Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001795280
Ethics application status
Approved
Date submitted
30/10/2018
Date registered
2/11/2018
Date last updated
2/11/2018
Date data sharing statement initially provided
2/11/2018
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
None
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

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
Primary outcome [1] 307943 0
Pen ink visibility following surgical wash using Adobe Photoshop (Version 19.1.5.722).
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.

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

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/07/2018
Date of last participant enrolment
Anticipated
Actual
15/07/2018
Date of last data collection
Anticipated
Actual
19/07/2018
Sample size
Target
6
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
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
Hospital
Name [1] 301058 0
Linacre Private Hospital
Country [1] 301058 0
Australia
Primary sponsor type
Individual
Name
Edward O'Bryan
Address
Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria
Country
Australia
Secondary sponsor category [1] 300667 0
None
Name [1] 300667 0
Address [1] 300667 0
Country [1] 300667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301812 0
The Avenue HREC
Ethics committee address [1] 301812 0
Ethics committee country [1] 301812 0
Australia
Date submitted for ethics approval [1] 301812 0
31/03/2018
Approval date [1] 301812 0
02/05/2018
Ethics approval number [1] 301812 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of the principle investigator

Conditions for requesting access:
• -

What individual participant data might be shared?
• Surgical marking pen visibility data
Swab results

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication to a peer-reviewed journal
No end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approval by principle investigator, via electronic copy

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
50Ethical approval    Study-related document.pdf



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.