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Pilot Study- Comparing two surgical preparations Chlorhexidine 2% and Chlorhexidine 2% with Benzyol peroxide 5% for reduction of Propionobacterium acnes in the shoulder region.

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. .

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001295538
Enrollment
50
Registered
2015-11-27
Start date
2016-12-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Wellington Hospital Orthopaedic Department
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Males and Females Aged 18+ years

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026