Protocol summary

Study aim
This study is performed to evaluate the effect of local, inexpensive, standard and effective ZOUSH drug on the healing of second degree burn wounds through macroscopic and microscopic examination (histopathological) of the samples and to investigate the changes in the expression level of genes involved in this repair.
Design
Clinical trials are conducted in parallel, In this study, the case and control are both the same patient.The study is a one-way blind and phase 3 and is randomized in the sampling area. Excel function rand function is used for randomization.
Settings and conduct
This study is performed in Shahid Motahari Hospital. Sampling of each patient in the burn area is done before and after treatment. In this study, the patient, pathologist and geneticist were blinded. The patient is unaware of the type of treatment in the treated areas and the pathologist and geneticist have been blinded to the type of sample received.
Participants/Inclusion and exclusion criteria
Inclusion criteria:the presence of second degree burns in the patient referred to Shahid Motahari Hospital;their willingness to participate in the study;complete the informed consent form. Exclusion criteria:patients' unwillingness to participate in the study;the presence of first or third degree burns, a history of trauma or previous burns in the burned area;facial burns, which are aesthetically important.
Intervention groups
In this study, 20 patients are sampled in three areas. Due to pre-treatment sampling, after treatment in the ZOUSH-treated area and in the amniotic-treated area, each patient can be considered as a control for himself.
Main outcome variables
One of the goals of the Trauma Research Center is to find new and local treatments for burn trauma. In this project, a cheap and effective local medicine for the treatment of burn wounds will be genetically and histopathologically examined.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200731048258N1
Registration date: 2020-10-22, 1399/08/01
Registration timing: registered_while_recruiting

Last update: 2020-10-22, 1399/08/01
Update count: 0
Registration date
2020-10-22, 1399/08/01
Registrant information
Name
Mohammad Soleymani Farsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6614 5482
Email address
soleymani.mm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of ZOUSH in second degree burn wound healing in terms of histopathology and changes in the expression of some genes involved in wound healing process
Public title
Evaluation of the effectiveness of ZOUSH in burn wound healling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
second degree burn wound
Exclusion criteria:
Burn wounds in aesthetically sensitive areas A history of previous trauma or burns to the burned area Patients' reluctance
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 3
A 3mm tissue sample is taken from the burn patient's skin before treatment. a 3mm tissue sample will be taken in the area treated with ZOUSH and another 3mm tissue sample in the area of the amniotic dressing after treatment.
Randomization (investigator's opinion)
Randomized
Randomization description
A small portion of the patient's wound is randomly selected and treated with ZOUSH. The rest of the wound is treated with standard amniotic dressing. By accident, here means that the burn is not intended for a specific area of the body. In addition, a special part of the burned area is not considered. If there is a random burn in each organ, a part of it will be selected for treatment with ZOUSH.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, pathologist, and genetic researcher are completely unaware of which area is receiving standard amniotic fluid treatment and which area is being treated with ZOUSH, and data analysis is performed by blinding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
No. 9, Majd Alley, North Kargar Street, Enghelab Square, Tehran
City
Tehran
Province
Tehran
Postal code
1418945398
Approval date
2020-06-08, 1399/03/19
Ethics committee reference number
IR.BMSU.REC.1399.217

Health conditions studied

1

Description of health condition studied
Second degree burn wounds
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effect of ZOUSH ointment on the healing of second degree burn wounds
Timepoint
Evaluation of genetic and histopathological changes before and after treatment with ZOUSH and standard amniotic dressing
Method of measurement
3 mm skin punch

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Part of the burn patient's skin is treated with ZOUSH ointment. This ointment contains Satureja khuzestaniea, Zataria multiflora and MenthaMozaffariani Jamzad with Honey, and Polyurethane. Used once on the burn and after seven days the effectiveness of the drug will be evaluated.
Category
Treatment - Drugs

2

Description
Intervention group: Part of the patient's skin is treated with a standard amniotic dressing. Sampling of this part is done on the seventh day after treatment to evaluate the effectiveness of treatment.
Category
Treatment - Drugs

3

Description
Control group: A portion of the patient's skin is biopsied and studied as a control before starting treatment. In this study, the case and control is the patient and its different parts of the skin before and after the treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid-Motahari-Hospital
Full name of responsible person
محمد سلیمانی فارسانی
Street address
No. 9, Majd Alley, North Kargar Street, Enghelab Square.
City
Tehran
Province
Tehran
Postal code
1418945398
Phone
+98 21 6657 0590
Email
soleymani.mm@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
محمد سلیمانی فارسانی
Street address
North kargar
City
Tehran
Province
Tehran
Postal code
1418945398
Phone
+98 21 6657 0590
Email
soleymani.mm@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
mohammad soleimani farsani
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1418945398
Phone
+98 21 6657 0590
Email
soleymani.mm@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
محمد سلیمانی فارسانی
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1418945398
Phone
+98 21 6657 0590
Email
soleymani.mm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
mohamad soleimani farsani
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No9, Majd alley, North Kargar Ave, Enghelab square
City
Tehran
Province
Tehran
Postal code
8945398141
Phone
+98 21 6657 0590
Email
soleymani.mm@gmail.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not 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
At the end of the study, the results of the research will be publish as an article.
When the data will become available and for how long
data will be available endless.
To whom data/document is available
all people.
Under which criteria data/document could be used
in order to extend information in the fields of burn patients treatment the results will be available without limitations.
From where data/document is obtainable
paper publisher site.
What processes are involved for a request to access data/document
one month later the request will be answered by the email.
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