Cleft Lip, Nasal Surgical Procedures
Conditions
Brief summary
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
DEVICEuse 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
Sponsors
East Tennessee Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use | 6 months | 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 |
| safety of the conformer | 6 months | 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. |
Countries
United States
Outcome results
None listed