The comparison of close reduction of nasal bone fracture, the classic methods of valsham with hands reduction in Patients referring to Khatam-al-Anbia Hospital in Zahedan district.
The goal of the single center and double blind study is determination of the success of nasal reduction and The comparison of close reduction of nasal bone fracture, the classic methods of valsham with hands reduction in Patients referring to Khatam-al-Anbia Hospital in Zahedan district.135 patients were chosen randomly and were divided with the method Random blocks.Inclusion criteria: all patients aged 5 to 50 years with nasal fracture that refering to Khatam-al-Anbia Hospital in Zahedan district.
Exit criteria: open fracture, fracture with the rupture of the skin and tissue damage,depress fracture,old fracture,septum damage at the same time. after anesthesia with mask in control group ,patients undergo a nasal fracture close reduction with the classic method of valsham(with the use of valsham blades) and the Intervention group,patients undergo a nasal fracture reduction with hand(tenar).the intensity and severity of the impact depending on the surgeon's judgment.the Success in nasal reduction under supervision examiner one month after the intervention is the main goal of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017103137119N1
Registration date:2017-11-16, 1396/08/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Samaneh Keykha
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 4152
Email address
s.keykha@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology of Zahedan university of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of close reduction of nasal bone fracture, the classic methods of valsham with hands reduction in Patients referring to Khatam-al-Anbia Hospital in Zahedan district.
Public title
Reduction of nasal fracture with hands and comparison with reduction valsham
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients aged 5 to 50 years with nasal fracture that refering to Khatam-al-Anbia Hospital in Zahedan district.
Exclusion criteria: open fracture; fracture with the rupture of the skin and tissue damage; depress fracture; old fracture; septum damage at the same time.
Age
From 4 years old to 49 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences.
Street address
zahedan-The docte Hesabi Account-University of Medical Sciences.
City
Zahedan
Postal code
9816743463
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.ZAUMS.REC.1395.139
Health conditions studied
1
Description of health condition studied
Fracture of nasal bone
ICD-10 code
S02.2
ICD-10 code description
Fracture of nasal bone
Primary outcomes
1
Description
Success in nasal reduction under supervision examiner
Timepoint
one month after the intervention
Method of measurement
assessment by surgeon according to physical examination
Secondary outcomes
1
Description
Success in nasal reduction from the perspective of the patient in two methods
Timepoint
one month after the intervention
Method of measurement
questionnaire
2
Description
required tampons in two methods
Timepoint
after the reduction
Method of measurement
surgeon's observation
3
Description
the amount of bleeding during the reduction in two methods
Timepoint
during the reduction
Method of measurement
surgeon's observation
Intervention groups
1
Description
Intervention group:patients undergo a nasal fracture reduction with hand(tenar).the intensity and severity of the impact depending on the surgeon's judgment
Category
Treatment - Surgery
2
Description
control group::patients undergo a nasal fracture close reduction with the classic method of valsham(with the use of valsham blades)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital
Full name of responsible person
Docter Gholamali Dashti
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University Of Medical Sciences
Full name of responsible person
Ghazaleh Ashrafzadeh
Street address
Deputy Of Research and Technology, Zahedan University Of Medical Sciences, The Docter Hesabi Account, Zahedan University Of Medical Sc
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University Of Medical Sciences
Full name of responsible person
Samaneh Keykha
Position
Medical Student
Other areas of specialty/work
Street address
Zahedan University Of Medical Sciences, The Docter Hesabi Account, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3342 4152
Fax
Email
s.keykha@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khatam Al Anbia Hospital
Full name of responsible person
Docter Gholamali Dashti
Position
Surgeon and ENT
Other areas of specialty/work
Street address
Jamejam Boulevard, Zahedan
City
Zahedan
Postal code
9815733169
Phone
+98 54 3323 9762
Fax
Email
drdashti50@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Samaneh Keykha
Position
Medical Student
Other areas of specialty/work
Street address
City
Zahedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)