Comparison of wound healing effect between silver ointment and coriander oil in patients with second degree burns
Design
Using random block method, the first group of 33 patients apply 1% silver sulfadiazine ointment at a rate of 200 mg per day and the second group of 33 patients apply coriander oil at a rate of 200 mg once a day on the burn areas.
After rinsing with normal saline serum, the wound is placed in the air for 5 minutes to dry. Spread a thin layer of sterile abscess on the wound and put a light dressing of sterile gas on it. Wound dressings are changed daily. When the wound has a clear appearance, pink color, odor and has a covering texture, it is considered improved. For scientific confidence, all silver ointments and coriander oil will be provided by a manufacturer. Every 7 days. Macroscopic recovery of patients is performed by a specialist observation and completion of a checklist. The checklist includes demographic characteristics and location and extent of the burn and the characteristics of the burn and the type of ointment used.
Settings and conduct
Wound healing rate according to ocular criteria in all burn patients referred to hospital burn ward
The rate of recovery is assessed every 7 days and the rate of recovery of both groups is compared
Participants/Inclusion and exclusion criteria
Inclusion criteria: All adult patients who present to the hospital with second-degree burns
Exclusion criteria: 1- Children 2- People who do not consent to participate in this study 3- People with underlying diseases Diabetes Immune system or use immunosuppressive drugs
Intervention groups
Intervention group: Using coriander oil in burns
Control group: use of silver ointment on burns
Evaluation of wound healing in two methods of silver ointment and coriander oil in patients with second degree burns
Public title
Evaluation of wound healing in two methods of silver ointment and coriander oil in patients with second degree burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who come to the hospital with a second-degree burn
Exclusion criteria:
Children
People who do not agree to participate in this study
People with underlying diseases of diabetes Immunodeficiency or use immunosuppressive drugs
Age
From 2 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two treatment groups A and B using the balanced block randomization method through https://www.sealedenvelope.com/simple-randomiser/v1/lists. The size of each block is 6 and the total number of blocks is 11 .
Balanced randomization allocation for the participants in the current study, the effect of silver sulfadiazine ointment 1% (A) and beneh oil (B) on wound healing is investigated.
Blinding (investigator's opinion)
Single blinded
Blinding description
Checklist information is provided by the secretary of the department in which people with national code are registered to the person responsible for the analysis and statistical analysis of the plan. After entering SPSS and coding 1 and 2, the results of the evaluation will be analyzed by the professor of statistics, separated into intervention and control groups (which only the secretary of the department knows about). and the professor of statistics is not aware of which medicinal ointment the patient received. The data analyst and the safety monitoring committee are not aware of which drugs the patients took.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qazvin University of Medical Sciences
Street address
Rajaei Hospital. Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2021-10-17, 1400/07/25
Ethics committee reference number
IR.QUMS.REC.1400.314
Health conditions studied
1
Description of health condition studied
burning
ICD-10 code
T31.1
ICD-10 code description
Burns involving 10-19% of body surface
Primary outcomes
1
Description
Epithelization of the tissues
Timepoint
Every seven days
Method of measurement
Complete wound closure visually
Secondary outcomes
1
Description
Time to complete burn wound healing
Timepoint
Every 7 days
Method of measurement
Based on ocular criteria
Intervention groups
1
Description
Intervention group: in the second group with 33 patients, coriander oil at the rate of 200 mg once a day is prescribed to be applied on the burned areas. In this way, after rinsing with normal saline serum, the wound is placed in the presence of air for 5 minutes to dry, and then a thin layer is spread on the wound with a sterile swab and a light dressing of sterile gas is placed on it. Wound dressings are changed daily until the wound heals.
Category
Treatment - Drugs
2
Description
Control group: in the first treatment group with 33 patients, 1% silver cesulfadiazine ointment at a dose of 200 mg per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaei hospital
Full name of responsible person
Younes Ehsanollali
Street address
Padegan
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Email
dr.y.ehsanollahy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Unes Ehsanollahy
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
medicine@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Unes Ehsanollahy
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
dr.y.ehsanollahy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Unes Ehsanollahy
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
dr.y.ehsanollay@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Unes Ehsanollahy
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
dr.y.ehsanollahy@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