Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000369426p
Ethics application status
Submitted, not yet approved
Date submitted
8/04/2025
Date registered
28/04/2025
Date last updated
28/04/2025
Date data sharing statement initially provided
28/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient-matched 3D printed Intranasal splint made with biomed flex 80A resin post skin graft reconstruction for nasal alar oncological defects to investigate its efficacy in improving rates of graft take
Scientific title
Patient-matched 3D printed Intranasal splint made with biomed flex 80A resin post skin graft reconstruction for nasal alar oncological defects to investigate its efficacy in improving rates of graft take
Secondary ID [1] 314160 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer 336993 0
Condition category
Condition code
Cancer 333457 333457 0 0
Non melanoma skin cancer
Surgery 333458 333458 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients receiving surgery at the Princess Alexandra Hospital for skin cancers of the nose that are reconstructed with full thickness skin grafts will be recruited. All participants will get a 3D surface scan pre-operatively. This will help determine the best matched splint from our selection of different splints of different shapes and sizes. The splints are manufactured using biomed flex 80A resin material. The splint will be inserted into both nostrils immediately post-operatively and should stay in place with nil additional dressings or supports. Patients will be advised to wear the splint for 10 days, changing the splint every day. Questionnaires using validated tools from the literature will be used to assess adherence
Intervention code [1] 330753 0
Treatment: Devices
Comparator / control treatment
The intervention will be compared to two groups of patients. The first will be with no intranasal pack or splint which is the standard of care, the second will be the control group which will be an intranasal merocel pack. Intranasal merocel pack involves inserting a gauze cylinder made from polyvinyl acetal (PVA) into the nasal cavity to provide some intranasal splinting of the nose during healing. All participants will get their operation as they usually would regardless of whether they were participants of this study or not. All participants will have paraffin ointment applied to their graft with no other external dressing. Those in the control group will have their intranasal merocel pack applied immediately postoperatively by the surgeon and this will remain in situ for 7 days until their graft check with no replacement of the pack after this.
Control group
Active

Outcomes
Primary outcome [1] 341031 0
Percentage of graft take
Timepoint [1] 341031 0
day 21 +/- 3 post-operatively
Primary outcome [2] 341032 0
Aesthetic outcomes. this will be assessed as a composite outcome
Timepoint [2] 341032 0
day 6+/-1, day 21 +/-3, day 45 +/-3 post-operatively
Primary outcome [3] 341215 0
Functional outcomes (this is a primary outcome). this will be assessed as a composite outcome
Timepoint [3] 341215 0
day 6+/-1, day 21 +/-3, day 45 +/-3 post-operatively
Secondary outcome [1] 445878 0
Medical device failure and defects
Timepoint [1] 445878 0
day 6+/-1, day 21 +/-3, day 45 +/-3 post-operatively
Secondary outcome [2] 446215 0
Device tolerability (this is a primary outcome)
Timepoint [2] 446215 0
day 6+/-1, day 21 +/-3, day 45 +/-3 post-operatively

Eligibility
Key inclusion criteria
patients presenting to the Princess Alexandra Skin Lesion Assessment and Management clinic with a skin cancer localised to the nasal alar requiring surgical excision with a full thickness skin graft
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age >80yrs or <18yrs
• Active smoking (at any quantity)
• Previous skin grafting on the nasal alar
• Previous surgical intervention significantly compromising the integrity of the nasal architecture in that a nasal packing/splinting technique is contra-indicated
• Use of the proposed medical device is contra-indicated for patient safety (i.e. due to patient allergies)
• Patient is unable to attend scheduled follow up visits to review graft integrity
• Patient is unable to provide informed consent for participation in the trial
• Full-thickness nasal alar lesion/defect

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
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
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318671 0
Hospital
Name [1] 318671 0
Princess Alexandra Hospital
Country [1] 318671 0
Australia
Funding source category [2] 318672 0
Government body
Name [2] 318672 0
Metro South Health
Country [2] 318672 0
Australia
Primary sponsor type
Government body
Name
Metro South Health
Address
Country
Australia
Secondary sponsor category [1] 321094 0
None
Name [1] 321094 0
Address [1] 321094 0
Country [1] 321094 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317285 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317285 0
Ethics committee country [1] 317285 0
Australia
Date submitted for ethics approval [1] 317285 0
08/04/2025
Approval date [1] 317285 0
Ethics approval number [1] 317285 0

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

Contacts
Principal investigator
Name 140566 0
Dr Michael Wagels
Address 140566 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 140566 0
Australia
Phone 140566 0
+61 0406183619
Fax 140566 0
Email 140566 0
[email protected]
Contact person for public queries
Name 140567 0
Amy Yoon
Address 140567 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 140567 0
Australia
Phone 140567 0
+61 0451817118
Fax 140567 0
Email 140567 0
[email protected]
Contact person for scientific queries
Name 140568 0
Amy Yoon
Address 140568 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 140568 0
Australia
Phone 140568 0
+61 0451817118
Fax 140568 0
Email 140568 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24615Study protocolN/A   Protocol - RCT Study - V2.docx



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.