Protocol summary
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Study aim
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Effect of thyme essential oil on the control of sutured wound infection
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Design
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Sixty patients are selected after getting their informed consent. The study is not blinded and the patients are randomly divided into two groups of intervention and control groups of 30. Standard treatment are performing for both groups. For the test group, in addition to the standard treatment, diluted Thyme essential oil is used. The ulcer in both control and test groups is evaluated by the investigator before and after intervention.
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Settings and conduct
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Vali Asr Hospital in Arak
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Participants/Inclusion and exclusion criteria
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Patients with a stitched ulcer,
Hospitalization or non-hospitalization؛
age between 14 to 60 years,
Both sexes؛
Referral preferably in the first 24 hours after surgery,
Completion of informed consent form؛
Exclusion criteria: underlying diseases, burns, open and associated bleeding ulcers
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Intervention groups
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Standard treatment is delivered for both groups. For the test group, in addition to standard treatment, diluted oil is also used.
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Main outcome variables
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Infection of stitched wounds
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:
IRCT20161017030336N2
Registration date:
2018-12-03, 1397/09/12
Registration timing:
registered_while_recruiting
Last update:
2019-02-19, 1397/11/30
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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2018-08-23, 1397/06/01
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Expected recruitment end date
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2019-08-23, 1398/06/01
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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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Effect of Thyme Essence on Infection Control of Sutured Wounds
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Public title
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Effect of Thyme Essence on Infection Control of Sutured Wounds
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The patient has a stitched wound,
Inpatient or non-hospitalized, ages 14 to 60 years,
Patients of both sexes'
Referral preferably in the first 24 hours after surgery,
Completion of informed consent form.
Exclusion criteria:
Underlying diseases,
Burns,
Open wounds,
bleeding
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Age
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From 14 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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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization, so that the patients included in the study are all divided into two equal groups. One of the groups is considered as the treatment group and the other group is considered.
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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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2018-01-03, 1396/10/13
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Ethics committee reference number
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IR.ARAKMU.REC.1396.279
Health conditions studied
1
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Description of health condition studied
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Complications of surgical wound
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ICD-10 code
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T81.4
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ICD-10 code description
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Infection following a procedure
Primary outcomes
1
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Description
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Wound infection with discharge test
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Timepoint
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Daily for first 72 to 96 hours after surgery, then every 3 days for up to one month
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Method of measurement
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clinical examination
Intervention groups
1
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Description
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First intervention group: Washing with normal saline, spraying diluted thyme essential oil spray on the wound, put sterilized gas impregnated with diluted essential oil on the wound and closed with the band. This is done 1-2 times a day, depending on the patient's condition.
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Category
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Treatment - Drugs
2
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Description
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Second intervention group: Normal saline was washed with silver sulfadiazine ointment. 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.
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Category
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Treatment - Drugs
3
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Description
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Control group: Normal saline and sterile gauze dressing. Then the sterilized sterilized gas with normal saline is laid on the wound and closed with the band. This is done 1-2 times a day, depending on the patient's condition.
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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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2977
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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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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable