The use of internal nasal dilators to improve breathing and symmetry after rhinoplasty surgery
| ISRCTN | ISRCTN13835640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13835640 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Southlake Regional Health Centre – Research Ethics Board |
| Funder | Investigator initiated and funded |
- Submission date
- 03/11/2025
- Registration date
- 04/11/2025
- Last edited
- 04/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Some people who have nose reshaping surgery (rhinoplasty) find it harder to breathe or notice that their nostrils look uneven while they heal. This study looked at whether using a small, soft device placed inside the nose could help improve breathing comfort and make the nostrils look more even during recovery.
Who can participate?
Adults who had septorhinoplasty (a type of nose surgery that includes reshaping the septum) at Southlake Regional Health Centre in Ontario, Canada, were invited to take part.
What does the study involve?
Participants were randomly placed into one of two groups. One group used a soft silicone nasal device inside their nose for one week all day, and then only at night for three months. The other group received standard care without the device. Everyone had the same surgery and follow-up visits. Participants filled out surveys about their breathing and how their nose looked before surgery, and again at 3 and 12 months after surgery.
What are the possible benefits and risks of participating?
The nasal device may help improve breathing and nostril appearance during healing. The study also looked at how comfortable the device was and whether it caused any side effects. Risks were expected to be low, but any discomfort or issues with the device were recorded.
Where is the study run from?
The study was carried out at Southlake Regional Health Centre in Ontario, Canada.
When is the study starting and how long is it expected to run for?
The study began in December 2022 and is expected to finish in May 2025.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Raisa Chowdhury, raisa.chowdhury@mail.mcgill.ca
Contact information
Public, Scientific, Principal investigator
6553 Rue Léon Derome
Montréal
H1M 1S3
Canada
 ORCID ID |
0009-0000-5433-5808 |
|---|---|
| Phone | 5148063787 |
| raisa.chowdhury@mail.mcgill.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized single-blinded parallel-group controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The functional and aesthetic effects of internal nasal dilator device use following septorhinoplasty: a randomized, single-blinded controlled trial |
| Study acronym | IND-R Trial |
| Study objectives | Primary Objective: To determine whether the use of an internal nasal dilator (IND) during the postoperative healing period after septorhinoplasty improves patient-reported nostril symmetry compared with standard postoperative care alone. Secondary Objectives: 1. To assess whether IND use enhances functional breathing outcomes as measured by the functional domain of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS). 2. To evaluate aesthetic satisfaction and overall quality of life using the SCHNOS aesthetic domain and total score. 3. To measure device comfort, adherence, and safety, including incidence of mucosal irritation, ulceration, or infection. 4. To explore whether baseline characteristics (e.g., presence of rhinitis, surgical indication, or approach) influence the functional or aesthetic effects of IND use. |
| Ethics approval(s) |
Approved 01/12/2022, Southlake Regional Health Centre Research Ethics Board (596 Davis Dr, Newmarket, L3Y 2P9, Canada; +1 (905) 895-4521; moreinfo@ontariohealthathome.ca), ref: S-015-2223 |
| Health condition(s) or problem(s) studied | Postoperative nasal obstruction and nostril asymmetry after septorhinoplasty (rhinoplasty). The study examines whether internal nasal dilators improve functional breathing outcomes and aesthetic nasal symmetry during postoperative healing. |
| Intervention | Participants in the intervention group received a soft, silicone internal nasal dilator inserted on postoperative Day 3 and worn continuously for 1 week, then nightly through 3 months, in addition to standard postoperative care. The control group received standard care alone. The device was intended to support the internal nasal valve, improve breathing, and maintain nostril-base symmetry during healing. The study used a 1:1 randomized, single-blinded, parallel-group design with follow-up to 12 months. Participants were randomized 1:1 to the internal nasal dilator plus standard care group or standard care only using a computer-generated randomization sequence. Allocation concealment was maintained using sequentially numbered, sealed opaque envelopes prepared by an independent coordinator who was not involved in participant recruitment, surgery, or data analysis. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Internal nasal dilator |
| Primary outcome measure(s) |
Patient-reported nostril symmetry measured using a 5-point Likert scale (0 = perfectly symmetrical; 4 = very asymmetrical) at 3 and 12 months after septorhinoplasty |
| Key secondary outcome measure(s) |
1. SCHNOS functional domain scores (nasal breathing) at baseline, 3, and 12 months. |
| Completion date | 01/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 128 |
| Total final enrolment | 112 |
| Key inclusion criteria | 1. Adults aged 16–55 years undergoing primary open or closed septorhinoplasty (cosmetic, functional, or combined) 2. Provide informed consent 3. Able to complete questionnaires in English or French 4. Comply with scheduled follow-up visits at baseline, 3 and 12 months |
| Key exclusion criteria | 1. Cleft-related nasal deformities 2. Planned alar base reduction 3. Revision rhinoplasty 4. Prior nasal surgery 5. Psychiatric or cognitive disorders affecting compliance 6. Concurrent use of internal nasal stents 7. Active nasal infection 8. Silicone allergy 9. Pregnancy or lactation |
| Date of first enrolment | 15/01/2023 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- Canada
Study participating centre
Newmarket
L3Y 2P9
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Individual participant data will not be shared publicly. De-identified data may be available upon reasonable request to the corresponding author, in accordance with institutional and ethics board policies. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 04/11/2025 | No | No |
Additional files
- 48355 Study Protocol_Internal Nasal Dilator.pdf
- Protocol file
Editorial Notes
03/11/2025: Trial's existence confirmed by Southlake Regional Health Centre Research Ethics Board.
