Evaluation of a Novel Nasal Conformer in Pediatric Patients

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.

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Key information

Conditions

Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Nasal Surgical Procedures Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

use of an anatomically designed nasal conformer

Device

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 outcomes

Ease of use

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Justin Daggett, MD

CONTACT

[email protected]

18658244939

Sponsors and collaborators

Lead sponsor

East Tennessee Children's Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: Mar 20, 2025
Registry last updated: Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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