Evaluation of clinical outcomes and satisfaction of rhinoplasty with or without SMASectomy with the aim of thinning the nasal tip in patients with thick nasal skin
Double-blind, randomized clinical trial with a control group. A study on 70 patients who were randomly divided into two groups
Settings and conduct
Patients with thick skin in the nasal area after cosmetic surgery are not completely satisfied with the result of the operation, but with this method. This includes thinning the skin at the tip of the nose, which may improve patient satisfaction. The study is performed on patients in Isfahan hospitals. Patients are randomly divided into two groups, in one group the intervention and in the control group the intervention is not performed to thin the skin.
Participants/Inclusion and exclusion criteria
Admission requirements: Minimum age 18, Candidate for rhinoplasty surgery, Thick nasal skin, Informed consent. Exclusion criteria: history of rhinoplasty, history of smoking
Intervention groups
Patients in the control group are operated as usual ، and the intervention group is operated by removing adipose tissue and muscle behind the skin of the tip of the nose.
Main outcome variables
Variables include skin thickness, postoperative satisfaction, and complications such as bleeding, skin necrosis, edema, scarring, and postoperative infection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210921052537N1
Registration date:2021-10-30, 1400/08/08
Registration timing:prospective
Last update:2021-10-30, 1400/08/08
Update count:1
Registration date
2021-10-30, 1400/08/08
Registrant information
Name
Mehdi Rasti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8506
Email address
mh_rasti@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2021-12-01, 1400/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical outcomes and satisfaction of rhinoplasty with or without SMASectomy with the aim of thinning the nasal tip in patients with thick nasal skin
Public title
Evaluation of the effect of thinning of the tip of the nose on rhinoplasty in patients with thick skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who come for rhinoplasty
Patients have thick nasal skin
Patients are at least 18 years old
Patients who have given informed consent
Exclusion criteria:
Those who smoke
Those who have a history of rhinoplasty
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who go for rhinoplasty and have thick skin are divided into two groups by permuted block randomization method and the patient does not know the type of operation. After the operation, the result is examined by four groups, the beautician, the patient, the cosmetic nurse, and another plastic surgeon who does not know the type of operation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of esfahan University of Medical Sciences
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
A clinical trial report will be available for subscription, including gender, age, procedure, and postoperative information for each individual and postoperative outcome.
When the data will become available and for how long
Start access one year after the results are published
To whom data/document is available
Clinical study reports are only available to plastic surgeons
Under which criteria data/document could be used
Using reports from clinical studies to conduct research on rhinoplasty techniques can be used by citing the source.
From where data/document is obtainable
Esmaeil Talebian ,email: drtalebian@yahoo.com
What processes are involved for a request to access data/document
The applicant will receive a clinical study report after sending an email and explaining the reason for the need for the data, and future research of the applicant, after 10 days the information will be sent to him by email.