140467 0
Australia
Phone 140467 0
+61 8 9212 4200
Fax 140467 0
Email 140467 0
[email protected]
Contact person for scientific queries
Name 140468 0
Dr Jay Ebert
Address 140468 0
Perth Orthopaedic and Sports Medicine Research Institute, Level 1/1 Havelock St, West Perth WA 6005
Country 140468 0
Australia
Phone 140468 0
+61 8 9212 4200
Fax 140468 0
Email 140468 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: While pooled de-identified data will be published (and/or presented) in a scientific forum, there is no intention to share individual participant data. the HREC approval being sought is exclusively for the study proposed, and not to be used for other purposes.



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.