3D printed intranasal splint made with biomed flex 80A resin to investigate its safety and tolerability in healthy volunteers

Intranasal splint made with biomed flex 80A resin to investigate its safety and tolerability in healthy volunteers

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000354482

Enrollment

Registered

2025-04-23

Start date

2025-07-28

Completion date

2025-10-01

Last updated

2025-09-22

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

Conditions

None listed

Brief summary

The purpose of this study is to investigate the safety and tolerability of 3D printed intranasal splints in healthy participants. Who is it for? You may be eligible for this study if you are a healthy adult, without a history of surgeries to the nose. Study details All participants in this study will be asked to wear a splint in the nose continuously for 10 days and will be followed up for 30 days to see if there have been any side effects It is hoped this study will help determine if these splints are safe to use for a future randomised trial looking at whether these devices can be helpful in nasal skin cancers

Interventions

3D printed intranasal splint made with biomed flex 80A resin post skin graft reconstruction for nasal alar oncological defects. The device can be easily inserted into both nostrils and should sit in place without additional taping or supports. Participants will be advised to wear the splint for a total of 10 days continuously and advised to change to a new splint every 24 hours. Questionnaires using validated tools from the literature will be used to assess adherence to the intervention

Study design

Allocation

Non-randomised trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy unaffected volunteers from TRI (translational research institute) or PAH (Princess Alexandra Hospital). Healthy refers to individuals who do not have any significant past medical history especially relating to the nose, have not had surgery on their nose and are not due for any surgery or investigation related to their nose

Exclusion criteria

• Age >80yrs or <18yrs • Active smoking (at any quantity) or being an active smoker within the last 12 months • Recent surgeries of the nose • 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) • unable to provide informed consent for participation in the trial

Outcome results