The objective of this study is extraction of beta glucan from cell wall of fungi and using in cream form for wound healing in burn patients.
The efficacy of this product in cream form will be evaluated during debridement and changing the dressing of wound.
This Randomised clinical trial(phase 3) study will performed during 20 months in 124 patients with level 2 burn wound in .
Care monitoring comprising closing and decreasing the wound size in first week of care,the third day and end of second week and finally end of treatment. Histopathology examination will perform for confirm of wound healing with preparation section from wound area,tissue staining and assessment tissue changing with light microscope.Also for estimating macrophage activity that play main role in wound healing,the end of treatment period in each group of patient (control and test),2-4 ml blood sample will collect the serum separate and inflammatory cytokine such as TNFα ,IFNγ ,IL1 assess by using ELISA kit and OD in control and test group will determine using ELISA reader.
inclusion criteria are;the age of patients:18-50 years.burn classification: level 2 and <50% of body surface is burned.Gender;two gender(male , famale)
Exclusion criteria: The women with pregnancy; the patients with immunodeficiency ;Liver and Kidney diseases.
The patients including control and test groups.Treatment with local form of beta glucan continued at 8 week in test group.Although the two group receive silver sulfadiazine as base line care
Primary outcome is Decrease at least 25% wound surface.Secondry outcome are measurement of INFγ ,IL1,TNFα .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020726411N1
Registration date:2016-03-14, 1394/12/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-14, 1394/12/24
Registrant information
Name
Maryam Roudbary
Name of organization / entity
Iran ,University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 3296
Email address
roudbari.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ministry of research and Technology,Iran University of Medical Science
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
assesment of immunmodulatory effect of β Glucan on wound healing ,A two parallel group randomized clinical trial
Public title
assesment of immunmodulatory effect of β Glucan on wound healing in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
According the similar studies in wound healing by using other imperious agents and attitude skin healing physician in motahari hospital, in this study inclusion criteria are;the age of patients:18-50 years.burn classification: second level and <50% of body surface is burned.Gender;two gender(male , famale)
Exclusion criteria: the women with pregnancy; the patients with immunodeficiency, immunosuppression drug consumption; acute infections ;Liver and Kidney diseases .The pateints don’t permit to enter the other clinical trial during this study.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
According Block Randomization and regarding 4 blocks,31 block will produce for 124 patients
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemat west highway,intervention shikh fazollah nori and chamran
City
Tehran
Postal code
Approval date
2015-10-07, 1394/07/15
Ethics committee reference number
IR.IUMS.REC.1394 - 26610
Health conditions studied
1
Description of health condition studied
Burn wound
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Burn wound
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Decrease at least 25% wound surface
Timepoint
decreasing the wound size in first week of care,the third day and end of second week and finally end of treatment
Method of measurement
centimeter
Secondary outcomes
1
Description
TNF Alpha
Timepoint
End of study(8th week)
Method of measurement
ELISA and OD
2
Description
IFN gamma
Timepoint
End of study(8th week)
Method of measurement
ELISA and OD
3
Description
IL1
Timepoint
End of study(8th week)
Method of measurement
ELISA and OD
Intervention groups
1
Description
The patients divide two groups: The first one is control group that receive the usual wound care protocol (silver sulfadiazine)
Category
Treatment - Drugs
2
Description
The second group comprising patients that receive extracted beta Glucan in local form plus silver ointment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Maryam Roudbary
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ministry of Research and Technology Iran University of Medical Science
Full name of responsible person
Dr seyed Ali Javad Mosavi
Street address
Hemat Highway,intervention shikh Fazollah and chamran,Iran University of Medical science,Ministry of research
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ministry of Research and Technology Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran university of Medical science
Full name of responsible person
Dr Maryam Roudbary
Position
Assistant Professor
Other areas of specialty/work
Street address
school of Medicine,Department of Mycology and parasitology
City
Tehran
Postal code
Phone
+98 21 8670 3296
Fax
+98 21 8862 2532
Email
m_roudbary@yahoo.comroudbari.mr@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine,Iran university of medical science,Tehran,iran
Full name of responsible person
Maryam Roudbary
Position
PhD of Medical Mycology
Other areas of specialty/work
Street address
Hemmat west Highway,Intervention shikh Fazlollah and Chamran,Iran University Of Medical Science
City
Tehran
Postal code
Phone
+98 21 8670 1108
Fax
Email
m_roudbary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Shahla roudbar Mohammadi
Position
Associate professor
Other areas of specialty/work
Street address
School of Medical science,Department of Mycology
City
Tehran
Postal code
Phone
+98 21 8288 4540
Fax
+98 55622532
Email
sh.mohammadi@modares.acir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)