Investigating the effectiveness of botulinum toxin in preventing the creation of hypertrophic scars at the site of surgical wounds of the trunk, limbs and neck
Design
Non-randomized, single-blind, phase 2 clinical trial on 30 patients.
Settings and conduct
This study is a clinical trial that will be conducted on 30 patients who will undergo trunk, limb and neck surgeries at Sina Hospital in Tabriz. The scar site of the patients will be divided into two equal parts A and B. Part A will be the injection site of 0.1 ml tubulinum toxin and B will be the injection site of 0.9% normal saline. The site will be 1 cm away from the edges of the wound (5 units per point, with a distance of 1 cm). Follow-up of patients is scheduled at 3 months and 6 months after injection. To evaluate the scar, based on the Stony Brook Scar Evaluation Scales (SBSES) will be used to evaluate the width, height, color and location of the suture and the general view of the incision line.
Participants/Inclusion and exclusion criteria
This study will be conducted on 30 patients aged 18 to 80 who undergo trunk, limb and neck surgeries at Sina Hospital in Tabriz, with no history of sensitivity to botulinum and scars of at least 2 cm.
Intervention groups
Dyston brand botulinum toxin A (BTA) and normal saline 0.9% will be used as intervention, respectively. 0.1 ml of BTA will be injected at a site 1 cm away from the wound edges (5 units per site, spaced 1 cm apart) at site A. The same volume of normal saline 0.9% will be injected in the control side B with placebo.
Main outcome variables
adverse effects; clinical assessments; Scar evaluation based on Stony Brook scar evaluation scales
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100314003566N15
Registration date:2024-07-17, 1403/04/27
Registration timing:prospective
Last update:2024-07-17, 1403/04/27
Update count:0
Registration date
2024-07-17, 1403/04/27
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of botulinum toxin in preventing hypertrophic scarring at the site of surgical wounds on the trunk, limbs and neck
Public title
Evaluation of the effectiveness of botulinum toxin in preventing hypertrophic scarring
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 and 80 years of age with recent history of trunk, neck or extremity surgery in less than 10 days
Insensitivity to botulinum toxin
Consent to participate in the research project
Scar site with at least 2 cm
Exclusion criteria:
History of allergy to botulinum toxin
Pregnancy or breastfeeding
Recent botulinum injection within 6 months
History of radiotherapy and chemotherapy
History of wound healing disorder
History of recent surgery at the current site of surgery
Drug abuse
Any other cosmetic procedure at the surgical site, including laser or filler injection
Myasthenia gravis and other neuromuscular disorders
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The scar site of the patients will be divided into two equal parts A and B. In all patients with vertical scars, part A will be the top of the scar and part B will be the bottom of the scar. In horizontal scars, part A will be on the right side and part B will be on the left side of the scar. Part A will be the toxin injection site and B will be the control site.
Participants who received the injection were blinded to which treatment they received in the A and B areas of their scar site. Injections are performed at the same time and place by a dermatologist
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Approval date
2024-07-04, 1403/04/14
Ethics committee reference number
IR.TBZMED.REC.1403.241
Health conditions studied
1
Description of health condition studied
Hypertrophic scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Side effects
Timepoint
Before the intervention, 3 months after the intervention, 6 months after the intervention
Method of measurement
Clinical examinations
2
Description
Scar evaluation
Timepoint
Before the intervention, 3 months after the intervention, 6 months after the intervention
Method of measurement
Stony Brook Scar Evaluation Scales
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention: Botulinum toxin A (BTA) of Diston brand with a concentration of 0.1 ml of BTA will be injected at a site 1 cm away from the edges of the wound (5 units at each point, with a distance of 1 cm) at site A.
Category
Treatment - Drugs
2
Description
Control group: Placebo group: 0.1 ml of normal saline 0.9% will be injected in the controlled side B.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology cilinic of Sina hospital
Full name of responsible person
Dr. Azimi Dermatologist
Street address
sina hospital Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3541 2103
Email
azimi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Vice Chancellor for Research, Central Building of Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
51386631357
Phone
+98 41 3336 4667
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hamide Azimi
Position
Resident
Latest degree
Medical doctor
Street address
Tabriz University of Medical Sciences, Daneshgah ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
azimi@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamide Azimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Daneshgah ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
azimi@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamide Azimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Daneshgah ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
azimi@tbzmed.ac.ir
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
No - There is not 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
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
nyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The use request will be emailed to the scientific or public accountability person