The objective of this clinical trial is to evaluate the effect of herbal essential oil of Thyme on infection control of second-degree burns wounds. Study groups: outpatients and inpatients of ValiAsr hospital will enter to the study. Sample size: A total of 60 patients will be admitted with obtaining informed consent. This study is not blinded and patients will be randomly divided into two groups of control (n = 30) and intervention (n = 30). Major eligibility criteria of participants: patients with second degree burn wounds; In-patients or Out-patients; Patients Aged 14 to 50 Years ; patients of both sexes; preferably within 24 hours of burning; and informed consent form. Exclusion criteria: diseases; electrical; chemical; respiratory burns; pregnant women; old burns for both groups; the standard treatment will be performed. For the test group, in addition to standard therapy, diluted essential oil will use. Grid and depth of wound in both control and experimental groups before and after the intervention will be assessed by the investigator. Primary outcome time point will be measured before the intervention and every 3 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032726394N3
Registration date:2017-05-28, 1396/03/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Mohammad Arjomandzadegan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
arjomandzadegan@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Thyme essential oil on infection control of second-degree burns wounds
Public title
Infection control in burn wounds by herbal material
Purpose
Treatment
Inclusion/Exclusion criteria
Major eligibility criteria of participants: patients with second degree burn wounds; Inpatients or outpatients; Patients Aged 14 to 50 Years ; patients of both sexes; preferably within 24 hours of burning; and informed consent form.
Exclusion criteria: other serious diseases; electrical; chemical; respiratory burns; pregnant women; old burns
Age
From 14 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Ethics committee of Arak University of Medical Sciences, Vice chancellor for research
City
Arak
Postal code
3819693345
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.ARAKMU.REC.1395.108
Health conditions studied
1
Description of health condition studied
infection control in burn wounds
ICD-10 code
X10; X11;
ICD-10 code description
Contact with hot drinks, food, fats and cooking oils; Contact with hot tap-water; Contact with other hot fluids
Primary outcomes
1
Description
Wound surface
Timepoint
The ulcer would be follow up during two weeks and at the end of three days the ulcer will be assessed.
Method of measurement
photography will be done by camera from patients wounds.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Rinse with saline and Silver ointment.
In addition, the thyme essential oil diluted spray on the wound, 1 to 5 times/day, depending on the patient's condition. Wound healing will evaluate.
Category
Treatment - Drugs
2
Description
Control group: Rinse with saline and Silver ointment and treated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infectious Diseases Research Center, Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arjomandzadegan
Street address
Infectious Diseases Research Center, Medicine Faculty, Arak University of Medical Sciences
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences, Arak, IR. IRAN
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice chancellor for research,Pardis of Arak University of Medical Sciences, Basidj Bridge, Sadasht, Arak, IR. IRAN
City
Arak
Grant name
2691
Grant code / Reference number
2691
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences, Arak, IR. IRAN
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Infectious Diseases Research Center, Arak University of Medical Sciences
Full name of responsible person
Ghasem Habibi Dehfooli
Position
Research Assistant
Other areas of specialty/work
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
Email
ghasemhabibi.chem@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infectious Diseases Research Center, Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Position
Associate Professor
Other areas of specialty/work
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
Email
mmatinam81@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Infectious Diseases Research Center, Arak University of Medical Sciences
Full name of responsible person
Marjan Salehi
Position
Research Assistant
Other areas of specialty/work
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
Email
mmatinam81@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)