ANZCTR - Registration

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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]

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

Condition category

Condition code

Skin

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]

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]

Proportion of participants positive for P. acnes growth in shoulder region after 14 days incubation from a skin swab.

Timepoint [1]

14 days

Secondary outcome [1]

Colony count of P.acnes on agar plate that has been cultured from a skin swab

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Wellington Hospital Orthopaedic Department

Address [1]

Wellington Hospital
Riddiford street
Newtown
Wellington 6021

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Health and Disability Ethics Committees (HDEC)

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

23/11/2015

Approval date [1]

Ethics approval number [1]

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

Mr Ilia Elkinson

Address

Orthopaedic Department
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021

Country

New Zealand

Phone

+64 4 385 5999

Fax

Ilia.Elkinson@ccdhb.org.nz

Contact person for public queries

Name

Ilia Elkinson

Address

Orthopaedic Department
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021

Country

New Zealand

Phone

+64 4 385 5999

Fax

Ilia.Elkinson@ccdhb.org.nz

Contact person for scientific queries

Name

Ilia Elkinson

Address

Orthopaedic Department
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021

Country

New Zealand

Phone

+64 4 385 5999

Fax

Ilia.Elkinson@ccdhb.org.nz

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.

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