Protocol summary
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Study aim
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Effect of thyme essential oil on control of pilonidal sinus ulcer infection after surgery
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Design
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This study is a research project in which a medicinal herb "Thyme" available in the herbal remedies will be used to complete the treatment of patients with pilonidal sinus ulcer after surgery. Patients will then be placed on the wound, in addition to practicing the instructions of the physician and taking the prescribed medications, the soluble thyme essential oil will be placed.
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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Clinic and Surgery Department of Vali-e-Asr Hospital and Amiral-Momenin Hospital
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Participants/Inclusion and exclusion criteria
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age 14-60 years, patients of both sexes, referrals, preferably within the first 24 hours after surgery, and completion of informed consent form
Exit criteria: underlying diseases , burns, open and associated bleeding ulcers
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Intervention groups
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The study was not blinded and patients were randomly divided into three groups of 30.A common treatment group includes: normal saline washing and sterile gauze dressing, and the second group, in addition to the usual treatment of silver sulfadiazine ointment, and the third group, in addition to the usual treatment, receive herbal treatment.
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Main outcome variables
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Evaluation and comparing the size of the wound between three 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:
IRCT20161017030336N4
Registration date:
2018-12-10, 1397/09/19
Registration timing:
registered_while_recruiting
Last update:
2021-05-04, 1400/02/14
Update count:
2
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Registration date
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2018-12-10, 1397/09/19
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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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2018-08-24, 1397/06/02
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Expected recruitment end date
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2019-08-24, 1398/06/02
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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 essential oil on control of pilonidal sinus ulcer infection after surgery
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Public title
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Effect of thyme essential oil on control of pilonidal sinus ulcer infection after surgery
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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 sore
Hospitalized or non-hospitalized
Age between 14 and 60 years
Patients of both sexes
Referral preferably in the first 24 hours after surgery
Completion of informed consent form
Exclusion criteria:
Underlying diseases (diabetes, hypoxic and ...)
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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N/A
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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:
90
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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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2018-01-02, 1396/10/12
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Ethics committee reference number
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IR.ARAKMU.REC.1396.277
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
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ICD-10 code description
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Complications of procedures, not elsewhere classified
2
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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 surface
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Timepoint
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In the first 24 hours after surgery to one month
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Method of measurement
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Patients' wounds are followed for two weeks and at the end of every three days to one month, the wounds of patients are evaluated.
Intervention groups
1
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Description
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Washing with normal saline, spraying diluted thyme essential oil spray on the wound, then 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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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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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