Protocol summary

Study aim
Comparison of the effect of Swalin ointment and 1 Silver sulfadiazine on the repair of 2nd degree deep burns
Design
A randomized, single-blind, interventional, control group clinical trial, phase 3 on 82 patients. The randomization tool of this study is Excel software and this software is also used to create a random sequence.
Settings and conduct
Patients with deep 2nd degree burns who refer to Shahid Motahari Burn Hospital in Tehran during the study, if they are eligible, will be included in the study and will be randomly assigned to the intervention and control groups using the random block method. This study will be conducted in a double-blind manner, so that the patients and the doctor examining the patients will not know the type of intervention.
Participants/Inclusion and exclusion criteria
Age 15-45 years, deep 2nd degree thermal burn wound of the body less than 10% in total, good general condition and no underlying disease such as diabetes, no history of autoimmune diseases, no HIV infection, no history of taking immunosuppressive drugs, No history of immune system deficiency, no history of hospitalization in the psychiatric ward, no history of burns. Conditions for not entering the study:other types of burns such as chemical, electrical, etc., wound stained with polluting substances, use of any substance other than drinking water on the wound before entering the study, untreated active infection in different parts body, patients with underlying diseases and immune system defects such as cancer, AIDS, diabetes, high blood pressure, etc., burns on the face and genital areas, pregnant and lactating women.
Intervention groups
In the first group of patients with deep 2nd degree burns and treated with 1% silver sulfadiazine ointment, and in the second group of patients with deep 2nd degree burns and treated with Swalin ointment.
Main outcome variables
The size of the burn surface

General information

Reason for update
Acronym
Swalin (SW) Silver Sulfadiazine (SSD)
IRCT registration information
IRCT registration number: IRCT20220702055349N1
Registration date: 2022-11-05, 1401/08/14
Registration timing: prospective

Last update: 2022-11-05, 1401/08/14
Update count: 0
Registration date
2022-11-05, 1401/08/14
Registrant information
Name
Mehrdad Bakhtiyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2689
Email address
mehr_bakhtiyari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Swalin ointment and 1% Silver sulfadiazine on the repair of 2nd degree deep burns
Public title
Comparison of the effect of Swalin ointment and 1% silver sulfadiazine on deep 2nd degree burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15-45 years, 2nd degree thermal burn wound of 1% to 2% depth of the body, less than 24 hours have passed since the burn, good general condition and no pregnancy, no underlying disease such as diabetes, no history of autoimmune diseases, No HIV infection, no immune system deficiency, no history of taking immunosuppressant drugs, no history of psychiatric disorders, no history of electrical chemical thermal burns, no history of allergies and sensitivities.
Exclusion criteria:
Other types of burns, such as chemical, electrical, etc., wound stained with polluting substances, using any substance other than drinking water on the wound before entering the study, untreated active infection in different parts of the body, patients with underlying diseases and immune system defects such as cancer, AIDS, diabetes, high blood pressure, etc., burns on the face and genital areas, pregnant and lactating women,
Age
From 15 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study is done through block randomization with 6 blocks. The randomization unit is an individual type. The randomization tool of this study is Excel software and this software is also used to create a random sequence. For concealment, an experienced person who is not one of the project collaborators, in a separate center after registering the participants' information, defines the ointment code separately for each patient and informs the research team about the corresponding code.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher, doctor and data analyst, who is responsible for collecting information, do not know the type of drug used, all patients are fully informed about the type of ointment used, and a written consent form is completed for each of them, and all treatment steps are also It will be under the supervision of the center's specialist doctor.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-10-15, 1401/07/23
Ethics committee reference number
IR.IUMS.FMD.REC.1401.373

Health conditions studied

1

Description of health condition studied
Burns
ICD-10 code
T22
ICD-10 code description
Burn and corrosion of shoulder and upper limb, except wrist and hand

2

Description of health condition studied
Burns
ICD-10 code
T23
ICD-10 code description
Burn and corrosion of wrist and hand

3

Description of health condition studied
Burns
ICD-10 code
T24
ICD-10 code description
Burn and corrosion of lower limb, except ankle and foot

4

Description of health condition studied
Burn
ICD-10 code
T25
ICD-10 code description
Burn and corrosion of ankle and foot

Primary outcomes

1

Description
The size of the burn surface
Timepoint
Days 1, 7, 14, 21 and 28
Method of measurement
Photo image using imageJ software

Secondary outcomes

1

Description
Angiogenesis factors
Timepoint
fourteenth day
Method of measurement
ELISA assay

2

Description
Inflammatory factors
Timepoint
Days 3, 7 and 14
Method of measurement
ELISA assay

3

Description
The amount of collagen
Timepoint
fourteenth day
Method of measurement
Masson's Trichrome Stain

4

Description
Number of vascular sections
Timepoint
fourteenth day
Method of measurement
H&E Staining

5

Description
Epithelialization
Timepoint
fourteenth day
Method of measurement
H&E Staining

Intervention groups

1

Description
Intervention group:Patients with deep 2nd degree burns and treated with Swalin ointment
Category
Treatment - Drugs

2

Description
Control group: Patients with deep 2nd degree burns and treated with 1% silver sulfadiazine ointment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Burns Hospital of Tehran
Full name of responsible person
Mehrdad Bakhtiyari
Street address
Shahid Motahhari Burn Hospital, Rashid-Yasemi Ave, Valieasr Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۴۳۵۳
Phone
+98 21 8877 0031
Email
hospital.motahari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Bakhtiyari
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1021
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Bakhtiyari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2689
Email
mehr_bakhtiyari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamidreza Alizadeotaghvar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic & Reconstructive Surgery
Street address
Shahid Motahhari Burn Hospital, Rashid-Yasemi Ave, Valieasr Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۴۳۵۳
Phone
021-88770031-36
Email
drhralizade@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahdi Heydari
Position
Student
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2689
Email
Mahdiheydari438@yahoo.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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