Evaluation of a Novel Nasal Conformer in Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: use of an anatomically designed nasal conformer.
- Who it may be relevant to
- Registry conditions: Cleft Lip, Nasal Surgical Procedures. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device use of an anatomically designed nasal conformer
this 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
Primary outcome measures
- Ease of use [Time frame: 6 months]
- safety of the conformer [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patient's undergoing primary cleft lip repair or release of nasal scarring
Exclusion criteria
- patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Device feasibility
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06885801 · IRB-2025-069