Determine the Effectiveness of Bilva Ointment on the Outcome of Burn Sores
Design
Double blind clinical trial with parallel groups, who were selected in simple randomized method using table of random numbers. Final sample size was 34 patients.
Settings and conduct
The burn wards of men and women located in Sina Hospital will be considered as the research environment. First, qualified individuals will be included in the study after obtaining informed consent. Member (right or left) in the intervention group is determined by random numbers and stored in envelopes. These packs are determined by specimens without the intervention of the researcher and consequently by random allocation.
Participants/Inclusion and exclusion criteria
Patients with maximum 20% burning of the body surface and first degree burns without blister in the sympathetic organs with the same depth are included in the study. Patients with additional diseases, using substances other than drinking water on the burn are excluded from the study.
Intervention groups
An organ burned with silver sulfadiazine ointment 1% will be dressed in accordance with the routine of the hospital and its sympathetic section using Beiloy ointment. Other nursing care such as daily bath, primary wound healing with normal saline before dressing, management of blister wounds and ... will be the same for both members.
Main outcome variables
Wound healing,Pain,Itching,Infection,Hypertrophy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160424027561N11
Registration date:2018-08-30, 1397/06/08
Registration timing:retrospective
Last update:2018-08-30, 1397/06/08
Update count:0
Registration date
2018-08-30, 1397/06/08
Registrant information
Name
Mojgan Lotfi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
mlotfi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
" Study of the effectiveness of Bilva ointment on burn wound outcomes of patients admitted "
Public title
" Study of the effectiveness of Bilva ointment on burn wound outcomes of patients admitted"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 20% or less burns of second degree
The location of the burn in the symetric extremities with the same depth
Patients who do not have any underlying disease such as diabetes mellitus, allergic skin diseases, malignancy, AIDS, hypertension, and cytotoxic drugs.
It is not more than 2 hours from the time of burning up to the time of entry into the research
The patient's wound is not impregnated with contaminants
The patient did not use any substance other than drinking water on the wound before the sample entered the study
Before entering the study, the patient is not infected with different parts of the body
The patient is able to answer questions.
Exclusion criteria:
The cause of the patient's burn is chemical or electrical.
Patients who have inhaling injuries
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
33
More than 1 sample in each individual
Number of samples in each individual:
2
Both sides of symmetrical wounds, one is in the control group and the other is in the intervention group.
Randomization (investigator's opinion)
Randomized
Randomization description
First, patients are selected based on entry criteria. A random number table is used to select which hand (right or left) is in the control or intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person completing the checklist is not aware of the type of treatment has undergone. An analyst is not aware of the type of the group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.TBZMED.REC.1396.227
Health conditions studied
1
Description of health condition studied
burn wound outcomes of patients admitted
ICD-10 code
T22.6
ICD-10 code description
Corrosion of second degree of shoulder and upper limb, except wrist and hand
Primary outcomes
1
Description
burn wound healing score
Timepoint
Day one, seventh, fourteenth, twenty eight, one month later, two months later, three months later
Method of measurement
Bates-Jensen wound assessment tool
2
Description
pain
Timepoint
Day one, seventh, fourteenth, twenty eight, one month later, two months later, three months later
Method of measurement
Visual analogue scale (VAS)
3
Description
Itching
Timepoint
Day one, seventh, fourteenth, twenty eight, one month later, two months later, three months later
Method of measurement
itching Visual analogue scale (VAS)
4
Description
infection
Timepoint
Day one, seventh, fourteenth, twenty eight, one month later, two months later, three months later
Method of measurement
questionnaire
5
Description
Hypertrophy of scar
Timepoint
one month later, two months later, three months later
Method of measurement
Vancouver questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, after washing the wound with water, the Bilva ointment made in Tabnak company is used and then it is bandaged.
Category
Treatment - Drugs
2
Description
Control group: In the control group, after washing the wound with water, the routine treatment in the unit, 1% Silver sulfadiazine made in Sobhan Darou Pharmacy Company, is used and then the pomade surface is covered with one layer of Vaseline gauze to prevent its evaporation and finally it is bandaged.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Safa Tabnak
Street address
5th Floor, 10th Floor, 10th Meter Second West, First Park, North Tavanir
City
Tabriz
Province
East Azarbaijan
Postal code
5156964946
Phone
+98 41 3328 2085
Email
Tabnaktebco@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidian
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
nursing@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mojghan Lotfi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Nursery
Street address
Nursing collage, South Shariatee
City
Tabriz
Province
East Azarbaijan
Postal code
5156964946
Phone
+98 41 3328 2085
Fax
+98 41 3479 0365
Email
lotfim@tbzmed.ac.ir
Web page address
https://nursing.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Asghari
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery .Shriati Street. tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 0653
Fax
+98 41 3478 0653
Email
asghariel@tbzmed.ac.ir
Web page address
https://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Safa Tabnak
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery collage, South Shariatee
City
Tabriz
Province
East Azarbaijan
Postal code
5156964946
Phone
+98 41 3328 2085
Email
Tabnaktebco@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only the results presented by the scholar are applicable without analysis
When the data will become available and for how long
Access time 1 months after the results are published
To whom data/document is available
All faculty members of medical science universities
Under which criteria data/document could be used
Only the results presented by the scholar are applicable without analysis.
From where data/document is obtainable
Data are available upon receive of mail by the scholar. Mojgan Lotfi, 00989144130632, mlotfi@tbzmed.ac.ir
What processes are involved for a request to access data/document
The scholar will be accessible, instantly, through email and then the requested files will be sent