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Assay effective cryo therapy in reduce bruising and Swelling nose and sub optic in Patients undergoing operation surgery rhinoplasty in Martyr Rajai Hospital gachsaran2013

Protocol summary

Summary
Introduction: Cryotherapy has a long history of use in medicine. Clinical benefits Cryotherapy methods, including ease of use, bone mineral structure, and reduce the risk of infection. This procedure can be repeated without permanent side effects and the local area be used. Findings can be used for edema and swelling around the nose Cryotherapy greatly reduced, leading to a saving anti-inflammatory drugs with many side effects and faster recovery of the patient. In general focal cryotherapy in selected patients to reduce side effects. This study cryotherapy impact on reducing bruising and swelling around the nose and under the eyes of patients who undergo rhinoplasty is performed in the hospital martyr Rajai Gachsaran. Methods: This study is a clinical a martyr Rajai Hospital Gachsaran for rhinoplasty was performed on 70 patients. Demographic data questionnaire, registration form and information about how to measure edema and ecchymosis were specific for each patient separately regulated. Patients in the intervention and control groups of 10 teeth in 35 patients were divided into two groups. All patients received general anesthesia, closed rhinoplasty procedure was identical. For groups before, during and after surgery were Cryotherapy, all patients received the same postoperative care rhinoplasty. Cryotherapy groups with special pads were done in the cold, and the control group did not receive any Cryotherapy or specific drug used. View the amount of swelling and bruising after Cryotherapy after rhinoplasty surgery by someone who already had been taught about the swelling and bruising, and previous view of the position had been determined. Calibrated using the standard tools of ecchymosis and swelling were scored, and the data were recorded in the registration form. The amount of swelling and bruising in the intervention and control groups on both the right and left eyes at intervals of 0.5, 1, 6 and 24 hours after surgery was measured. The data collected by statistical software spss version 20 and independent t-test and test Greenhouse - Gysr were analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013052613460N1
Registration date: 2013-09-07, 1392/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Hossein Kavyani
Name of organization / entity
Isfahan University Vahd khovrasgan
Country
Iran (Islamic Republic of)
Phone
+98 74 2222 5031
Email address
h.kavyani@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal is finance
Expected recruitment start date
2013-07-24, 1392/05/02
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assay effective cryo therapy in reduce bruising and Swelling nose and sub optic in Patients undergoing operation surgery rhinoplasty in Martyr Rajai Hospital gachsaran2013
Public title
Effective cryo therapy in reduce bruising and Swelling
Purpose
Supportive
Inclusion/Exclusion criteria
Exclusion criteria: 1 - In the study, patients had to be admitted to the hospital martyr Rajai Gachsaran. 2 - Patients should be settled Gachsaran 24 hours after surgery or rhinoplasty are staying in the city Gachsaran. 3 - Patients must be willing to participate in the study. 4 - Minimum 20 years and maximum age of patients is 40 years. 5 - Patients who do not express any disease that might interfere with rhinoplasty surgery. 6 - patients are referred for surgery rhinoplasty. 7 - Ability to answer the questions. Exclusion criteria: 1 - requests that the subjects withdrew from the study during the preoperative rhinoplasty questionnaire to analyze the data. 2 - Failure to comply with the instructions given to the patients before treatment and after rhinoplasty.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan - Gate Shiraz - Isfahan University of Medical Sciences
City
Isfahan
Postal code
75818-16664
Approval date
2013-06-26, 1392/04/05
Ethics committee reference number
492011

Health conditions studied

1

Description of health condition studied
Swelling and bruising
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Place of ecchymosis
Timepoint
0.5, 1 ,6 ,24 hours
Method of measurement
The method of determining the degree of ecchymosis around the eyes and under the terms of the observed

2

Description
Edema or swelling around the nose and under the eyes
Timepoint
5.0,1,6,24 hours
Method of measurement
Indentation of millimeters

Secondary outcomes

1

Description
Swelling and edema
Timepoint
5.0, 1, 6, 24 hours
Method of measurement
Indentation of millimeters

Intervention groups

1

Description
This study is a clinical trial in 35 patients from the hospital martyr Rajai GACHSARAN for rhinoplasty (intervention group) were performed. Demographic data questionnaire, registration form and information about how to measure edema and ecchymosis were specific for each patient separately regulated. All patients received general anesthesia, closed rhinoplasty procedure was identical. For, before, during and after surgery were cryotherapy, all patients received the same postoperative care rhinoplasty.. Calibrated using the standard tools of ecchymosis and swelling were scored, and the data were recorded in the registration form. The amount of swelling and bruising in the intervention and control groups on both the right and left eyes at intervals of 0/5, 1, 6 and 24 hours after surgery was measured. The data collected by statistical software spss version 20 and independent t-test and test Greenhouse - Gysr were analyzed.
Category
Treatment - Other

2

Description
This study is a clinical trial in 35 patients from the hospital martyr Rajai GACHSARAN for rhinoplasty (control group) was performed. Demographic data questionnaire, registration form and information about how to measure edema and ecchymosis were specific for each patient separately regulated. All patients received general anesthesia, closed rhinoplasty procedure was identical. For, before, during and after surgery cryotherapy not used, all patients received the same postoperative care rhinoplasty. Calibrated using the standard tools of ecchymosis and swelling were scored, and the data were recorded in the registration form. Control the amount of swelling and bruising on both the right and left eyes at intervals of 0/5, 1, 6 and 24 hours after surgery was measured. The data collected by statistical software spss version 20 and independent t-test and test Greenhouse - Gysr were analyzed
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyr Rajai Hospital Gachsaran
Full name of responsible person
Hossein Kavyani
Street address
Martyr Rajai Hospital Gachsaran
City
Gachsaran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences Branch
Full name of responsible person
Dr. Peiam Najafi
Street address
Five Hundred Machines left the Sation Martyr st. Nazmi
City
Khorasgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences Branch
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
Isfahan Azad University khorasgan unit
Full name of responsible person
Hossein Kavyani
Position
MSc student
Other areas of specialty/work
Street address
Isfahan Azad University khorasgan unit
City
Khorasgan
Postal code
75818-16664
Phone
+98 31 1535 4018
Fax
Email
hosseinkavyani7@yahoo.com; h.kavyani@khuisf.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iasouj University of Medical Sciences
Full name of responsible person
Babak Paryavi
Position
ENT specialist
Other areas of specialty/work
Street address
Martyr Rajai Hospital Gachsaran
City
Gachsaran
Postal code
Phone
+98 74 2222 4711
Fax
Email
mahdiamohammadi2@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan Azad University khorasgan unit
Full name of responsible person
Hossein Kavyani
Position
MSc student
Other areas of specialty/work
Street address
Nazmi martyr St. hundred machines left the last station
City
Gachsaran
Postal code
75818-16664
Phone
+98 74 2333 0254
Fax
Email
hosseinkavyani7@yahoo.com; h.kavyani@khuisf.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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