Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001295538p
Ethics application status
Submitted, not yet approved
Date submitted
25/11/2015
Date registered
27/11/2015
Date last updated
31/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study- Comparing two surgical preparations Chlorhexidine 2% and Chlorhexidine 2% with Benzyol peroxide 5% for reduction of Propionobacterium acnes in the shoulder region.
Scientific title
Pilot Study- Comparing two surgical preparations Chlorhexidine 2% and Chlorhexidine 2% with Benzyol peroxide 5% for reduction of Propionobacterium acnes in the shoulder region of healthy volunteers.
.
Secondary ID [1] 287967 0
Nil known
Universal Trial Number (UTN)
U1111-1176-4935
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative shoulder infection 296884 0
Condition category
Condition code
Skin 297072 297072 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who choose to enrol in the study will be scheduled a time to come into hospital to a theatre room. The participant is required to complete a health questionnaire and is allocated a research number. This number will be used to label and track swabs without identifying the participant.

The participant is then prepared in the same manner as for shoulder joint surgery.
Each shoulder region of the participant is assigned a different preparation/treatment through a randomisation process. The intervention is the Bezoyl peroxide 5% followed by Chlorhexidine 2%. The comparison is two applications of Chlorhexidine 2%.

One swab will be taken from each anterior deltoid and central axilla. This is done by drawing a line from the corocoid process to the axillary fold. The anterior deltoid swab is taken from the midpoint of this line and the axillary swab from the axillary end of the line. A 5x5 cm area of skin at each site for sampling (two per shoulder) is marked out.

The pre skin prep swab is taken using a standard bacterial swab with Amies transport medium without charcoal. Care is taken to avoid anything touching the tip or lower shaft of the swab, the swab is moistened in the transport medium and then swabbed over the marked area of skin. This will be done by rolling the swab horizontally in a zig-zag motion from the top left hand corner of the marked area downwards and then covering the same area again by going in the reverse direction. Downward pressure should be applied to the swab whilst rolling. The swab is then placed in the transport medium and labelled with the appropriate blinded study number.

The shoulder region in the interventional group will then be prepped with Bezoyl peroxide wash 5%. This is left to dry for two minutes, then Chlorhexidine 2% is applied over top and left to dry for a further two minutes. The comparison group will be prepared with two applications of Chlorhexidine 2% two minutes apart.
Once the preparation has dried in both groups repeat swabs are to be taken from the above outlined anterior deltoid and central axillar areas in the same manner as described above.

The swabs are then sent to the laboratory for processing as soon as possible.
All initial swab processing is performed in the class II biosafety cabinet taking care not to touch the swab tip or shaft. The swab is plated onto a Columbia Heavy Fill Blood Agar plate in the standard semi-quantitative fashion, using the swab to create a primary inoculum over the lower ¼ of the plate ensuring that all sides of the swab have been inoculated. The primary inoculum is then streaked out using a disposable plastic loop in the standard fashion using 3 streak lines. The loop should be turned over between each streak using a fresh side of the loop. The plate is labelled with the appropriate blinded study number and the date of processing. Plates are then placed into an airtight container with an anaerobic gas pack along with an anaerobic indicator strip. The container is then to be placed into an incubator at 35-37C.

Plates will be read at 7 days, where the anaerobic indicator strip checked and result recorded. Suspect colonies will be confirmed by MALDI-TOF MS as P. acnes. P. acnes colonies are quantified using the standard scanty, light, moderate, heavy scoring system. If no growth at 7 days, plates are re-incubated in same conditions for a further 7 days and then read in the same way.
Intervention code [1] 293328 0
Prevention
Comparator / control treatment
Each shoulder region of the participant is assigned a different preparation/treatment through a randomisation process. The intervention is the Bezoyl peroxide 5% followed by Chlorhexidine 2%. The comparison is two applications of Chlorhexidine 2%.
Control group
Active

Outcomes
Primary outcome [1] 296706 0
Proportion of participants positive for P. acnes growth in shoulder region after 14 days incubation from a skin swab.
Timepoint [1] 296706 0
14 days
Secondary outcome [1] 319144 0
Colony count of P.acnes on agar plate that has been cultured from a skin swab
Timepoint [1] 319144 0
14 days

Eligibility
Key inclusion criteria
Males and Females
Aged 18+ years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Antibiotic use in last 2 months
Previous shoulder joint surgery
Receiving treatment for acne in either a topical or systemic form
Eczema or other skin condition at the shoulder region

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 7367 0
New Zealand
State/province [1] 7367 0

Funding & Sponsors
Funding source category [1] 292451 0
Hospital
Name [1] 292451 0
Wellington Hospital Orthopaedic Department
Country [1] 292451 0
New Zealand
Primary sponsor type
Hospital
Name
Wellington Hospital Orthopaedic Department
Address
Orthopaedic Department
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 291147 0
None
Name [1] 291147 0
.
Address [1] 291147 0
.
Country [1] 291147 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293910 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 293910 0
Ethics committee country [1] 293910 0
New Zealand
Date submitted for ethics approval [1] 293910 0
23/11/2015
Approval date [1] 293910 0
Ethics approval number [1] 293910 0

Summary
Brief summary
Infection of shoulder surgery has a serious impact on a patient’s functional outcome, need for further surgery and prolonged use of antibiotics. Incidence of infection post-operatively has been reported as 0.43%-4.0% with Propionibacterium acnes being a significant pathogen (Saltzman et al 2011).

P.acnes, a slow growing gram-positive anaerobic bacillus, which resides in sebaceous glands, is thought to seed and leak throughout the shoulder region following surgical incision through the glands (Matsen et al 2013). Chlorhexidine has been identified as the most ideal skin preparation for shoulder surgery, but this is not specific for P.acnes as it does not sufficiently penetrate the dermal layer of the skin. Residual P.acnes is found on the skin up to 7-29% of the time immediately after Chlorhexidine skin preparation (Hudek et al 2014; McLorinan, 2005; Lee et al 2014). A recent study by Sabetta et al has shown a reduction of bacterial load of P. acnes on the skin following patient’s application of topical Benzoyl Peroxide gel 5% for 48 hours pre-operatively both at the beginning and the end of a surgical procedure, however this method relies heavily on patient compliance.

This study aims to test the same chemical, Benzoyl Peroxide 5%, as a preoperative skin preparation combined with Chlorhexidine at the time of surgery. This regime will be compared to Chlorhexidine alone in the same participants through using the opposite axilla/shoulder region. The primary outcome assessment will be number of positive growth of P.acnes on swabs taken pre and post preparation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61734 0
Mr Ilia Elkinson
Address 61734 0
Orthopaedic Department
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country 61734 0
New Zealand
Phone 61734 0
+64 4 385 5999
Fax 61734 0
Email 61734 0
[email protected]
Contact person for public queries
Name 61735 0
Mr Ilia Elkinson
Address 61735 0
Orthopaedic Department
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country 61735 0
New Zealand
Phone 61735 0
+64 4 385 5999
Fax 61735 0
Email 61735 0
[email protected]
Contact person for scientific queries
Name 61736 0
Mr Ilia Elkinson
Address 61736 0
Orthopaedic Department
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country 61736 0
New Zealand
Phone 61736 0
+64 4 385 5999
Fax 61736 0
Email 61736 0
[email protected]

No information has been provided regarding IPD availability


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.