ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Total Shoulder Arthroplasty

Rotator Cuff Injury

Shoulder Osteoarthritis

Condition category

Condition code

Surgery

Other surgery

Skin

Other skin conditions

Infection

Other infectious diseases

Musculoskeletal

Osteoarthritis

Injuries and Accidents

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]

Treatment: Drugs

Intervention code [2]

Treatment: Other

Intervention code [3]

Prevention

Comparator / control treatment

pHisohex (1% triclosan, sodium benzoate 5mg/mL benzyl alcohol 5mg/mL) wash

Control group

Active

Outcomes

Primary outcome [1]

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]

Pre-op and intraoperatively swabs will be taken to determine positive P. acnes culture rate.

Secondary outcome [1]

To determine the rate of P. Acnes contamination in primary total shoulder arthroplasty.

Timepoint [1]

Following growth of cultures taken intra-operatively - assessed by swabs of shoulder skin area and deep swabs

Secondary outcome [2]

To determine the level of compliance relating to application of 3 different shoulder preparations prior to arthroplasty.

Timepoint [2]

Compliance with the various skin preparations will be completed at the 2 week follow-up via survey.

Secondary outcome [3]

To determine the rate of P. Acnes innoculation in primary total shoulder arthroplasty.

Timepoint [3]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Hospital Pimlico - Pimlico

Recruitment postcode(s) [1]

4810 - Pimlico

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Orthopaedic Research Institute Queensland

Address [1]

7 Turner Street, Pimlico, 4812. Queensland

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Research Governance

Ethics committee address [1]

Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2017

Approval date [1]

14/11/2017

Ethics approval number [1]

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]

/AnzctrAttachments/373748-ORIQL Study Protocol TSA - Hinton (1) - with references.docx (Protocol)

Attachments [2]

/AnzctrAttachments/373748-Participant Information Sheet (1.1).docx (Participant information/consent)

Contacts

Principal investigator

Name

Dr Matthew Wilkinson

Address

7 Turner St, Pimlico, QLD 4812, Australia.
Orthopedic Research Institute of Queensland

Country

Australia

Phone

+61 7 4755 0564

Fax

research_coordinator@oriql.com.au

Contact person for public queries

Name

Andrea Grant

Address

7 Turner St, Pimlico, QLD 4812, Australia.
Orthopedic Research Institute of Queensland

Country

Australia

Phone

+61 7 4755 0564

Fax

research_coordinator@oriql.com.au

Contact person for scientific queries

Name

Andrea Grant

Address

7 Turner St, Pimlico, QLD 4812, Australia.
Orthopedic Research Institute of Queensland

Country

Australia

Phone

+61 7 4755 0564

Fax

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.

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