Evaluation of a Novel Nasal Conformer in Pediatric Patients

East Tennessee Children's Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Cleft Lip; Nasal Surgical Procedures

Treatments: Device: use of an anatomically designed nasal conformer

Study type: Interventional

Funder types: Other

Identifiers

NCT06885801

IRB-2025-069

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Standard first, anatomic second

Other group

Description:

Patients are started with the standard nasal conformer for the first 3 months and then switched to the anatomic conformer for the second 3 months

Treatment:

Device: use of an anatomically designed nasal conformer

Anatomic first, standard second

Other group

Description:

Patients are started with the anatomic nasal conformer for the first 3 months and then switched to the standard conformer for the second 3 months

Treatment:

Device: use of an anatomically designed nasal conformer