Ear Malformation
Conditions
Brief summary
Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group
Interventions
DEVICECustom-made silicone device
Correction of deformation using the custom-made silicone device
DEVICEadjustable Earwell device
Correction of deformation using the adjustable Earwell device
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No
Inclusion criteria
* Newborn, age between 8 days and 1 month * newborn with ear malformation
Exclusion criteria
* Total chondrocutaneous agenesis of the ear * polymalformative syndrome * age greater than 4 weeks * parental refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective ear deformation score | baseline and 1 year after | Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group. |
Countries
France
Contacts
CONTACTAlexis VEYSSIERE
CONTACTVEYSSIERE
Outcome results
None listed