Determination the Effect of Calcium Alginate Silver tampon on bleeding after Rhinoplasty
Design
The clinical trial is performed on 30 patients and 60 samples and do not have exclusion criteria. Nasal holes are randomly considered as both intervention and control groups.
Settings and conduct
The place of rhinoplasty is in Omid Hospital.The dressing of alginate calcium silver wich is randomly placed in one of the nostrils after rhinoplasty and Gentamicin ointment dressing that is applied after surgery in the other nostril , Then ; Both groups after rhinoplasty surgery are examined for bleeding and pain during remove the dressing
Participants/Inclusion and exclusion criteria
Entry Requirements; All individuals have a rhinoplasty surgen indication. Conditions of inactivity ; Patients who are Sensitive are Calcium Alginate with Silver and Patients with anatomical anomalies and asymmetry of the nasal cavity
Intervention groups
Intervention group ; The dressing of alginate calcium silver wich is randomly placed in one of the nostrils after rhinoplasty. Control group ; Gentamicin ointment dressing that is applied after surgery in the other nostril
Main outcome variables
In this study, The variables ; The amount of bleeding , and pain during dressing in measured .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037893N2
Registration date:2018-05-09, 1397/02/19
Registration timing:retrospective
Last update:2018-05-09, 1397/02/19
Update count:0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Hamidreza Mahaseni aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 6440
Email address
h_mahaseni@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-13, 1396/11/24
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion effect of nasal tampon calcium alginate with silver and sterilized gas with gentamicin ointment on bleeding after surgery of rhinoplasty
Public title
Comparsion effect of nasal tampon calcium alginate with silver and sterilized gas with gentamicin ointment on bleeding after surgery of rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All individuals have a rhinoplasty surgen indication
Exclusion criteria:
Patients sensitive to calcium alginate silver
Patients with anatomical abnormalities and nasal cavity asymmetry
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Nasal holes are randomly considered as both intervention and control groups
Randomization (investigator's opinion)
Randomized
Randomization description
Nasal holes are randomly considered as both intervention and control groups.Simple random individually with using random numbers
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
Ethics Committee Of Islamic Azad University Of Medical Sciences
Street address
No. 4, 10th Neyestan., Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19486
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,17
Health conditions studied
1
Description of health condition studied
deformity of nose
ICD-10 code
M95.0
ICD-10 code description
Acquired deformity of nose
Primary outcomes
1
Description
The amount of bleeding
Timepoint
1,6,and 24 hours after intervene
Method of measurement
Based on the weight of the gases used and measured miligram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The dressing of alginate calcium silver wich is randomly placed in one of the nostrils after rhinoplasty
Category
Treatment - Drugs
2
Description
Control group: Gentamicin ointment dressing that is applied after surgery in the other nostril