Evaluation of the effect of botulinum toxin A on preventing of abdominoplasty and mamoplasty surgery scar
Design
On twenty patients 2 weeks after operation Botox and normal saline will be injected at two different side of the scar. Clinical trial has control group in study phase 3
Settings and conduct
In Razi hospital injection will be done by dermatologist who doesn't know the kind of syringe ( Botox or normal saline)
Participants/Inclusion and exclusion criteria
Patients with mammoplasty and abdominoplasty scar, operated during past 10 days
Intervention groups
two weeks after surgery Botox will be injected at one side and normal saline at the other side
Main outcome variables
modified Stony Brook Scar Evaluation Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040876N1
Registration date:2018-12-01, 1397/09/10
Registration timing:registered_while_recruiting
Last update:2018-12-01, 1397/09/10
Update count:0
Registration date
2018-12-01, 1397/09/10
Registrant information
Name
Neda Mehdizade rayeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 3760
Email address
nedashervin95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of botolinum toxin A on preventing of abdominoplasty and mamoplasty surgery scar
Public title
Evaluation of botolinum toxin on preventing of scar
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mammoplasty and abdominoplasty scar, operated during past 10 days
Exclusion criteria:
Allergy to botox
Pregnancy and breastfeeding
History of radiotherapy and chemotherapy
Neuromotor diseases
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Injection in right or left side of the scar
Randomization (investigator's opinion)
Randomized
Randomization description
Right or left side of the scar will be injected randomly
Blinding (investigator's opinion)
Double blinded
Blinding description
Dermatologist who doesn't know syringe kind( Botox or normal saline) will inject it to the right or left
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Tehran University of Medical Sciences
Street address
Tehran university of medical sciences,ghods street,keshavarz bolvar
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.068
Health conditions studied
1
Description of health condition studied
scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
modified Stony Brook Scar Evaluation Scale
Timepoint
3&6 month after injection
Method of measurement
Including 4 factors: width, height, scar color and incision line. scoring is based on 0-8
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: two weeks after surgery Botox will be injected at one side and normal saline at the other side
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Neda mehdizade
Street address
razi hospital,vahdat eslami st,tehran
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0853
Email
razihospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohmad jafar sadigh damghani zade
Street address
16th Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 6111 3411
Email
Publicrel@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Neda mehdizade rayeni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
razi hospital,vahdat eslami st,tehran
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5562 0300
Email
nedashervin95@gamil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
neda mehdizade rayeni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
razi hospital,vahdat eslami st,tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0853
Email
nedashervin95@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda mehdizade rayeni
Position
Resient
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
razi hospital,vahdat eslami st,tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0853
Email
nedashervin95@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD