Accelerating the healing of these injuries will reduce significant hospital costs and patient expenses, and will result in better aesthetic outcomes. The purpose of this study is to examine the effects of aloe vera on speeding up the healing of skin grafts and its impact on aesthetic results.
Design
The present study is a randomized clinical trial. In this study, all participants will enter the study after meeting the inclusion criteria and giving informed consent. Participants will be allocated to two groups, A (intervention) and B (control), in a random sequence that will be generated beforehand, which is unpredictable and completely random. Random block randomization with blocks of 8 will be used for allocating the samples.
Settings and conduct
The present study is a randomized clinical trial. Patient recruitment and grouping are done under the supervision of the treating physician. There is no blinding and evaluation is done based on the Oscar and Vancouver scale.
Participants/Inclusion and exclusion criteria
Have second or third degree burns.
Not have any underlying conditions and should not be taking any specific medications.
If they are not satisfied with the treatment process, they should withdraw from the intervention.
The average age range of the participants is 7 to 60 years old.
Both men and women participate in the experiment.
Intervention groups
Treatment in the control group: After the procedure, Oserin ointment is applied to the wound by rubbing.
Treatment in the intervention group: After the procedure, Oserin ointment containing aloe vera gel is applied to the wound by rubbing.
Main outcome variables
Pain
Scar
Recovery time
Body part
Age
Gender
Initial scar area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201006048950N5
Registration date:2024-03-27, 1403/01/08
Registration timing:prospective
Last update:2024-03-27, 1403/01/08
Update count:0
Registration date
2024-03-27, 1403/01/08
Registrant information
Name
Mahboobeh Khosravani
Name of organization / entity
Arakuniversity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
mahboobkhosravani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aloe vera plant Ointment on the healing process of skin grafts
Public title
Investigating the effect of aloe vera plant Ointment on the healing process of skin grafts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Second and third degree burns.
Do not have any underlying medical conditions and do not be taking any specific medication.
In case of not been satisfied with the treatment process, they can withdraw from the intervention.
The average age of the participants in the group is between 7 and 60 years old.
Both genders, male and female, participate in the experiment.
Exclusion criteria:
Age
From 7 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to two groups, A (intervention) and B (control), in order of entry and based on a randomly generated randomization sequence that will be produced in advance. This sequence is unpredictable and its arrangement is completely random. A block randomization method with blocks of 8 will be used for assigning samples. Therefore, using software to generate random numbers in a block and Randomization sequence proportional to the required sample size for the two groups will be produced. Initially, all possible cases where two letters A and B can be placed next to each other in a block of 4 will be generated, and then randomly and by selecting a block among the blocks, the pattern of arrangement in that block will be used for assigning participants. Then this block will be placed in the main container and another block will be selected. All of these actions will be performed using software called sealed envelope. This method also ensures concealment. The concept of concealment is the unpredictability of assigning individuals to groups. In fact, the researcher will not be able to predict which group the next person is supposed to be in.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University of Medical Sciences
Street address
Adli Alley, Meysam St., Abbas Abad St., Arak City
City
Arak
Province
Markazi
Postal code
3813734197
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.ARAKMU.REC.1402.228
Health conditions studied
1
Description of health condition studied
Second and third degree burns
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of Aloe vera ointment on the process of healing skin grafts
Timepoint
One and Six months after surgery, the area will be evaluated.
Method of measurement
According to Vancouver Scar Scale (VSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After applying the Ousarin ointment procedure, the gel containing aloe vera is massaged onto the wound.
Category
Treatment - Drugs
2
Description
Control group: After performing the procedure, the ointment Eucerin is applied to the wound by massaging.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr hospital
Full name of responsible person
Masoumeh Heydari Bateni
Street address
Imam Khomeini Street, Vali Asr Square, Arak, Central Province
City
Arak
Province
Markazi
Postal code
7558538149
Phone
+98 86 3222 2003
Email
arak@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Khosravani
Street address
Basij square, sardasht street, medical university of arak, faculth of nursing
City
Arak
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3505
Email
mahboobkhosravani@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Khosravani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij square, sardasht street, medical university of arak, faculth of nursing
City
Markazi
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
mahboobkhosravani@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Khosravani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij square, sardasht street, medical university of arak, faculth of nursing
City
Markazi
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
mahboobkhosravani@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Khosravani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij square, sardasht street, medical university of arak, faculth of nursing
City
Markazi
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
mahboobkhosravani@arakmu.ac.ir
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