None listed
Conditions
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.
Interventions
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
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
Sponsors
Metro South Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
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
Outcome results
None listed