Evaluation of a Novel Nasal Conformer in Pediatric Patients
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorEast Tennessee Children's Hospital
About this trial
This study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. This will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. This study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient's undergoing primary cleft lip repair or release of nasal scarring
Disqualifiers
patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate
Trial design
Design model
Crossover
Treatments tested in this trial
use of an anatomically designed nasal conformer
Devicethis study will evaluate the use of a nasal conformer that has been designed to match the internal airway anatomy of the anterior nose rather than the standard hollow, conical conformer currently available on the market
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Standard first, anatomic secondOther 1 intervention
Group B: Anatomic first, standard secondOther 1 intervention
Trial outcomes
Primary outcomes
1
Ease of use
The patients or (parents for younger patients) will complete a questionnaire at the end of 3 months and 6 months after using each of the various types of conformer. These questionnaires will consist of a grading scale evaluating each of the conformer is a based on the ease of cleaning, inserting, and keeping the stent in place is evaluated
Time frame
6 months2
safety of the conformer
The patients or (parents of younger patients) will complete a questionnaire at the end of 3 months and 6 months after using each of the various types of conformer. The these will give them the opportunity to report the occurrence of adverse events such as skin rashes, skin irritation, skin breakdown, or stent breakage.
Time frame
6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: