Evaluation of a Novel Nasal Conformer in Pediatric Patients
Launched by EAST TENNESSEE CHILDREN'S HOSPITAL · Mar 13, 2025
Trial Information
Current as of April 29, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new type of nasal splint, called a nasal conformer, for children who have had surgery to repair a cleft lip or to treat nasal scars. The researchers want to see how this new conformer, which is shaped to fit the natural space of the nose, compares to the standard conformer that is currently available. The study will involve two groups of patients: one group will start with the standard conformer and then switch to the new one, while the other group will do the opposite. The goal is to find out which conformer is more comfortable and easier to use, and to check for any skin problems or other complications during the healing process.
To participate in this trial, patients need to be undergoing their first surgery for cleft lip repair or nasal scar release. Unfortunately, if a patient or their parents decide not to take part, or if the doctor thinks nasal stenting isn’t suitable after surgery, they won’t be eligible. Although the trial is not yet recruiting participants, those who join can expect to help researchers learn more about these devices and how they affect healing after surgery.
Gender
ALL
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
About East Tennessee Children's Hospital
East Tennessee Children's Hospital is a leading pediatric healthcare institution dedicated to providing comprehensive medical care and advancing pediatric health through innovative research and clinical trials. With a commitment to improving the health outcomes of children, the hospital conducts rigorous clinical trials that explore new treatments and therapies across various pediatric specialties. Its team of skilled healthcare professionals collaborates closely with families and community partners to ensure the highest standards of care and safety in research initiatives, ultimately striving to enhance the quality of life for children in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported