Fracture NoseNCT06737133
Early Management of Fracture Nose in Pediatric Patients
A study testing Surgery in people with Fracture Nose, run by Sohag University.
Trial summary
Introduction: Nasal fractures are common components of the facial skeleton injuries. Nasal bone fractures are the most common type of facial fracture (1), and the third most common fracture of the human skeleton (2). Nasal fractures are frequently associated with cartilaginous and soft tissue injuries. Read more about this study
- Who is it for?
- Ages 1 day to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture Nose
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ranged from since birth to 12 years old
- Isolated nasal fracture
- Presented from time of trauma up to 5 days
Who cannot join
- Multiple facial fractures
- Age more than 12 years old
- Systemic diseases
- Any hematological disorders
About this study
Introduction:
Nasal fractures are common components of the facial skeleton injuries. Nasal bone fractures are the most common type of facial fracture (1), and the third most common fracture of the human skeleton (2).
Read more
Nasal fractures are frequently associated with cartilaginous and soft tissue injuries. The incidence of post- traumatic nasal deformity, if left untreated, varies from 14% to 50% (3).The management of nasal injuries since Maliniac's description of the management of nasal fractures in 1947 has seen several variations (3) .
The functional and cosmetic problems arising may sometimes necessitate intricate surgical procedures to restore the anatomy. Due to constraints of resources and the range of services provided, these injuries are typically managed . Most commonly, nasal bone fractures are sustained in fights (34%), accidents (28%), and sports (23%). A 2009 study of 236 patients with facial fractures incurred while playing sports determined that fractures of the nasal bone were most common (4) . In children, nasal fractures are most commonly due to falls. In a study of 100 children with traumatic nasal deformity, Liu et al determined that such injuries were most often the result of sports-related trauma (28%), with accidental trauma (21%), interpersonal violence (10%), motor vehicle collisions (6%), and alcohol- related trauma (2%) being the next most common reasons for injury (5) . The possibility of child abuse should be considered in every child presenting with a nasal fracture The prognosis of nasal bone fracture is depend on: If NBFs are treated within correct time parameters, patients should anticipate a successful healing and proper nasal alignment. Communication between the surgeon, ENT physician, and primary care physician or emergency physician is crucial to the treatment plan (6). The greatest complications from reduction are malunion and cosmetic concerns. Incidence of complications is highest in bilateral fractures, comminuted fractures, and fractures with severe nasal septum deviation (7).
- Conditions
- Fracture Nose
- Being tested
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Rhinoplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the outer framework of the nose after trauma
Early correction of nasal fractures to preserve the outer framework of the nose after trauma achieving the best result aiming to minimize rhinoplasty further on ,measuring the nasal bone length pre and postoperative
Measured: One year and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture NoseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Asem Althany Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737133
- Sponsor's protocol ID
- Soh-Med-24-11-07MS
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Management of Fracture Nose in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06737133
- Acronym / sponsor ID
- Soh-Med-24-11-07MS
- Conditions
- Fracture Nose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction:
Nasal fractures are common components of the facial skeleton injuries. Nasal bone fractures are the most common type of facial fracture (1), and the third most common fracture of the human skeleton (2).
Nasal fractures are frequently associated with cartilaginous and soft tissue injuries. The incidence of post- traumatic nasal deformity, if left untreated, varies from 14% to 50% (3).The management of nasal injuries since Maliniac's description of the management of nasal fractures in 1947 has seen several variations (3) .
The functional and cosmetic problems arising may sometimes necessitate intricate surgical procedures to restore the anatomy. Due to constraints of resources and the range of services provided, these injuries are typically managed . Most commonly, nasal bone fractures are sustained in fights (34%), accidents (28%), and sports (23%). A 2009 study of 236 patients with facial fractures incurred while playing sports determined that fractures of the nasal bone were most common (4) . In children, nasal fractures are most commonly due to falls. In a study of 100 children with traumatic nasal deformity, Liu et al determined that such injuries were most often the result of sports-related trauma (28%), with accidental trauma (21%), interpersonal violence (10%), motor vehicle collisions (6%), and alcohol- related trauma (2%) being the next most common reasons for injury (5) . The possibility of child abuse should be considered in every child presenting with a nasal fracture The prognosis of nasal bone fracture is depend on: If NBFs are treated within correct time parameters, patients should anticipate a successful healing and proper nasal alignment. Communication between the surgeon, ENT physician, and primary care physician or emergency physician is crucial to the treatment plan (6). The greatest complications from reduction are malunion and cosmetic concerns. Incidence of complications is highest in bilateral fractures, comminuted fractures, and fractures with severe nasal septum deviation (7).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ranged from since birth to 12 years old
- Isolated nasal fracture
- Presented from time of trauma up to 5 days
Key exclusion criteria (4 listed)
- Multiple facial fractures
- Age more than 12 years old
- Systemic diseases
- Any hematological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryRhinoplasty | Procedure or surgery | – |
Primary outcome
Measure of the outer framework of the nose after trauma
Time frame: One year and 3 months
Early correction of nasal fractures to preserve the outer framework of the nose after trauma achieving the best result aiming to minimize rhinoplasty further on ,measuring the nasal bone length pre and postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Fracture Nose, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the outer framework of the nose after trauma (time frame: One year and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.