Evaluation of efficacy and safety of Homagin burn ointment for healing the second degree burn wounds
Design
Single group, phase 2, before -after clinical study. sample size is 24.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 24 Man or woman with second degree Burning area under 10% will be selected and enrolled in the study after signing consent form. Wounds are first washed with normal saline.Homagin ointment with a diameter of 3 to 5 mm is placed on the wound and bandaged with sterile gauze.The patients are taught to change the wound dressing daily until the wound is completely healed. Before intervention and at the end of 7 and 14 days later changing in burning parameters will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 18-60 years old, Heat Burning, Man or woman with second degree Burning area under 10%, Less than 6 hours of burning, Willing and able to sign an informed constant answering the questions.
Exclusion criteria: Other kind of burning like Chemical or Electrical Burning and etc.., impregnated Wound with contaminating material,Using any topical preparation on wound before treatment except taped water, Active, untreated infection in different parts of the body, Concomitant diseases including; cancer , HIV , diabetes or untreated Hypertension and..,Burn in the facial and genital areas,Pregnancy or lactating
Intervention groups
Using Homagin ointment in 3 to 5 mm diameter on burning wound and bandaged with sterile gauze
Main outcome variables
Change in burn wound condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N12
Registration date:2021-04-06, 1400/01/17
Registration timing:registered_while_recruiting
Last update:2021-04-06, 1400/01/17
Update count:0
Registration date
2021-04-06, 1400/01/17
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of Homagin burn ointment for healing the second degree burn wounds
Public title
Evaluation of efficacy and safety of Homagin burn ointment for healing the burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18-60 years old
Heat Burning
Man or woman with second degree Burning area under 10%
Less than 6 hours of burning
Willing and able to sign an informed constant answering the questions
Exclusion criteria:
Other kind of burning like Chemical or Electrical Burning and etc..
impregnated Wound with contaminating material
Using any topical preparation on wound before treatment except taped water
Active, untreated infection in different parts of the body
Concomitant diseases including; cancer , HIV , diabetes or untreated Hypertension and..
Burn in the facial and genital areas
Pregnancy or lactating
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-02-20, 1399/12/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1167
Health conditions studied
1
Description of health condition studied
second degree burn wounds
ICD-10 code
T21.21XA
ICD-10 code description
Burn of second degree of chest wall, initial encounter
Primary outcomes
1
Description
Change in burn wound condition
Timepoint
Before intervention, 1 and 2 weeks after last treatment
Method of measurement
bates-jensen Wound assessment tool
Secondary outcomes
1
Description
Change in wound area
Timepoint
Before intervention, 1 and 2 weeks after last treatment
Method of measurement
Using Colis Vernier
2
Description
Change in the amount of pain and burning
Timepoint
Before intervention, 1 and 2 weeks after last treatment
Method of measurement
according to the VAS criteria
Intervention groups
1
Description
Intervention group: 2 weeks, daily application of Homagin ointment, containing curcumin and honey, product of Terita Sana Darman company (Iran) . The ointment will be applied in 3 to 5 mm thickness on burning wound. Before application, the wound will be washed by normal saline and then will be dressed up using sterile gauze.