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
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+silver sulfadiazine cream and control silver sulfadiazine cream treated group
Design
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 15 patients in each one. Randomized allocation will be based on computer-generated number.
Settings and conduct
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 followed by a layer of silver sulfadiazine cream 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
Participants/Inclusion and exclusion criteria
Inclusion criteria:
A second degree burn wound verified by the physician;
Patients age between 20 to 50 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.
Intervention groups
control group: silver sulfa diazine two times per day for seven days
intervention group: polyphenol of green tea formulation two times per day for seven days
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111105008013N7
Registration date:2019-02-16, 1397/11/27
Registration timing:registered_while_recruiting
Last update:2019-02-16, 1397/11/27
Update count:1
Registration date
2019-02-16, 1397/11/27
Registrant information
Name
Amir Siahpoosh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 2197
Email address
siahpoosh-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-04, 1397/10/14
Expected recruitment end date
2019-04-03, 1398/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
effect of Grean tea on burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with quadruple blocks. blocks are produced by use of the online site (www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی جندی شاپور اهواز
Street address
Taleghani hospital
City
ahvaz
Province
Khouzestan
Postal code
6135733184
Approval date
2018-11-30, 1397/09/09
Ethics committee reference number
IR.AJUMS.REC.1397.660
Health conditions studied
1
Description of health condition studied
2nd degree burn wound
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
comparison of healing of the wound
Timepoint
First day then 3 and 7 day later
Method of measurement
Bets Jensen wound assessment tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Herbal cream 3 times a day for one weeks
Category
Treatment - Drugs
2
Description
Control group: silver sulfadiazine cream 3 times a day for one week