Comparison of the effects of triamcinolone and bleomycin on hypertrophic scars caused by body burns
Design
This study is a clinical trial with a control group, with parallel groups, double-blind, randomized on 35 patients. Block randomization method was used for randomization.
Settings and conduct
For each patient, two adjacent or non-adjacent areas in the body are randomly selected for intralesional injection (triamcinolone and bleomycin). The selected burn size is between 5 and 10 square centimeters. The injection site for triamcinolone and bleomycin is clearly defined so that they are not confused in future injections. The maximum dose of triamcinolone is 40 mg per course and the maximum dose of bleomycin is 10 units. The injection is performed using a #27 needle under sedation in the operating room.
At the beginning of the study and at the end of the fourth month, quality photos are taken of all patients with a camera to be compared by two plastic surgeons.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Burn patients two months after recovery
Exclusion criteria: Patient dissatisfaction, Hypersensitivity to triamcinolone or bleomycin
Intervention groups
Intervention group: The effect of bleomycin drug on the healing of hypertrophic scars caused by burns.
Control group: The effect of triamcinolone drug on the healing of hypertrophic scars caused by burns.
Main outcome variables
Scar size, injection site pain, injection site inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120410009431N4
Registration date:2022-11-21, 1401/08/30
Registration timing:prospective
Last update:2022-11-21, 1401/08/30
Update count:0
Registration date
2022-11-21, 1401/08/30
Registrant information
Name
Siamak Farokh Forghani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 2974
Email address
siamakfarokh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of triamcinolone and bleomycin on hypertrophic scars caused by body burns
Public title
Comparison of the effects of triamcinolone and bleomycin on burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Burn patients two months after recovery
Exclusion criteria:
Patient dissatisfaction
Hypersensitivity to triamcinolone or bleomycin
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.
To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit.
Here, based on the block 4, we divide patients into groups.
1. TTCC 2. TCTC 3. TCCT
4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups 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 Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8874113911
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.IUMS.FMD.REC.1399.061
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
M61.3
ICD-10 code description
Calcification and ossification of muscles associated with burns
Primary outcomes
1
Description
Scar size
Timepoint
Four months after injection
Method of measurement
Using a ruler
2
Description
Pain in the injection area
Timepoint
After injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
injection site inflammation
Timepoint
After injection
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: For each patient, two adjacent or non-adjacent areas in the body are randomly selected for intralesional injection (triamcinolone). The selected burn size is between 5 and 10 square centimeters. The injection site for triamcinolone is clearly defined so that they are not confused in future injections. The maximum dose of triamcinolone (manufactured by Exir company) is 40 mg per period. The injection is performed using a #27 needle under sedation in the operating room. All patients will be taken quality pictures with a camera at the beginning of the study and at the end of the fourth month to be compared by two plastic surgeons.
Category
Treatment - Drugs
2
Description
Control group:For each patient, two adjacent or non-adjacent areas in the body are randomly selected for intralesional injection (bleomycin). The selected burn size is between 5 and 10 square centimeters. The injection site for bleomycin is clearly defined so that they are not confused in future injections. The maximum dose of bleomycin (manufactured by Exir company) is 10 units per period. The injection is performed using a #27 needle under sedation in the operating room. All patients will be taken quality pictures with a camera at the beginning of the study and at the end of the fourth month to be compared by two plastic surgeons.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate fatemeh hospital
Full name of responsible person
Siamak Farokh Forghani
Street address
16 Azar street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 2220 2974
Email
siamakfarokh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8670 5503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Siamak Farokh Forghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
16 Azar street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8670 5503
Email
siamakfarokh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Siamak Farokh Forghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
16 Azar street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8670 5503
Email
siamakfarokh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Siamak Farokh Forghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
16 Azar street, Keshavarz avenue
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 2220 2974
Email
siamakfarokh@yahoo.com
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