Comparison of the consequences of simple nasal fracture reduction with over reduction in patients with nasal fractures.
Determining the level of patients' satisfaction with the appearance of the nose based on the VAS scale in the simple reduction group.
Determining the level of patients' satisfaction with the appearance of the nose based on the VAS scale in the Over Reduction reduction group.
Design
Clinical trial with control group with parallel group, double-blind, randomized, on 40 patients. Excel random function was used for randomization.
Settings and conduct
A clinical trial will be performed on patients referred to Besat Hospital in Hamadan. 40 patients who have suffered a nasal fracture in the last 10 days are randomly divided into two groups. In the first group, which includes 20 patients, nasal implantation It is done simply and in the second group, the placement is done by Over reduction method. The photograph is taken before the placement and 3 months after the placement and is analyzed by an evaluator who has been blinded. The VAS questionnaire is completed by patients and the above data are analyzed by SPSS software.
Participants/Inclusion and exclusion criteria
Having a broken nose during the last 7 to 10 days and no edema and swelling of the nose .
Age 15 to 50 years.
Intervention groups
Patients are divided into two groups. In the first group, simple nasal reduction is performed and in the second group, over reduction is performed.
Main outcome variables
Nasal congestion/ Appearance /Satisfaction
General information
Reason for update
Acronym
HNFR
IRCT registration information
IRCT registration number:IRCT20220509054800N1
Registration date:2022-05-18, 1401/02/28
Registration timing:prospective
Last update:2022-05-18, 1401/02/28
Update count:0
Registration date
2022-05-18, 1401/02/28
Registrant information
Name
Sajad Hadian
Name of organization / entity
Hamedan University of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 7331
Email address
sajad.hadianp @yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-02-18, 1401/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of simple nasal fracture reduction with over reduction outcoms in patients with nasal fractures.
Public title
Over reduction in nasal fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a nose fracture during the last 7 to 10 days and no edema and swelling of the nose.
Minimum 15 years and maximum 50 years.
Absence of edema and swelling of the nose.
Exclusion criteria:
Open nose fracture.
Severe nasal fracture.
Need septoplasty.
Hematoma septum.
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients by simple, individual randomization, Excel statistical software.
After registering the details in Excel software, the patients are randomly divided into two groups A and B by this software. Group A is the control group and group B is the case group.
Patients are completely randomly divided into two groups by lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the evaluator who compares the outcome between the two groups are kept blind.
Patients are randomly divided into two groups after obtaining informed consent and full explanation of the research. The evaluating physician does not know which group the patients belong to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences.
Street address
No.26،East etemadieh Blvd،Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6515957581
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.UMSHA.REC.1400.129
Health conditions studied
1
Description of health condition studied
Nasal bon fracture
ICD-10 code
S02.2
ICD-10 code description
Fracture of nasal bones.
Primary outcomes
1
Description
Patient satisfaction with the appearance of the nose.
Timepoint
Before implantation of nasal bone fracture and 3 months after implantation of implantation of nasal bone fracture and 3 months after implantation.
Method of measurement
Visual Analogue Scales.
2
Description
Nasal congestion
Timepoint
Before surgery and 3 months after surgery.
Method of measurement
Nostad questionnaire
3
Description
Complications of treatment after surgery such as septal hematoma and tears and any complications that occur after surgery.
Timepoint
After operation
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 patients undergoing over reduction reduction surgery.In this method, the broken nasal bone, after returning to its place, moves a little further away from its place, which returns to its original place if it returns.
Category
Treatment - Surgery
2
Description
Control group: 20 patients undergoing simple nasal bone reduction surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Sajad Hadian
Street address
No.26،East Etemadieh Blvd.Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6515955871
Phone
+98 81 3823 7331
Email
sajad.hadianp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rohallah Abasi
Street address
No.26،East Etemadieh Blvd.Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6515955871
Phone
+98 81 3823 7331
Email
sajad.hadianp@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sajad Hadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.26،East Etemadieh Blvd.Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6515955871
Phone
+98 81 3823 7331
Email
sajad.hadianp@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sajad Hadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.26،East Etemadieh Blvd.Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6515955871
Phone
+98 81 3823 7331
Email
sajad.hadianp@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sajad Hadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.26،East Etemadieh Blvd.Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6515955871
Phone
+98 81 3823 7331
Email
sajad.hadianp@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available