The aim of this clinical trial study is to compare the honey wax and olive oil with Sulfadiazine 1% on the pain and wound healing of second-degree burn patients. The sampling in this study is convenient method.This study will conduct on 35 outpatient with 5-60 years old who refer to the clinic of Beasat hospital. The inclusion criteria is two separated second- degree burn wounds; Burn with maximum 15 percent of extent; lack of diseases such as malnutrition and diabetes; age between 5-60 years old and Exclusion criteria consists of: Head and neck burns; perineal and penile shaft burns; referring more than 6 to 8 hours; hospitalization; washing the burn with another liquid except water.The method of study is so that after referring to the hospital, patients who have two burn wound and have the inclusion criteria will be selected and then one of the wounds by randomly blocking method will be dressed with sulfadiazine 1% and another by Honey Wax and Olive oil. In the first 3-5 days, once a day and then every other day dressing is done and this work will continue for three weeks.
During this time the wound will be assessed by using checklists of burn wound healing and Visual Analogue Scale (VAS) and the two wounds will be compared for healing and pain during wound dressing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071325846N2
Registration date:2017-04-27, 1396/02/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-27, 1396/02/07
Registrant information
Name
Nahid Mohammadi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 9572
Email address
n.mohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor for research of Hamadan University of Medical Science
Expected recruitment start date
2017-04-15, 1396/01/26
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Clinical Trial of Comparison of Honey Wax and Olive Oil with Sulfadiazine1% on the pain and wound healing in patients with second-degree burn
Public title
The Clinical Trial of Comparison of Honey Wax and Olive oil with Sulfadiazine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Two separated second degree burn wounds; Burn with maximum 15%of extent; lack of diseases such as malnutrition and diabetes; age between 5-60 years old
Exclusion criteria: Head and neck burns; perineal and penile shaft burns; referring more than 6 to 8 hours; hospitalization; washing the burn with another liquid except water
Age
From 5 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Science
Street address
Shahid Fahmideh Avenue, University of Medical Science, Hamadan
City
Hamadan
Postal code
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
پ/16/35/9/2889
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T30.2
ICD-10 code description
Second-degree burn NOS
Primary outcomes
1
Description
pain
Timepoint
Every other day
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
wound healing
Timepoint
Every other day
Method of measurement
checklist of burn wound healing
Intervention groups
1
Description
Intervention group:Dressing with Honey and Olive Oil
Category
Treatment - Drugs
2
Description
Control group: Dressing with Sulfadiazine1%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Roya Amini
Street address
Shahid Fahmideh Avenue, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research, Hamadan University of Medical Science
Full name of responsible person
Saeid Bashirian
Street address
Shahid Fahmideh Avenue, Hamadan University of Medical Science, Hamadan
City
Hamadan
Grant name
پزوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research, Hamadan University of Medical Science
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
Hamadan University of Medical Science
Full name of responsible person
Nahid Mohammadi
Position
Faculty member
Other areas of specialty/work
Street address
Shahid Fahmideh Avenue, University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+46 8138249572
Fax
+98 81 3838 0447
Email
n.mohammadi@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Roya Amini
Position
Faculty Member
Other areas of specialty/work
Street address
Shahid Fahmideh Avenue, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 6033
Fax
+98 81 3838 0447
Email
aminiroy@gmail.com, r.amini@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Roya Amini
Position
Faculty Member
Other areas of specialty/work
Street address
Shahid Fahmideh Avenue, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 6033
Fax
+98 81 3838 0447
Email
aminiroy@gmail.com, r.amini@umsha.ac.ir
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)