Protocol summary

Study aim
Main goal of this study is to assess the efficacy of Epidermal Growth Factor on burn wounds grade II in comparison with standard treatment. The objectives are comparison of wound healing rate, evaluation of dermis and epidermis thickness to compare the quality of healing and comparison of wound dimensions after treatment.
Design
A clinical trial is performed with the control group, parallel groups, double-blind, randomized, on 35 patients with two samples (wounds on body parts).
Settings and conduct
Participants receive a package containing creams. They receive the same prescription for both creams.They will use cream with label number one for area one and cream with label number 2 for area 2. Both areas are cleansed every 12 hours with normal saline, the control area is treated with topical silver sulfadiazine cream and is covered with sterile gauze. For the intervention group, 1% silver sulfadiazine topical cream containing epidermal growth factor is used and is covered with sterile gas.
Participants/Inclusion and exclusion criteria
Admission requirements: Age 18-60 years; second-degree burns, bilateral, on both hands or feet, etc.; willingness to participate in the study. Exclusion criteria: Any underlying diseases that interfere with wound healing, such as chronic kidney disease, diabetes, liver disease, and any immunodeficiency disease or smoking; having any type of cancer or history of cancer; any allergy to recombinant epidermal growth factor, silver sulfadiazine or any substance in the formulation.
Intervention groups
Two burn areas per person are randomly assigned to zones 1 or 2, and each area will receive one treatment (silver sulfadiazine cream for the control area and silver sulfadiazine cream containing EGF for the intervention area).
Main outcome variables
Wound size; Epidermis thickness; Dermis thickness; Speed ​​of wound healing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220424054633N1
Registration date: 2022-06-06, 1401/03/16
Registration timing: prospective

Last update: 2022-06-06, 1401/03/16
Update count: 0
Registration date
2022-06-06, 1401/03/16
Registrant information
Name
Majid Golkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 627 5629
Email address
majid.golkar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-10, 1401/03/20
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
‍Comparison of efficacy of Silversulfadiazine topical cream containing Epidermal growth factor (EGF) and Silversulfadiazine topical cream without Epidermal growth factor (EGF) on burn wounds healing (type II).
Public title
The efficacy assessment of Silversulfadiazine topical cream containing Epidermal growth factor (EGF) on burn wounds healing (type II)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with grade II burn wounds. Burn area must be bilateral, in 2 hands or 2 legs, etc.
Exclusion criteria:
Having any underlying diseases that interfere with wound healing such as chronic kidney disease, diabetes, liver disease, any diseases of immunodeficiency, and smoking. Having cancer or background of Cancer Allergy to Epidermal Growth Factor, silver sulfadiazin or any material in the formulation. Pregnancy Breastfeeding
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 35
More than 1 sample in each individual
Number of samples in each individual: 2
Participants have bilateral grade II burns. One area will be chosen randomly as control area and one area as the intervention.
Randomization (investigator's opinion)
Randomized
Randomization description
Two areas of each participant's burn site are randomly assigned as area one and area two. Since the study is double blind the physician chooses the burn areas by simple randomization.The creams of the intervention group and the control group are prepared by one of the project partners for each person and are given to the patient as one and two, to use cream one in area one and cream two in area two.
Blinding (investigator's opinion)
Double blinded
Blinding description
The coding is done by the project epidemiologist. The doctor receives the creams labeled with numbers 1 or 2, and by simple randomization, considers one area as area one, and prescribes cream number one, and considers the other area as area number 2 and prescribes cream number two. The doctor gives the patient additional information on how to use the creams. The patient also receives labeled creams that are similar in color and texture. The method of using both creams is the same, only for area one, cream number one and for area number 2, cream number 2 is used. The evaluator who evaluates the burn site at the beginning of the study and then at the end of the first, second, third and fourth weeks and collects the data also is not aware of coding system. The doctor, the evaluator and the patient are blind. The patient receives the coded drug (intervention or control). The data analyzer who drafts the article knows is aware of the coding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Tehran University of Medical Sciences
Street address
Research ethics committees of school of medicine- Tehran university of medical sciences. Qods street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1510

Health conditions studied

1

Description of health condition studied
Grade II burn wounds
ICD-10 code
T29.2
ICD-10 code description
Burns of multiple regions, no more than second-degree burns mentioned

Primary outcomes

1

Description
Wound size
Timepoint
At the beginning of the study (Before intervention), end of first week, end of second week, end of third week, end of fourth week.
Method of measurement
Photography and Image J software

2

Description
Epidermis Thickness
Timepoint
At the beginning of the study (Before intervention), end of first week, end of second week, end of third week, end of fourth week.
Method of measurement
Biometry

3

Description
Dermis Thickness
Timepoint
At the beginning of the study (Before intervention), end of the first week, end of the second week, end of the third week, end of the fourth week.
Method of measurement
Biometry

4

Description
wound healing velocity
Timepoint
At the beginning of the study (Before intervention), end of the first week, end of the second week, end of the third week, end of the fourth week.
Method of measurement
Photography and Image J software

Secondary outcomes

1

Description
Improving Life's Quality
Timepoint
َAt the beginning of the study and two week after finishing the study.
Method of measurement
Interviewing and giving out self assessment form

Intervention groups

1

Description
Intervention group: Silver Sulfadiazine 1% containing 0.001% Epidermal Growth Factor topical cream was used and the burn wound area is covered by sterile gauze, very 12 hours wound area is cleaned by normal saline and bandaged.
Category
Treatment - Drugs

2

Description
Control group: Silver Sulfadiazine 1% topical cream was used and the burn wound area is covered by sterile gauze, every 12 hours wound area is cleaned by normal saline and bandaged. In fact the control group receives the standard treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Hospital
Full name of responsible person
Majid Golkar
Street address
Shahid Motahari Hospital, Shahid Rashid Yasemi, Valiasr Ave. St.,
City
Tehran
Province
Tehran
Postal code
1234567891
Phone
+98 21 8877 0031
Email
majid.golkar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
Skin and stemcell research center, No.4, Maryam deadend, South Kamraniey
City
Tehran
Province
Tehran
Postal code
1234567895
Phone
+98 21 2665 7541
Fax
+98 21 2223 9264
Email
info@skinstemce
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
50
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

2

Sponsor
Name of organization / entity
Borna Biopharma Science based Co.
Full name of responsible person
Samira Amiri
Street address
No. 1246, Tehran University Incubator of Pharmaceutical units , End of North Kargar St., Above Jalal Al-Ahmad, next to Tehran university dormitory, opposite of the Faculty of Physical Education, Tehran.
City
tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8603 5420
Email
samiraamiri.86@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Borna Biopharma Science based Co.
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Pasture Institute of Iran
Full name of responsible person
Majid Golkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 69, Pasteur St., Tehran
City
Tehran
Province
Tehran
Postal code
1316943551
Phone
+98 21 6411 2267
Email
majid.golkar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pasture Institute of Iran
Full name of responsible person
Majid Golkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Np.69, Pasteur St. Tehran
City
Tehran
Province
Tehran
Postal code
1316943551
Phone
+98 21 6411 2267
Email
majid.golkar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Amiri
Position
project partner
Latest degree
Master
Other areas of specialty/work
Medical Biotechnology
Street address
Keshavarz Blvd., Qods St.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8603 5420
Email
samiraamiri.86@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
Privacy control
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
No - There is not 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 Protocol, clinical trial report, codes used in the analysis, study dictionary
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Public
Under which criteria data/document could be used
Sending an email to the person in charge of updating the results
From where data/document is obtainable
Sending an email to the person in charge of updating the results
What processes are involved for a request to access data/document
Receiving request email by the responsible person, assessing the request and sending the required data
Comments
Loading...