The Effect of Adding Combination of Kefir and Malva sylvestris to Silver Sulfadiazine on Healing Time and Infection Rate in Second-degree Burning: Randomized Controlled Clinical Trial
Study of combination of Kefir and Malva Sylvestris on time of care and infection rate of second-degree burning:
Design
Randomized clinical trial with control group, Parallel groups, double blinded, sample size is 70
Settings and conduct
The study will be conducted in Maragheh and Tabriz hospitals. The ointments are packaged in completely similar packages as ointment A and B, and patients are randomly assigned to receive supplements. The patient will use ointment for dressing burn area with the same type of ointment. In addition to nurse care, every 3-4 days the patient will be examined by another researcher for the presence of burn infection and the rate of recovery. Patients, medical staff, and statistical analyzer are not aware of medications.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Heat burn; Second-degree Burn; Wound area below 10%.
Non inclusion criteria: burn occurred more than 6 hours; Age under 12 years old; burns grade 1 or grade 3 and above; Chronic diseases such as cancer or diabetes
Intervention groups
Intervention group: will receive standard treatment plus new kefir and Malva sylvestris 10% ointment. Control group: Only receive standard burn treatment that includes silver sulfadiazine ointment.
Main outcome variables
Burn healing time; Infection status; Burn scar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120112008712N3
Registration date:2019-10-31, 1398/08/09
Registration timing:registered_while_recruiting
Last update:2019-10-31, 1398/08/09
Update count:0
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
Mojtaba Ziaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3725 6920
Email address
ziaee.m@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-01, 1398/07/09
Expected recruitment end date
2020-08-01, 1399/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Adding Combination of Kefir and Malva sylvestris to Silver Sulfadiazine on Healing Time and Infection Rate in Second-degree Burning: Randomized Controlled Clinical Trial
Public title
Kefir and Malva sylvestris in treatment of burning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2nd Degree Burning
Heat Burning
Burning area under 10%
Exclusion criteria:
Over 6 hours of burning time
Age under 12 years old
1st degree burning or higher than 2nd degree
Chemical or Electrical Burning
Hypersensitivity to milk compounds, or combinations of drugs or dressing; Comorbidity.
Pregnancy or breastfeeding
People under chemotherapy or immunosuppressive drugs
Hemoglobin and total protein are less than normal.
The patient's wound is impregnated with contaminating material.
Burn in the facial and genital areas
Diabetic Patients
Age
From 12 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
35
2 groups: Kefir and Malva sylvestris combination versus only Silver Sulfadiazine Groups
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization with computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
َAll Patients, nurses, and doctors, as well as statistical analyzers, will be unaware of the treatment codes
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Maragheh University of Medical Sciences
Street address
North Moallem St., Maragheh, East Azerbaijan, Iran
City
Maragheh
Province
East Azarbaijan
Postal code
5518578151
Approval date
2019-06-13, 1398/03/23
Ethics committee reference number
IR.MARAGHEHPHC.REC.1398.011
Health conditions studied
1
Description of health condition studied
Burn of second degree
ICD-10 code
T29.2
ICD-10 code description
Burns of multiple regions, no more than second-degree burns mentioned
Primary outcomes
1
Description
Percentage of burn wounds area
Timepoint
Area of wound at the beginning of the study (before the intervention) and on 3, 7 and 14 days, and then every 15 days until complete recovery
Method of measurement
Using a digital camera, the shot will be taken from the pre-dressing stage from 15 cm distance, and the area of the wound will be estimated using the AutoCAD software from the wound images.
Secondary outcomes
1
Description
Infection
Timepoint
Third, Seventh, Fourteenth and completed healing days
Method of measurement
microbial culture
2
Description
wound Scare
Timepoint
Third, Seventh, Fourteenth and completed healing days
Method of measurement
Digital Photography
Intervention groups
1
Description
In the control group: Before examining the wound, patients are examined by a physician based on a standard checklist. Then the limb or the burned area is washed with normal saline and dried by sterile gas. Silver sulfadiazine 1% ointment would be applied with sterile gloves on the wound. In this study, wound healing would be evaluated on days 1, 3, 7 and 14 after-burn.
Category
Treatment - Other
2
Description
In the intervention group: Before examining the wound, patients will be examined by a physician, based on a checklist. After washing and drying the burned tissue, kefir ointment and 10% extract of Malva sylvestris is applied to the wound area. Silver sulfadiazine 1% ointment is then applied and the wound will be dressed. In this study, wound healing would be evaluated on days 1, 3, 7 and 14 after-burn.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Gholamreza Farid Alaei
Street address
North Moallem St., Maragheh, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5515878151
Phone
+98 41 3725 6920
Email
grf.aalae@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Maragheh University of Medical Sciences
Full name of responsible person
Gholamreza Farid Alaaei
Street address
North Mollem
City
Maragheh
Province
East Azarbaijan
Postal code
5515878151
Phone
+98 41 3725 6920
Email
ghf.alaaei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maragheh 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
Maragheh University of Medical Sciences
Full name of responsible person
Gholamreza Farid alaaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
North Moallem
City
Maragheh
Province
East Azarbaijan
Postal code
5515878151
Phone
+98 41 3725 6920
Email
ghf.alaaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Maragheh University of Medical Sciences
Full name of responsible person
Mojtaba Ziaee
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
North Moallem
City
Tabriz
Province
East Azarbaijan
Postal code
5515878151
Phone
+98 41 3725 6930
Email
mjziaee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Maragheh University of Medical Sciences
Full name of responsible person
Mojtaba Ziaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Maragheh University of Medical Sciences
City
Maragheh
Province
East Azarbaijan
Postal code
5515878151
Phone
+98 41 3725 6920
Fax
+98 41 3725 6919
Email
mjziaee@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
There is not more information
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document