Evaluation of the effect of aloe vera cream on alar reconstruction scar after rhinoplasty
Design
In the first group, aloe vera cream will be used and in the second group, Face Dox cream will be used (repair cream with good performance and available in the market). Aloe vera cream will be prepared by a pharmacist. Patients will be in a double-blind study. In this way, the tubes of both creams are similar to each other in terms of color, smell and appearance of the contents inside the tubes, and the creams are marked with numbers A and B. alar surgery for rhinoplasty will be performed by an ENT specialist and the stitches will be removed a week later. At the same time, the creams will be started twice a day for a month.
Settings and conduct
alar surgery for rhinoplasty will be performed by an ENT specialist and the stitches will be removed a week later, at the same time the creams will be started twice a day for a month.Three months after surgery, the scar will be evaluated by the Manchester scar scale and dermoscopy and photography under the supervision of a dermatologist. The appearance of the wound and the wound erythema will be evaluated by the surgeon.
Study place: Shiraz Motahari ENT Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All men and women between the ages of 18 and 60 who have undergone rhinoplasty with alar removal
and wish to participate in this study
Exclusion criteria:
participants who have a underlying diseases
Intervention groups
In the first group, aloe vera cream will be used and in the second group, Face Dox cream will be used (repair cream with good performance and available in the market). Aloe vera cream will be prepared by a pharmacist. Patients will be in a double-blind study.
Main outcome variables
Scar status after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170704034897N3
Registration date:2022-03-05, 1400/12/14
Registration timing:prospective
Last update:2022-03-05, 1400/12/14
Update count:0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Seyed Hossein Owji
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 7985
Email address
owji_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effects of aloe vera cream and face doux on improving the appearance of scar after resection of ala in rhinoplasty
Public title
The effects of aloe vera cream and face doux on scar after rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All men and women between the ages of 18 and 60 who have undergone rhinoplasty with alar removal
and wish to participate in this study
Exclusion criteria:
participants who have a chronic obstructive pulmonary disease
participants who have uncontrolled heart diseases
participants who have heart failure
participants who have a hepatic and renal failure
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients into two treatment groups will be done based on the list obtained from the permuted block method. In this study, the number of blocks is 15 and the size of block is 4. A statistician generated the randomized list by using NCSS (statistical software).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this way, the tubes of both creams are similar to each other in terms of color, smell and appearance of the contents inside the tubes, and the creams are marked with numbers A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of medical sciences, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-07-24, 1400/05/02
Ethics committee reference number
IR.SUMS.MED.REC.1400.221
Health conditions studied
1
Description of health condition studied
wound scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Scar status after surgery
Timepoint
Three months after the initial surgery
Method of measurement
By Manchester scar scale and dermoscopy and photography under the supervision of a dermatologist and examination of the appearance of the wound and wound erythema by the surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, aloe vera cream will be used. Alar surgery in rhinoplasty will be performed by an ENT specialist and a week later the stitches will be removed and at the same time aloe vera cream will be applied to the wound twice a day for a month. The scar will be evaluated three months after scar surgery.
Category
Treatment - Drugs
2
Description
Control group: In this group, face doux cream (Wound healing cream with good performance and available in the market) will be used. Alar surgery in rhinoplasty will be performed by an ENT specialist and a week later the stitches will be removed and at the same time face doux cream will be applied to the wound twice a day for a month. The scar will be evaluated three months after scar surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari clinic at Shiraz University of Medical Sciences
Full name of responsible person
Seyed Hossein Owji
Street address
Khalili Hospital, Khalili street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3629 1470
Email
owji_h@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Shiraz University of medical sciences, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
memarpour@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Hossein Owji
Position
ENT resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Hossein Square- Medical School
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3212 2970
Fax
Email
owji_h@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Hossein Owji
Position
ENT resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Hossein Square- Medical School
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3212 2970
Fax
Email
owji_h@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Hossein Owji
Position
ENT resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Hossein Square- Medical School
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3212 2970
Fax
Email
owji_h@sums.ac.ir
Web page address
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