A comparison study of the effect of intralesional injection of botulinum toxin type A with triamcinolone acetonide in the treatment of pruritus after burns in Taleghani Hospital, Ahvaz in 1403
Effect of intralesional injection of botulinum toxin type A with triamcinolone in the treatment of pruritus after burns
Design
Parallel group, single-blind, clinical trial
Settings and conduct
In Taleghani Hospital in Ahvaz, burn patients were divided into two groups. Triamcinolone was injected for itch control in the control group, and botulinum toxin was injected for intervention group.
Participants/Inclusion and exclusion criteria
Burn patients; Pregnant and breastfeeding woman, Being allergic to botulinum toxin type A, immune deticiency, neuromuscular disease such as MS and MG.
Intervention groups
Injection of botulinum type A to the burn lesion
Main outcome variables
The level of itching, age, gender, depth of burn, location of burn.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240418061517N1
Registration date:2024-07-17, 1403/04/27
Registration timing:retrospective
Last update:2024-07-17, 1403/04/27
Update count:0
Registration date
2024-07-17, 1403/04/27
Registrant information
Name
Shahram Goudarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8627
Email address
farkhondehpourali@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-26, 1403/01/07
Expected recruitment end date
2024-04-24, 1403/02/05
Actual recruitment start date
2024-03-26, 1403/01/07
Actual recruitment end date
2024-04-24, 1403/02/05
Trial completion date
2024-09-05, 1403/06/15
Scientific title
A comparison study of the effect of intralesional injection of botulinum toxin type A with triamcinolone acetonide in the treatment of pruritus after burns in Taleghani Hospital, Ahvaz in 1403
Public title
"Effect of intralesional injection of botulinum toxin type A with triamcinolone in the treatment of pruritus after burns”
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Burn
Exclusion criteria:
Pregnant and breastfeeding woman
Being allergic to botulinum toxin type A
Weak immune system
Neuromuscular disorders such as MS and myasthenia gravis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In each patient, the area with the most itching due to the burn is selected. This area is divided into two equal parts, with botulinum toxin type A injected into one part and triamcinolone acetonide injected into the other. These areas are recorded on a chart known to the physician, but the patient has no informtion about which drug is injected into which part.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jondishpur Univercity of Medical Science
Street address
Golestan Highway, Jondishpur Univercity of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
IR.AJUMS.REC.1402.619
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T31
ICD-10 code description
Burns classified according to extent of body surface involved
Primary outcomes
1
Description
Amount of botolinum toxin
Timepoint
After one month
Method of measurement
Unit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving botulinum toxin type A from the manufacturer”Maspore” at the dose of 500 units, diluted with 2 ml of saline per vial, resulting in 25 units of botulinum toxin type A per 0.1 ml injected intralesionally.
Category
Treatment - Drugs
2
Description
Control group: receiving an ampoule of triamcinolone acetonide at a concentration of 10 mg/ml, injected to achieve blanching of the site. Patients are followed up for 6 months and their itching severity is assessed during visits.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Hosseininejad
Street address
Hejrat Blvd, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6186795438
Phone
+98 61 3943 3311
Email
farkhondeh.prl@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Hosseininejad
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 61 3943 3311
Email
farkhondeh.prl@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Goudarzi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hejrat Blvd, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6187943867
Phone
+98 61 3943 3311
Email
farkhondeh.prl@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Goudarzi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hejrat Blvd, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6187543867
Phone
+98 61 3984 3311
Email
farkhondeh.prl@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Goudarzi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hejrat Blvd, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6187543867
Phone
+98 61 3984 3311
Email
farkhondeh.prl@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information can be shared.
When the data will become available and for how long
Four month after publication.
To whom data/document is available
Everyone
Under which criteria data/document could be used
Treatment of burn patients.
From where data/document is obtainable
My Email address
What processes are involved for a request to access data/document