Protocol summary
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Study aim
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Evaluation of the effect of essential oil on the prevention of second-degree burn wound infection
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Design
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Among the incidents that endanger the health and life of humans, burn injury is one of the hardest of them. This study is a study in which a thyme medicine herb is used to complete the treatment of burn patients. So that patients with burns, in addition to fulfilling the orders of the respected physician and taking the prescribed medications for them, the soluble thyme essential oil will be placed on the wounds of burn patients.
The use of herbal medicines and essential oils has long been traditionally used and the benefits of it are now of great interest to researchers. Previously, by the same group of researchers, the same thing has been done on a laboratory mouse and there are significant therapeutic effects observed.
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Settings and conduct
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Clinics and burn wards of Vali Asr Hospital in Arak are included in the plan.
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Participants/Inclusion and exclusion criteria
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Age from 2 to 10 years old, no underlying disease other than diabetes, first-degree and two-layer and deep burn wounds
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Intervention groups
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Invention group: Patient with second-degree burn wound, out- patients or In-patients in Valiasr Hospital, aged 2 to 10 years, patients of both sexes will be treated by silver sulphophylazine ointment as well as by diluted Thyme essential oil.
Control group: patients with second-degree burns, out- patients or In-patients, who only receive treatment only with silver sulphophylazine ointment .
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Main outcome variables
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Evaluation and comparing the size of the wound between both groups
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161017030336N1
Registration date:
2018-12-03, 1397/09/12
Registration timing:
registered_while_recruiting
Last update:
2018-12-20, 1397/09/29
Update count:
1
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Registration date
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2018-12-03, 1397/09/12
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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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2018-05-22, 1397/03/01
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Expected recruitment end date
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2019-05-22, 1398/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of Zataria thyme essential oil on controlling inflammation of second degree burn wounds in children
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Public title
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Effects of Zataria thyme essential oil on controlling inflammation of second degree burn wounds in children
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 2 and 10 years old.
Having no underlying disease other than diabetes.
The presence of first and second degree superficial burns.
Exclusion criteria:
Unwillingness to continue treatment
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Age
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From 2 years old to 10 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Control and intervention groups will be selected randomly using random number table.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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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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2017-12-03, 1396/09/12
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Ethics committee reference number
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IR.ARAKMU.REC.1396.217
Health conditions studied
1
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Description of health condition studied
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Burn of second degree of head and neck
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ICD-10 code
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T20.2
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ICD-10 code description
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Burn of second degree of head and neck
2
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Description of health condition studied
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Burn of second degree of trunk
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ICD-10 code
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T21.2
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ICD-10 code description
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Burn of second degree of trunk
3
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Description of health condition studied
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Burn of second degree of shoulder and upper limb
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ICD-10 code
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T22.2
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ICD-10 code description
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Burn of second degree of shoulder and upper limb
4
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Description of health condition studied
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Burn of second degree of wrist and hand
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ICD-10 code
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T23.2
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ICD-10 code description
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Burn of second degree of wrist and hand
5
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Description of health condition studied
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Burn of second degree of hip and lower limb
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ICD-10 code
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T24.2
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ICD-10 code description
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Burn of second degree of lower limb, except ankle and foot
6
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Description of health condition studied
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Burn of second degree of ankle and foot
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ICD-10 code
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T25.2
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ICD-10 code description
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Burn of second degree of ankle and foot
Primary outcomes
1
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Description
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Wound surface
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Timepoint
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The ulcer would be follow up during two weeks and at the end of three days the ulcer will be assessed.
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Method of measurement
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photography will be done by camera from patients wounds.
Intervention groups
1
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Description
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Intervention group: This group is treated with normal saline and silvered ointment. In addition, spraying diluted thyme essential oil spray 1-2 times depending on the patient's condition. Wound healing condition is checked.
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Category
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Treatment - Drugs
2
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Description
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Control group: This group is washed with normal saline and with silver ointment. they receive. Then sterile gas impregnated with silver sulfadiarin ointment is laid on the wound and closed with the band. This is done 1-2 times a day, depending on the patient's condition. The condition for wound healing is checked.
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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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2940
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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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Research Assistant of Arak 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable