Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000261213
Ethics application status
Approved
Date submitted
1/11/2017
Date registered
20/02/2018
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of topical preparations in reducing the incidence of P. Acnes in total shoulder arthroplasty
Scientific title
The efficacy of topical preparations in reducing the incidence of P. Acnes in total shoulder arthroplasty
Secondary ID [1] 293437 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Shoulder Arthroplasty 304930 0
Rotator Cuff Injury 305608 0
Shoulder Osteoarthritis 305609 0
Condition category
Condition code
Surgery 304258 304258 0 0
Other surgery
Skin 304573 304573 0 0
Other skin conditions
Infection 304829 304829 0 0
Other infectious diseases
Musculoskeletal 304830 304830 0 0
Osteoarthritis
Injuries and Accidents 304831 304831 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to investigate the use of BPO and BPO/C as a topical skin preparation and to determine the effects it has in reducing positive superficial and deep cultures in patients undergoing TSA.

3 Groups.
1. Benzoyl Peroxide 5% Gel
2. Phisohex wash (1% triclosan, sodium benzoate 5mg/ml, benzyl alcohol 5mg/ml)
3. Benzoyl Peroxide 5% Gel with Clindamycin Gel 1%

All these are topical skin applications.
Patients are to apply morning and night starting two days prior to surgery and applying their last application the morning of surgery. (Total of 5 applications) The Gel/wash is to be applied liberally to the entire shoulder area as instructed by study investigators and explained with pictures in the patient information consent form document.
Intervention code [1] 299254 0
Treatment: Drugs
Intervention code [2] 299679 0
Treatment: Other
Intervention code [3] 299680 0
Prevention
Comparator / control treatment
pHisohex (1% triclosan, sodium benzoate 5mg/mL benzyl alcohol 5mg/mL) wash
Control group
Active

Outcomes
Primary outcome [1] 303540 0
This is a composite primary outcome. To quantify the effects of benzyl peroxide and benzyl peroxide with clindamycin skin prep preoperatively on the ability to reduce superficial colonization and deep tissue inoculation of Propionibacterium. acnes (P. acnes).
Timepoint [1] 303540 0
Pre-op and intraoperatively swabs will be taken to determine positive P. acnes culture rate.
Secondary outcome [1] 339242 0
To determine the rate of P. Acnes contamination in primary total shoulder arthroplasty.
Timepoint [1] 339242 0
Following growth of cultures taken intra-operatively - assessed by swabs of shoulder skin area and deep swabs
Secondary outcome [2] 340178 0
To determine the level of compliance relating to application of 3 different shoulder preparations prior to arthroplasty.
Timepoint [2] 340178 0
Compliance with the various skin preparations will be completed at the 2 week follow-up via survey.
Secondary outcome [3] 341006 0
To determine the rate of P. Acnes innoculation in primary total shoulder arthroplasty.
Timepoint [3] 341006 0
Following growth of cultures taken intra-operatively - assessed by swabs of shoulder skin area and deep swabs

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Male or Female
2. Age 30-90
a. This age range depicts the typical population that undergo total shoulder arthroplasty. Participants less than 30 years are not amenable to a total shoulder arthroplasty. Patients older than 90 years often have much higher co-morbidity and have an increased risk of complications and thus do not typically have total shoulder arthroplasty.
4. Patients who require a primary TSA for treatment of OA or rotator cuff injuries
Minimum age
30 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
Patients with active infection
Patients with BMI >40, (may impact on study)
Patients who are pregnant or planning on becoming pregnant during the course of the study
Patients unable to provide informed consent
Patients who have undergone previous arthroplasty, have had previous infection, previous surgical procedures or injection into the shoulder within the previous 6 months prior to surgery.
Patients with documented allergy to any of the skin preparation solutions
Patients with English as second language unless understanding English proficiently or a translator service is available

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer Randomization Number generator program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using SPSS version 22

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2018
Actual
16/07/2018
Date of last participant enrolment
Anticipated
20/11/2019
Actual
Date of last data collection
Anticipated
30/12/2019
Actual
Sample size
Target
105
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9146 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 17649 0
4810 - Pimlico

Funding & Sponsors
Funding source category [1] 297646 0
Other Collaborative groups
Name [1] 297646 0
Orthopaedic Research Institute Queensland
Country [1] 297646 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Orthopaedic Research Institute Queensland
Address
7 Turner Street, Pimlico, 4812. Queensland
Country
Australia
Secondary sponsor category [1] 296667 0
None
Name [1] 296667 0
Address [1] 296667 0
Country [1] 296667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298732 0
Mater Research Governance
Ethics committee address [1] 298732 0
Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Ethics committee country [1] 298732 0
Australia
Date submitted for ethics approval [1] 298732 0
02/11/2017
Approval date [1] 298732 0
14/11/2017
Ethics approval number [1] 298732 0
Mhs20171114-02

Summary
Brief summary
Elective total shoulder arthroplasty (TSA) is a common and effective orthopaedic procedure for the treatment of osteoarthritis and rotator cuff injuries. Infection remains a common reason for surgical revision. A common bacteria causing these infection is Propionibacterium Acnes.
The current method to reduce post op infections is to use skin preparations prior to surgery. This standard surgical prophylaxis does not seem to decrease the bacterial load. This may be a potential source of infection for susceptible patients having procedures with surgical implants.
Benzyl Peroxide (BPO) and Benzyl Peroxide/Clindamycin (BPO/C) topical skin preparations have been shown to reduce the superficial skin colonization of P. acnes. This study aims to investigate the use of BPO and BPO/C as a topical skin preparation and to determine the effects it has in reducing positive cultures in patients undergoing TSA.

Study Outcomes
• Contamination and inoculation with P. Acnes will be determined via microbiological analysis. Positive cultures will be noted and compared statistically between groups. From this data efficacy between preparations can be determined.
• Compliance with the various skin preparations will be completed at the 2 week follow-up via survey.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2162 2162 0 0
/AnzctrAttachments/373748-ORIQL Study Protocol TSA - Hinton (1) - with references.docx (Protocol)
Attachments [2] 2163 2163 0 0
/AnzctrAttachments/373748-Participant Information Sheet (1.1).docx (Participant information/consent)

Contacts
Principal investigator
Name 78050 0
Dr Matthew Wilkinson
Address 78050 0
7 Turner St, Pimlico, QLD 4812, Australia.
Orthopedic Research Institute of Queensland
Country 78050 0
Australia
Phone 78050 0
+61 7 4755 0564
Fax 78050 0
Email 78050 0
research_coordinator@oriql.com.au
Contact person for public queries
Name 78051 0
Mrs Andrea Grant
Address 78051 0
7 Turner St, Pimlico, QLD 4812, Australia.
Orthopedic Research Institute of Queensland
Country 78051 0
Australia
Phone 78051 0
+61 7 4755 0564
Fax 78051 0
Email 78051 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 78052 0
Mrs Andrea Grant
Address 78052 0
7 Turner St, Pimlico, QLD 4812, Australia.
Orthopedic Research Institute of Queensland
Country 78052 0
Australia
Phone 78052 0
+61 7 4755 0564
Fax 78052 0
Email 78052 0
research_coordinator@oriql.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
At this current point in time I would need to discuss with the investigative team if sharing this data would be appropriate.


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.