Evaluation of the effect of herbal ointment with silversulfadiazine ointment on second-degree burn injuries in patients referred to emergency department of Motahari Hospital in Tehran in 2019,20
Design
A double-blind clinical trial with parallel groups including treatment groups with herbal ointment and silver sulfadiazine ointment, randomizing by randomizer software and sample size of 54 cases including 27 cases in each groups
Settings and conduct
The statistical population of this study is patients with second-degree burns referring to Motahari hospital in Tehran, who are over 18 years of age and have criteria for entering the study. A thin layer of herbal ointment or silver sulfadiazine ointment based on randomization of patients, and without informing the patients about the contents of the ointment cans, is applied to their burn wounds. Patients are required to come back to the hospital for dressing change, evaluation of wounds and assessing for possible complications. Before each dressing change, the wounds are evaluated and digital images are taken from the wounds.In the group receiving herbal ointment, intervention is continued until the end of the fourth week, but in the group receiving silver sulfadiazine ointment, the base of the herbal ointment is used to continue the intervention from start of third week until the end of the fourth week.
Participants/Inclusion and exclusion criteria
Second degree heat burn;
age over 18 years;
Less than 48 hours from the burns happening;
Burn percentage less than 15%;
Patient's informed consent to participate in the research project.
Intervention groups
group 1: Wound dressing with a thin layer of herbal ointment daily until complete wound healing
group 2: Wound dressing with a thin layer of silver sulfadiazin 1% ointment daily until complete wound healing
Main outcome variables
wound healing time, wound size changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190621043961N1
Registration date:2019-10-03, 1398/07/11
Registration timing:registered_while_recruiting
Last update:2019-10-03, 1398/07/11
Update count:0
Registration date
2019-10-03, 1398/07/11
Registrant information
Name
Mehdi Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4601 6943
Email address
m_alizadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of herbal ointment with silver sulfadiazine ointment on second degree burn wounds
Public title
The effect of herbal ointment on second degree burn wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
second degree burn wound
age over 18 years
less than 48 hours from the onset of burn injury
Burn percentage less than 15%
Informed consent to participation in research
Exclusion criteria:
Pregnant women
Patients with severe systemic diseases such as epilepsy, diabetes, immune deficiency
History of psychotic disorder such as paranoid; history of admission to psychiatry department
Patients with a history of skin allergies to the components of the product
Electrical and chemical burns
Unwillingness to continue the intervention
Allergy to Silver Sulfadiazine or Ointment
Co-administration of antibiotics (oral and topical)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
57
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the samples is done by Randomizer software in a simple random way for patients with inclusion criteria. With using Randomizer software،sequential numbers randomly divided into two groups of intervention and control. Then patients referred to the intervention or control group will be placed in the same order. For patients with two burn areas, each area from the right to the left (conventionally) is considered a number.
Blinding (investigator's opinion)
Single blinded
Blinding description
Dressing change of the patients is done daily in the hospital and the patients do not know the type of prescribed ointment and also because before each dressing, wounds are washed and clean by the patients at home, the assessor also do not aware of the type of wound treatment group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
At first and the fourth day, then at the end of the first, second, third and fourth weeks
Method of measurement
photography and slide-calliper
Secondary outcomes
1
Description
general wound appearance
Timepoint
days 1, 4, 7 and at the end of second, third and fourth weeks
Method of measurement
observation
2
Description
Pain
Timepoint
daily
Method of measurement
VAS scale
3
Description
itching
Timepoint
daily
Method of measurement
Visual analog scale
4
Description
inflamation
Timepoint
daily
Method of measurement
observastion
5
Description
percentage of wound contraction
Timepoint
days 1, 4, 7 and at the end of second, third and fourth weeks
Method of measurement
photography and calliper
6
Description
infection
Timepoint
daily
Method of measurement
observation
7
Description
redness
Timepoint
daily
Method of measurement
observation
Intervention groups
1
Description
Intervention group: wound dressing with a thin layer of herbal ointment daily until the end of one month after the start of intervention.
Category
Treatment - Drugs
2
Description
Control group: wound dressing change with a thin layer of silver sulfadiazine 1% ointment daily until complete wound healing and then until the end of a month after the onset of intervention, the base of ointment replaces the silversulfadiazine ointment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Mehdi Alizadeh
Street address
Rashid Yasemi Ave., Kordestan Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
146651194
Phone
+98 21 8877 0031
Email
hospital.motahari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Alizadeh
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
m_alizadeh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Alizadeh
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
m_alizadeh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Alizadeh
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
m_alizadeh@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Publishing results in form of a PhD thesis and an article indexing in ISI
When the data will become available and for how long
after PhD thesis defence
To whom data/document is available
Public
Under which criteria data/document could be used
for research reasons
From where data/document is obtainable
Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document