Investigating the restorative effects of the local spray of effective plant substances on burn wounds of patients with 1st and 2nd-degree burns.
Design
This study is a 3-blind randomized clinical trial and is conducted on 40 patients who are selected by the available sampling method and based on the inclusion criteria and randomly divided into 4 groups of ten.
Settings and conduct
The research starts from the first appearance of first-degree burn symptoms in the hospital. During the study period, the surface area of the burn wound is measured every 24 hours until the burn wound is completely healed. The examining doctor and nurse, the patient and the statistical analyst are blinded in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age group from 10 to 70 years
- Having first and second-degree burns, at least one square centimeter of the skin surface
- Full alertness and being able to understand instructions and self-care (including not rubbing, touching and scratching the burn site)
Exit criteria:
- History of allergy to herbal medicines
- Use of anti-inflammatory drugs (glucocorticosteroids, NSAIDs) in the last three months
- The presence of a skin lesion that prevents the examination of burns
- Diabetic patients and diabetic ulcers
Intervention groups
The first group received Silver Sulfadiazine SSD cream in the burned areas every morning and received herbal topical spray 12 hours later.
The second group receives topical plant spray on the mentioned areas every day both in the morning and 12 hours later.
The third group, the positive control group, received SSD every morning and twelve hours later.
The fourth group, the placebo control group, received SSD every morning and twelve hours later placebo or Oserin.
Main outcome variables
The surface of the lesion; color of the lesion; the presence of pain; degree of dryness of the lesion; satisfaction level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240309061227N1
Registration date:2024-05-14, 1403/02/25
Registration timing:registered_while_recruiting
Last update:2024-05-14, 1403/02/25
Update count:0
Registration date
2024-05-14, 1403/02/25
Registrant information
Name
Firouz Payervand
Name of organization / entity
Novin Medical Radiation Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 1199
Email address
fpayervand@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the healing effects of topical spray containing effective herbal ingredients on burn wounds of patients with grade 1 and 2 burn wound
Public title
Investigating the effect of burn wound healing spray.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 10 to 70 years
Having first and second-degree burns, at least one square centimeter of the skin surface
Fully alert and able to understand instructions and self-care (including not rubbing, touching and scratching the burn site)
Exclusion criteria:
History of allergy to herbal medicines
History of asthma, COPD, hay fever, skin allergy
Use of anti-inflammatory drugs (glucocorticosteroids, NSAIDs) in the last three months
The presence of a skin lesion that prevents the examination of burns
Diabetic patients with diabetic ulcers
Concurrent participation in at least one other clinical trial affecting burns
Age
From 10 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the patients, the random block method with a block size of four is used. For this purpose, four sheets of paper are prepared. The letter T (test) is written on two sheets and the letter C (control) is written on the other two sheets. The sheets are mixed and placed in a box. With each eligible patient's visit, one of the sheets is randomly drawn and based on whether the drawn sheet is T or C, it is assigned to one of the two test or control groups. It should be noted that the drawn cards are not returned to the box until all four cards have been drawn. After randomly pulling out all four sheets, all the sheets are returned to the corresponding box and the above procedure is continued for the next four patients until the desired sample size is reached.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The bottles containing the solution of herbal active ingredients are marked as X and the bottles containing the placebo are marked as Y, and only the researcher is aware of the contents of the spray bottles; The examining doctor and nurse, the patient himself and the statistical analyst, none of them know about the content inside the labelled bottles.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Blvd., Central Headquarters of University of Medical Sciences, Hamadan, Iran
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
IR.UMSHA.REC.1402.718
Health conditions studied
1
Description of health condition studied
ترمیم زخم، سوختگی
ICD-10 code
T30.0
ICD-10 code description
Burn of unspecified body region, unspecified degree
Primary outcomes
1
Description
Recovery percentage
Timepoint
daily during the entire study period
Method of measurement
Recovery percentage will be calculated using the formula.
2
Description
Duration of treatment with herbal formulation
Timepoint
Daily
Method of measurement
The time interval between the start of treatment and recovery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: that every morning Silver Sulfadiazine SSD cream is applied to the areas with 1st and 2nd degree burns to the extent that the radius of the burned area is covered, and 12 hours later they receive local herbal spray on the said areas.
Category
Treatment - Drugs
2
Description
Intervention group: Every day, both in the morning and 12 hours later, they receive a local plant spray on the mentioned areas.
Category
Treatment - Drugs
3
Description
Control group: Positive control group that received SSD every morning and twelve hours later.
Category
Treatment - Drugs
4
Description
Control group: Placebo control who received SSD every morning and placebo or Oserin twelve hours later on the mentioned areas to the extent that covers the burn surface.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Pari Tamri
Street address
Shahid Fahmideh Blvd., Central Headquarters of University of Medical Sciences, Hamadan, Iran
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
ptamari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Pari Tamri
Street address
5th floor, Central Headquarters of University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
ptamri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Novin Medical Radiation Institute
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Novin Medical Radiation Institute
Full name of responsible person
Firouz Payervand
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Radiobiology and Radio safety
Street address
Novin Medical Radiation Institute, 5th St., South Piroozan St., Hormozan St., Khovardin Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1466643691
Phone
+98 21 8863 1199
Fax
+98 21 8863 1199
Email
fpayervand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Novin Medical Radiation Institute
Full name of responsible person
Firouz Payervand
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Radiobiology and Radio safety
Street address
Novin Medical Radiation Institute, 5th St., South Piroozan St., Hormozan St., Khovardin Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1466643691
Phone
+98 21 8863 1199
Fax
+98 21 8863 1199
Email
fpayervand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Novin Medical Radiation Institute
Full name of responsible person
Firouz Payervand
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Radiobiology and Radio safety
Street address
Novin Medical Radiation Institute, 5th St., South Piroozan St., Hormozan St., Khovardin Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1466643691
Phone
+98 21 8863 1199
Fax
+98 21 8863 1199
Email
fpayervand@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data related to the effectiveness (qualitative and quantitative) of the medicine used by each participant can be shared.
When the data will become available and for how long
The data will be shared immediately after the results are published in reputable journals.
To whom data/document is available
The data will be available to researchers and industry practitioners.
Under which criteria data/document could be used
The data can be used provided that the source is cited and referenced to the original study conducted by the executive team of this research, and their material and intellectual rights are respected.
From where data/document is obtainable
The person responsible for coordinating the receipt of data and information is as follows:
Dr. Firouz Payrvand
Novin Medical Radiation Institute
fpayervand@yahoo.com
02188086783
What processes are involved for a request to access data/document
After communicating with the mentioned responsible person, the required data will be provided with the mentioned conditions within 1 month.