CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
ConditionEar Malformation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorUniversity Hospital, Caen
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newborn, age between 8 days and 1 month
newborn with ear malformation
Disqualifiers
Total chondrocutaneous agenesis of the ear
polymalformative syndrome
age greater than 4 weeks
parental refusal
Trial design
Design model
Parallel
Treatments tested in this trial
Custom-made silicone device
DeviceCorrection of deformation using the custom-made silicone device
adjustable Earwell device
DeviceCorrection of deformation using the adjustable Earwell device
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Subjective ear deformation score
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.
Time frame
baseline and 1 year afterSponsors and contacts
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Source ClinicalTrials.gov