Comparison of the effect of sesame oil and 1% silver sulfadiazine ointment on the pain, healing and scarring of burn wounds
Design
Clinical trial, double-blind with parallel groups, randomized, in phase 3, 40 patients will be selected as available and allocated by permutation blocks method.
Settings and conduct
The place of intervention was the emergency department of Bohloul hospital.
For the sesame oil group, first, the wound area will be washed with sodium chloride and exposed to the open air for 5 minutes until it dries completely. Then, the wound area is smeared with 2 ml of sesame oil (for 10 square centimeters of the wound) and the surface of the wound is covered with freezer plastic and then it will be bandaged.
For the silver ointment group, all the above steps have been done and the wound will be dressed with 1% silversulfadiazine ointment.
At the end, the diagnosis of wound healing will be confirmed by a specialist.
The emergency medicine physician and the data analyst will be unaware of the patient grouping.
Participants/Inclusion and exclusion criteria
Informed consent to participate in the study
Age 20-60 years
First and second degree burns with an extent of 1-10%
Burns due to contact with a heat source or liquids
Less than 6 hours passed from the time of the burn to the time of going to the treatment center
Hemoglobin and total protein normal
Absence of underlying diseases such as anemia, diabetes, cardiovascular diseases, malignancy and immune system deficiency
Not taking painkillers and NSAIDs orally or topically until the first visit to the treatment center
Confirmation by the doctor that the patient does not need to be hospitalized
Not allergic to sesame oil
Intervention groups
Dressing group with sesame oil, will be dressed with sesame oil.
Dressing group with 1% silver sulfadiazine ointment, will be dressed with silver ointment.
Main outcome variables
Healing & scars
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180221038821N5
Registration date:2023-02-05, 1401/11/16
Registration timing:registered_while_recruiting
Last update:2023-02-05, 1401/11/16
Update count:0
Registration date
2023-02-05, 1401/11/16
Registrant information
Name
Iman Ghorbany Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 0576
Email address
ghorbani.i@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sesame oil and 1% silver sulfadiazine ointment on the pain, healing and scarring of burn wounds
Public title
Comparison of the effect of sesame oil and 1% silver sulfadiazine ointment on the pain, healing and scarring of burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Age 20-60 years
First and second degree burns with an extent of 1-10%
Burns due to contact with a heat source or liquids
Exclusion criteria:
Sesame oil allergy
Confirmation of the need for hospitalization of the patient by the doctor
Taking painkillers and NSAIDs orally or topically until the first visit to the treatment center
Background diseases such as anemia, diabetes, cardiovascular diseases, malignancy and immune system defects
Abnormal hemoglobin and total protein
More than 6 hours passed from the time of the burn to the time of going to the medical center
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were first selected by the available method and then divided into two groups of sesame oil and silver ointment by using 4 permutation blocks. In this method, the sesame oil group was coded with the letter A and the silver ointment group was coded with the letter B. The six possible states in the blocks included ABAB, BBAA, AABB, BABA, AAAA, BBBB, and each block was assigned a number. For every four selected people, a number will be selected according to the list, and people will be assigned to two groups of sesame oil and silver ointment in this way.
Blinding (investigator's opinion)
Double blinded
Blinding description
The emergency medicine doctor who will confirm the recovery of the patients will not know about the grouping of the patients.
The data analyst will also be unaware of the grouping of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnical Committee of Gonabad University of Medical Sciences
Street address
Asian Road Rim, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
96916-47161
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.GMU.REC.1401.137
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
Z73.0
ICD-10 code description
Burn-out
Primary outcomes
1
Description
Wound healing time
Timepoint
After confirming the healing of the wound by an emergency medicine specialist
Method of measurement
Questionnaire (Day)
2
Description
The scar left by the wound
Timepoint
After confirming the healing of the wound by an emergency medicine specialist
Method of measurement
Beitz-Johnson Burn Wound Assessment Tool
Secondary outcomes
1
Description
Intensity of pain
Timepoint
Before and after dressing in the first session
Method of measurement
Visual pain scale
Intervention groups
1
Description
Intervention group: Sesame oil group: For the sesame oil group, the burn wound dressing with sesame oil will first be washed with sodium chloride for washing and exposed to the open air for 5 minutes until it dries completely. Then, the wound area is smeared with 2 ml of sesame oil (for 10 square centimeters of the wound) and the surface of the wound is covered with freezer plastic (to absorb more sesame oil) and then it will be bandaged. Sesame oil used in this notice will be completely natural and without preservatives with standard devices from a local store and will be prepared under supervision. It should be noted that this extract is 100% oily and in addition to being free of water molecules, it also contains antimicrobial compounds that prevent the growth of microbial agents in this extract. Nevertheless, in order to ensure the negativity of the microbial culture, random samples of the extract prepared in the microbial culture media of blood agar, chocolate agar, eosin methylene blue, Kant agar plate, lauryl sulfate broth and selected culture media for the investigation of yeasts and fungi will be used.
Category
Treatment - Drugs
2
Description
Intervention group: Silversulfadiazine 1% group: Dressing the burn wound first, the wound area will be washed with normal saline for washing and exposed to the open air for 5 minutes until it dries completely. Then the wound will be smeared with 1% silver sulfadiazine ointment and covered with freezer plastic and bandaged. One percent silver sulfadiazine ointment of Iran Najo Pharmaceutical Company will also be used for this group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bohlol Hospital, Gonabadi
Full name of responsible person
Dr. Mehdi Pasban
Street address
Parastar Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Email
info@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Mansourian
Street address
Asian Roads, Gonabad University of Medical Sciences, Student Research Committee
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Iman Ghorbany Moghaddam
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691647161
Phone
+98 51 5722 0576
Fax
Email
imanghorbany135213@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Moosa Sajjadi
Position
Head of the Center for the Study and Development of Medical Sciences Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Asian Roads, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Email
sajjadi1975@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Iman Ghorbany Moghaddam
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691647161
Phone
+98 51 5722 0576
Fax
Email
imanghorbany135213@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available