Treatment effects and possible side effects of nano-fat injection in improvement of atrophic scars due to cutaneous leishmaniasis
Design
Clinical trial without control group, Blinding and randomization have not been done on 14 patient
Settings and conduct
This study will be conducted on 14 patients with facial leishmaniasis scar who will be visiting dermatology clinic in imam reza hospital
at first fat will be harvested then via sedimentation method blood and tumesent fluid will be separated from fat, and at last the final product will be injected intradermally using a 1 cc syringe with a 1 cm space between each injection site
Patient assessment recovery will be preformed 6 months later
Participants/Inclusion and exclusion criteria
Patients over 18 years of age with leishmaniasis scars on the face; At least two years since the active leishmaniasis infection recovered; Patient consent
Exclusion criteria: Under 18 and over 50 years of age; Mental Illness
Bleeding disorders or usage of anticoagulants; Pregnancy and Lactation
Intervention groups
consent will be obtained from patients more than 18 years of age with leishmaniasis facial scar before entering the study
Technique: First Fat will be harvested, Then, will be separated from the blood and tumescent solution by sedimentation method, after that nano-fat will be prepared by emulsifying the fat via 2.4, 1.4 and 1.1 size connectors then the final product will be transferred to 1 cc syringes and injected with 30 gauge needles intradermal and at intervals of 1 cm.
Main outcome variables
Change in scar intensity based on it color, depth and consistency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200526047577N1
Registration date:2022-02-14, 1400/11/25
Registration timing:registered_while_recruiting
Last update:2022-02-14, 1400/11/25
Update count:0
Registration date
2022-02-14, 1400/11/25
Registrant information
Name
Mohammed Tehami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3838 3903
Email address
mohd.tehami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-30, 1400/10/09
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of mechanical nanofat injection method in improvement of atrophic scar of cutaneous leishmaniasis in Khorasan Razavi
Public title
Effect of fat injection in improvement of atrophic scar of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Atrophic scars due to Leshminiasis
Did not seek treatment for the last 6 months
Facial scar
Leishmaniasis infection improvement for at least two years
Exclusion criteria:
Patients with Bleeding disorders
Patient who did not fill a consent form
Patient with comorbidities e.g. Diabetes Mellitus, Hyper tension or autoimmune disorders
Pregnancy and breastfeeding
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Scineces (Ghorashi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2021-12-04, 1400/09/13
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.585
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis scar
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Change in scar intensity based on it color and depth and consistency
Timepoint
6 months
Method of measurement
The patient and observer scar assessment scale (POSAS) and Photographs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients over 18 years of age with leishmaniasis scars on the face
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic, Imam Reza a. Hospital
Full name of responsible person
Mohammed Tehami
Street address
Ibin sina street, Imam Reza a Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2031
Email
mohd.tehami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majeed Ghaior
Street address
Central Building of Mashhad University of Medical Scineces (Ghorashi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammed Tehami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Ibin sina street, Imam Reza a Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 2031
Email
mohd.tehami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vahid Mashayekhi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Ibin sina street, Imam Reza a Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2031
Email
mashayekhv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammed Tehami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Ibin sina street, Imam Reza a Hospita
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 2031
Email
mohd.tehami@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patient are made unidentified.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.