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Comparing the Sterility and Visibility of Surgical Marking Pens Available in Australia

Comparing the Sterility and Visibility of Surgical Marking Pens Available in Australia: A prospective cohort study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001795280
Enrollment
6
Registered
2018-11-02
Start date
2018-07-15
Completion date
2018-07-15
Last updated
2018-11-12

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

Conditions

None listed

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.

Interventions

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 setti

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.

Sponsors

Edward O'Bryan
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Fitzpatrick skin type 1 or 2 Minimal body hair on thighs

Exclusion criteria

Allergy to surgical preparation liquids Dermatitis Broken skin on thighs

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026