Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000530426p
Ethics application status
Submitted, not yet approved
Date submitted
12/05/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing materials needed for skin punch and shave biopsies
Scientific title
A randomised controlled trial comparing infection rates in adult patients undergoing 2-4mm skin punch and shave biopsies with or without a sterile dressing pack
Secondary ID [1] 314414 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatological diagnosis 337431 0
Infection rate 337433 0
Condition category
Condition code
Skin 333807 333807 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants undergoing a 2-4 mm skin punch or shave biopsy at Drummoyne Dermatology (a dermatology outpatient clinic) will be randomised into two groups:

Intervention group: Biopsy performed using 2-4 mm punch or shave biopsy tool, 5% chlorhexidine solution, hyfrecator and suture material (if required) without the use of a dressing pack.

Control group: Biopsy performed as per routine clinical practice using 2mm punch or shave biopsy tool, 5% chlorhexidine solution, hyfrecator and suture material (if required) with a dressing pack. Dressing pack contains: Sterile field PE material 50 x 49cm, dressing tray, 4 plain gauze swabs 7.5x7.5cm, blue sterile field 60x60cm, 3 aqua forceps 107mm, paper dressing towel 2 ply.

The intervention being tested is the omission of a dressing pack and use of reduced materials during minor skin biopsy procedures. The biopsy will be performed by doctors working at the clinic. The strategy used to monitor adherence to the intervention is direct observation by research investigator.
Intervention code [1] 331024 0
Treatment: Devices
Comparator / control treatment
Control group: Biopsy performed as per routine clinical practice using 2 to 4 mm punch or shave biopsy tool, 5% chlorhexidine solution, hyfrecator and suture material (if required) with a dressing pack.
Control group
Active

Outcomes
Primary outcome [1] 341406 0
Incidence rate of infection following skin punch or shave biopsy.
Timepoint [1] 341406 0
7-14 days post skin biopsy
Secondary outcome [1] 447400 0
Cost of materials used during skin biopsy
Timepoint [1] 447400 0
At time of procedure
Secondary outcome [2] 447401 0
Wastage of materials
Timepoint [2] 447401 0
At time of procedure
Secondary outcome [3] 447466 0
Time-to-onset of infection symptoms following biopsy
Timepoint [3] 447466 0
measured in days post-procedure the maximum duration of follow up is 14 days

Eligibility
Key inclusion criteria
Adults 18 years or older who can provide informed medical consent
Patients needing a 2 to 4 mm skin punch or shave biopsy as determined by treating clinician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years old
Patients from a non-English speaking background without a command of English
Patients who do not have the capacity to consent
Patients who do not require 2 to 4 mm punch or shave biopsy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group assignments will be concealed in sequentially numbered, opaque, sealed envelopes, which will be stored securely. Envelopes will be opened in numerical order only after the participant has been enrolled, ensuring allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur via a computer-generated permuted block randomisation sequence to ensure balance between groups. The allocation sequence will be prepared by an independent researcher not involved in participant enrolment or assessment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318943 0
Self funded/Unfunded
Name [1] 318943 0
Dr Rebecca Saunderson
Country [1] 318943 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Saunderson - Drummoyne Dermatology
Address
Country
Australia
Secondary sponsor category [1] 321408 0
None
Name [1] 321408 0
Address [1] 321408 0
Country [1] 321408 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317549 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317549 0
Ethics committee country [1] 317549 0
Australia
Date submitted for ethics approval [1] 317549 0
25/03/2025
Approval date [1] 317549 0
Ethics approval number [1] 317549 0

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

Contacts
Principal investigator
Name 141406 0
Dr Rebecca Saunderson
Address 141406 0
Drummoyne Dermatology, 1/109 Victoria Rd, Drummoyne NSW 2047
Country 141406 0
Australia
Phone 141406 0
+61497104241
Fax 141406 0
Email 141406 0
[email protected]
Contact person for public queries
Name 141407 0
Alexandra Savage
Address 141407 0
Drummoyne Dermatology, 1/109 Victoria Rd, Drummoyne NSW 2047
Country 141407 0
Australia
Phone 141407 0
+61439543670
Fax 141407 0
Email 141407 0
[email protected]
Contact person for scientific queries
Name 141408 0
Dr Rebecca Saunderson
Address 141408 0
Drummoyne Dermatology, 1/109 Victoria Rd, Drummoyne NSW 2047
Country 141408 0
Australia
Phone 141408 0
+61497104241
Fax 141408 0
Email 141408 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.