ANZCTR - Registration

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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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Skin cancer

Condition category

Condition code

Cancer

Non melanoma skin cancer

Surgery

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]

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]

Percentage of graft take

Timepoint [1]

day 21 +/- 3 post-operatively

Primary outcome [2]

Aesthetic outcomes. this will be assessed as a composite outcome

Timepoint [2]

day 6+/-1, day 21 +/-3, day 45 +/-3 post-operatively

Primary outcome [3]

Functional outcomes (this is a primary outcome). this will be assessed as a composite outcome

Timepoint [3]

day 6+/-1, day 21 +/-3, day 45 +/-3 post-operatively

Secondary outcome [1]

Medical device failure and defects

Timepoint [1]

day 6+/-1, day 21 +/-3, day 45 +/-3 post-operatively

Secondary outcome [2]

Device tolerability (this is a primary outcome)

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Princess Alexandra Hospital

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Metro South Health

Address [2]

Country [2]

Australia

Primary sponsor type

Government body

Name

Metro South Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

https://metrosouth.health.qld.gov.au/research/about-us/hrec

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2025

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study aims to investigate whether 3D printed patient-matched intranasal splints are effective in improving outcomes of full-thickness skin grafts on nasal oncological defects.

Who is it for?
You may be eligible for this study if you are an adult patient presenting to the Princess Alexandra Hospital via the Skin Lesion Assessment and Management clinic with a skin cancer localised to the nasal alar requiring surgical excision and reconstruction with a full thickness skin graft.

Study details
Participants will be randomly allocated to either receive 3D printed splints in their nostrils immediately post-operatively which will be changed daily for 10 days, or an intranasal merocel pack which will be inserted post-operatively and remain in place for 7 days, or no intranasal dressing. Participants will be asked to complete questionnaires on aesthetic and functional outcomes of surgery for up to 45 days post-operatively.

It is hoped that findings from this study will contribute to new methods of improving rates of graft take on the nasal alar in patients with skin cancer causing nasal defects.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michael Wagels

Address

Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 0406183619

Fax

[email protected]

Contact person for public queries

Name

Amy Yoon

Address

Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 0451817118

Fax

[email protected]

Contact person for scientific queries

Name

Amy Yoon

Address

Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 0451817118

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24615	Study protocol	N/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.

Trial Review

Documents added manually

Documents added automatically