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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the Sterility and Visibility of Surgical Marking Pens Available in Australia
Scientific title
Comparing the Sterility and Visibility of Surgical Marking Pens Available in Australia: A prospective cohort study
Secondary ID [1] 296462 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Correct-site surgery 310251 0
Condition category
Condition code
Surgery 308972 308972 0 0
Other surgery

Study type
Description of intervention(s) / exposure
Six volunteers will have both anterior thighs marked with 12 surgical marking pens.

The pens will be marking pens sold from the following companies:
Pentel (N50), Artline (90), Sharpie (Super), Covdien, DeRoyal, Viscot, Concord, Sandel, Matrix, Aspen, Medline and SMI.

The lines will be 5cm in length in parallel.

Each thigh will be washed with one of four alcohol-based surgical preparation liquids. Each wash will be performed using sterile gauze swabs and forceps in a simulated operation setting. A first coat will be allowed to dry, followed by a second coat. The volume of liquid will be approximately 150mL.

The liquids will be brown tinted 1% Iodine (w/v) with 70% isopropyl alcohol (v/v), pink tinted 0.5% chlorhexidine gluconate (w/v) with 70% isopropyl alcohol (v/v), red tinted 2% chlorhexidine gluconate (w/v) with 70% isopropyl alcohol (v/v) and untinted 70% isopropyl alcohol (v/v).

The assignment will be quasi-randomised. Volunteers will be marked and washed in a random order at volunteer discretion, and liquids will be selected at random at investigator discretion, ensuring three limbs are washed with each liquid.

The study will take place in a surgical operating theatre in a private hospital in Melbourne, Australia.

The study will be conducted by an orthopaedic registrar who will apply the pen marks and surgical prep.
Intervention code [1] 312789 0
Other interventions
Comparator / control treatment
No control group
Control group

Primary outcome [1] 307943 0
Pen ink visibility following surgical wash using Adobe Photoshop (Version
Timepoint [1] 307943 0
Assessed one minute after surgical wash.
Secondary outcome [1] 353408 0
Pen tip sterility after patient contact. Swabs will be taken of the pen tip two minutes after final use. The swab will be sent to a pathology laboratory (Alfred Hospital, Melbourne) for culture and identification.
Timepoint [1] 353408 0
Two minutes after use.

Key inclusion criteria
Fitzpatrick skin type 1 or 2
Minimal body hair on thighs
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Allergy to surgical preparation liquids
Broken skin on thighs

Study design
Purpose of the study
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Two-tailed student’s T-tests will be performed.
Sample size was based on previous studies that assessed surgical marking pen ink visibility.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 12304 0
Linacre Private Hospital - Hampton
Recruitment postcode(s) [1] 24498 0
3188 - Hampton

Funding & Sponsors
Funding source category [1] 301058 0
Name [1] 301058 0
Linacre Private Hospital
Address [1] 301058 0
12 Linacre Road, Hampton, 3188, Victoria
Country [1] 301058 0
Primary sponsor type
Edward O'Bryan
Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria
Secondary sponsor category [1] 300667 0
Name [1] 300667 0
Address [1] 300667 0
Country [1] 300667 0

Ethics approval
Ethics application status
Ethics committee name [1] 301812 0
The Avenue HREC
Ethics committee address [1] 301812 0
40 The Avenue, Windsor, 3181, Victoria
Ethics committee country [1] 301812 0
Date submitted for ethics approval [1] 301812 0
Approval date [1] 301812 0
Ethics approval number [1] 301812 0

Brief summary
This study aims to compare the quality of twelve different surgical marking pens available in Australia. Quality will be defined based on visibility of ink after surgical wash, as well as sterility of pen tips based on swab cultures. The study will be performed on six medical student volunteers. Lines will be drawn on the volunteers' thighs using marking pens, and the limbs will be washed with one of four different surgical preparation liquids. The ink visibility will be assessed using digital photographs on software (Photoshop). The pen tips will be swabbed after use for culture of organisms in a pathology laboratory.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 88194 0
Dr Edward O'Bryan
Address 88194 0
Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria
Country 88194 0
Phone 88194 0
+61 431532539
Fax 88194 0
Email 88194 0
Contact person for public queries
Name 88195 0
Dr Edward O'Bryan
Address 88195 0
Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria
Country 88195 0
Phone 88195 0
+61 431532539
Fax 88195 0
Email 88195 0
Contact person for scientific queries
Name 88196 0
Dr Edward O'Bryan
Address 88196 0
Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria
Country 88196 0
Phone 88196 0
+61 431532539
Fax 88196 0
Email 88196 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
What data in particular will be shared?
Surgical marking pen visibility data
Swab results
When will data be available (start and end dates)?
Immediately following publication to a peer-reviewed journal
No end date
Available to whom?
Case-by-case basis at the discretion of the principle investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approval by principle investigator, via electronic copy
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 50 0
Ethical approval
Citation [1] 50 0
Link [1] 50 0
Email [1] 50 0
Other [1] 50 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary