Effect of probiotic ointment on prevention and control of infection, wound healing and shortening wound healing time
Design
Clinical trial with control group, with parallel groups, Non-random assignment to intervention and control groups was not blinded
Settings and conduct
Twenty patients from Motahhari burn hospital in Tehran were divided into two groups (control group) and experimental group.
(Recipient of probiotic product) will be selected. The control group will receive Silver Sulfadiazine ointment and the experimental group will receive Lactobacillus plantarum ointment for one week.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with grade II superficial burn wounds without other secondary diseases
Exclusion criteria: Patients with deep grade II burns, grade III and IV, as well as patients with superficial grade II burns who have concomitant kidney disease, hypertension, or secondary infection.
Intervention groups
Intervention group: Includes patients with grade II burn wounds who receive treatment with probiotic product.
Intervention group (control): Includes patients with grade II burn wounds who receive routine antibiotic treatment.
Main outcome variables
Burn wound healing
Prevention of burn infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191011045055N1
Registration date:2019-11-13, 1398/08/22
Registration timing:prospective
Last update:2019-11-13, 1398/08/22
Update count:0
Registration date
2019-11-13, 1398/08/22
Registrant information
Name
Maryam Roham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2397
Email address
roham.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of probiotic Lactobacillus plantarum with common treatment in the preventive of infection and wound healing
Public title
the survey of effect of probiotic on wound healing in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
(deep second-degree) burn and (Superficial three-degree) burn with a percentage below 20% and no primary infection
Exclusion criteria:
Age of under 10 and over 65 due to weak immune system
Diabetes, hypertension, kidney and seizures disease
Use of antibiotics during treatment
Other infections (except burns)
Age
From 10 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
the side of right and left of body
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Anti-Microbial Resistance Research center, Institute of Immunology and Infectious Diseases, Rasole hospital, Niayesh st, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
123
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.614
Health conditions studied
1
Description of health condition studied
Infection and scar of burn wound
ICD-10 code
M61.30
ICD-10 code description
Calcification and ossification of muscles associated with burns, unspecified site
Primary outcomes
1
Description
Percentage of people with burn wound healing
Timepoint
The study will start (at the time of topical treatment) and the duration of treatment will be 7 days.
Method of measurement
Wound culture-Morphological observation of wounds
Secondary outcomes
1
Description
Prevention of infection after discharge from hospital
Timepoint
Two weeks after discharge
Method of measurement
diagnosis of Infectious disease specialist
Intervention groups
1
Description
Control group:Routine treatment group with antibiotics
Category
Treatment - Drugs
2
Description
Intervention group: Group receiving the probiotic product
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
dr Mehnoosh Momeni
Street address
Motahari Hospital, Rashid Yasemi St, Vanak
City
Tehran
Province
Tehran
Postal code
123
Phone
+98 21 6435 2397
Email
so.soleymanzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
dr. Seyed Abas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
tehran
Province
Tehran
Postal code
123
Phone
+98 21 6435 2397
Email
so.soleymanzadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
somayeh soleymanzadeh moghadam
Position
Laboratory expert and Executive Director of the Anti-Microbial Resistance Research Center
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Anti-Microbial Resistance Research center, Institute of Immunology and Infectious Diseases, Rasole hospital, Niayesh st , Sattarkhan St,
City
tehran
Province
Tehran
Postal code
123
Phone
+98 21 6435 2397
Email
so.soleymanzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
dr. Maryam Roham
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Anti-Microbial Resistance Research center,Institute of Immunology and Infectious Diseases,Rasole hospital, Niayesh st, Sattarkhan St,
City
Tehran
Province
Tehran
Postal code
123
Phone
+98 21 6435 2397
Email
so.soleymanzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
somayeh soleymanzadeh moghadam
Position
کارشناس و مسئول اجرایی مرکز تحقیقات مقاومت های میکروبی
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Sattarkhan St,Niayesh st,Rasole hospital, Institute of Immunology and Infectious Diseases, Anti-Microbial Resistance Research center
City
Tehran
Province
Tehran
Postal code
123
Phone
+98 21 6435 2397
Email
so.soleymanzadeh@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Drug efficacy report after completion of the treatment process will be presented
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Academic and industrial people
Under which criteria data/document could be used
Provided for use in the article with citing the source
From where data/document is obtainable
021-64352397
What processes are involved for a request to access data/document
After the clinical phase is completed, statistical analysis will be performed on the data and some of it will be shared after verification and .