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

Qualifiers

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

Treatments tested in this trial

  • use of an anatomically designed nasal conformer

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations