Protocol summary
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Study aim
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Comparison of the percentage of reduction of burn surface area, disappearance of irritation and pain on 3rd, 5th, 7th and 15th day after initiation of treatment with green tea extract cream in intervention group and control silver sulfadiazine cream treated group
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Design
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This is a double blind parallel clinical trial in which the physicians, the nurses and patients are unaware of the given treatment.
The patients will be randomly allocated in two parallel groups with 25 patients in each one. Randomized allocation will be based on computer-generated number.
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Settings and conduct
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Taleghani Burn Hospital is the place for conducting the research project.
Protocol: In the intervention group the burn area will be washed with sterile normal saline and a layer of polyphenol green tea cream will be applied and dressing with sterilized gauze and bandage.
In the control group: The burn area will be washed with sterile normal saline and a layer of silversulfadiazine cream is applied and will be dressed with sterilized gauze and bandaged
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
A second degree burn wound verified by the physician;
Patients age between 10 to 60 years;
Burn wound area less than 15% of total body surface;
The time of burn incidence less than 6 hours before starting treatment;
Patients with normal range of hemoglobin and total serum protein;
No applied medication to the burn wound except for tap water.
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Intervention groups
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control group: silver sulfadiazine 1 time per day for 14 days
intervention group: polyphenol of green tea formulation 1 times per day for 14 days
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Main outcome variables
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determination of Bets-Jensen score of burn surface area on the 3rd 5th 7th and 15th day compared to initial day in control and intervention group
General information
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Reason for update
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1) complete IRCT registration is mandatory before the commencement of clinical trial and recruitment of patients. Due to unforeseen circumstances which the researcher faced unexpectedly in final acceptance of IRCT process, the actual start date of the patient recruitment was different from expected commencement date.
I have received the introduction letter from university on 2019/4/16 after the ethical committee and IRCT acceptance . before this date ( without introduction letter) the researcher didn't had permission to present in the hospital. By this letter I was officially allowed to work in the hospital and I started my patient recruitment on the same date. This letter can be verified from research deputy of Ahvaz Jundishapur university by using the number 183/D/20/8/P .
2) To confirm the validity of the results and statistical calculations obtained by the static specialist the number of patients were increased from 30 to 50 and age range from 10 to 60.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20111105008013N7
Registration date:
2019-02-16, 1397/11/27
Registration timing:
prospective
Last update:
2021-11-03, 1400/08/12
Update count:
1
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Registration date
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2019-02-16, 1397/11/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-04, 1397/10/14
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Expected recruitment end date
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2019-04-03, 1398/01/14
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Actual recruitment start date
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2019-04-16, 1398/01/27
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Actual recruitment end date
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2019-08-20, 1398/05/29
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Trial completion date
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2019-09-20, 1398/06/29
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Scientific title
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Clinical study of healing effect of topical green tea polyphenols ointment on the second degree burn wounds in patients referred to Taleghani Burn Hospital in Ahvaz
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Public title
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effect of Grean tea on burn wounds
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
A second degree burn wound verified by the physician
Burn wound area should be less than 15% of total body surface
The time of burn incidence should be less than 6 hours before starting treatment
The patients should have normal range of hemoglobin and total serum protein
No medication except tap water should have been applied to the burn wound
Exclusion criteria:
wounds contaminated with excess materials
patients taking immune suppressive drugs such as corticosteroids , chemotheraputic drugs or undergoing radiation therapy
patients suffering from immune deficiency-associated diseases such as diabetes, cancer, or any metabolic disease.
patients suffering from any symptomatic infection
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Age
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From 10 years old to 60 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
30
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Permuted block randomization with quadruple blocks. blocks are produced by use of the online site (www.sealedenvelope.com).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Unique codes for each patient, generated by the software, will be used on the drug boxes. During the project, the randomization list will be kept with the statistician, and other participants in the project will not be aware of the assigned groups.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-30, 1397/09/09
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Ethics committee reference number
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IR.AJUMS.REC.1397.660
Health conditions studied
1
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Description of health condition studied
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2nd degree burn wound
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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comparison of healing of the wound
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Timepoint
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First day then 3 and 7 day later
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Method of measurement
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Bets Jensen wound assessment tool
Intervention groups
1
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Description
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Intervention group: Herbal cream 1 time a day for maximum 2 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: silver sulfadiazine cream 1 time a day for max 2 week
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Only a part of the data will be shared
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When the data will become available and for how long
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The access period will be 6 months after the publication of the results
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To whom data/document is available
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The obtained data from current study will be available only for researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis
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From where data/document is obtainable
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Applicants can be contacted with corresponding author by e-mail
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What processes are involved for a request to access data/document
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Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one month
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Comments
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