A study for evaluation of each burn dressing efficacy in Isfahan University of Medical Sciences.
Design
This study is a phase 2 clinical trial has two parallel arms, double blind and randomized by minimization method; in each group 25 patients will be evaluated.
Settings and conduct
This study is a phase 2 clinical trial with a control group and in parallel, double-blind, randomized with minimization process. There are 25 patients in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria is all of patients aged 1 to 60 years old with 2nd degree higher burn and exclusion criteria`s are anemia; pregnancy; lactation; multiple trauma and chronic disease.
Intervention groups
There are two groups in this study. Respectively we use ag-coat and amniotic membrane in first and second groups for burned wound covering.
Main outcome variables
Burn degree; burn surface; the Vancouver scar scale; hospitalization; treatment cost
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210705051792N1
Registration date:2021-11-01, 1400/08/10
Registration timing:registered_while_recruiting
Last update:2021-11-01, 1400/08/10
Update count:0
Registration date
2021-11-01, 1400/08/10
Registrant information
Name
Amin Ghanei Anaraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 7673
Email address
aminghaneei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of amniotic membrane in healing of burn wounds in comparison with Ag coat dressing in the burned patients in Isfahan burn center
Public title
The effect of amniotic membrane in compare of Agcoat in healing of burn wounds
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Second Degree or More Burn
Patient informed consent to participate in the study
In this study random sequence generation perform as minimization and for this manner initially the first case allocated to the first group and the second case also allocated to another group. According to the features of each cases a matched case also choice and include to the groups. For concealment, the cases will be added as lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before transfer to the operation room. It is explained for the patients that their burn ulcer will be dressed as one of two formal manner. In operating room after allocation of each cases to groups finally, dressing will be done. Even after surgery, the patients do not aware of dressing type. In day 7, the patients` dressing will be changed by a nurse who do not participate in the study and the patient will be refer to a researcher(who do not aware of dressing type) for evaluation of variables and these variables will be send for analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-06-25, 1400/04/04
Ethics committee reference number
IR.MUI.MED.REC.1399.736
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T30.0
ICD-10 code description
Burn of unspecified body region, unspecified degree
Primary outcomes
1
Description
The Vancouver Scar Scale
Timepoint
First week, First month, Third month, Sixth Month
Method of measurement
According to Chart and Scale between 0-13
2
Description
Hospitalization
Timepoint
From admission to discharge
Method of measurement
The days according to hospitalization file since the first day to the discharge day
3
Description
Treatment cost
Timepoint
Admission Duration
Method of measurement
Cost in Rials based on the final bill of the hospital
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group of patients, after initial resuscitation of burns, in the operating room, according to the extension of the burn, for one session or more, the burnt tissues will be debrided to reach a viable level. The burn wound will be covered by the Ag-coat dressing -Emad brand (which is the brand used by the hospital) as a standard and accepted treatment. Normally, a silver dressing is effective for 7 to 10 days, after which time it will be removed and based on the wound condition, a decision is made on how to continue the treatment, including repetition of the Ag-coat dressing, skin graft, or regular dressing. Finally, three, six and twelve months after the onset of burn, the patient's wound is evaluated according to clinical criteria as well as the Vancouver chart.
Category
Treatment - Other
2
Description
Intervention group: In this group of patients, after initial resuscitation of burns, in the operating room, based on the extension of the burn, for one session or more, the burnt tissues will be debrided to reach a viable level. The Life Cell brand (which is the brand used by the hospital) is covered as a new treatment. The amniotic dressing is usually absorbed within 5 to 7 days, after which time the condition of the wound is decided on how to continue the treatment, including skin grafts or regular dressings. Finally, three months and six months after the onset of burn, the patient's wound is evaluated according to clinical criteria as well as the Vancouver chart.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Burn Center
Full name of responsible person
Amin Ghanee Anaraki
Street address
Isfahan Burn Center, Kave Ave.
City
Isfahan
Province
Isfehan
Postal code
8138894948
Phone
+98 31 3345 7670
Fax
+98 31 3345 8803
Email
info@savaneh.mui.ac.ir
Web page address
https://savaneh.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara Arti
Street address
Esfahan University of Medical Sciences, Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3061
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amin Ghanee Anaraki
Position
Plastic Surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Plastic Surgery
Street address
Second Floor, Savaneh hospital, Kave
City
Isfahan
Province
Isfehan
Postal code
8138894948
Phone
+98 31 3345 7670
Email
aminghaneei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Kalbasi Gharavi
Position
Plastic Surgery Fellowship
Latest degree
Specialist
Other areas of specialty/work
Plastic Surgery
Street address
Second Floor, Savaneh hospital, Kave
City
Isfahan
Province
Isfehan
Postal code
8138894948
Phone
+98 31 3345 7670
Email
kalbasimajid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Kalbasi Gharavi
Position
Plastic Surgery Fellowship
Latest degree
Specialist
Other areas of specialty/work
Plastic Surgery
Street address
Second Floor, Savaneh hospital, Kave
City
Isfahan
Province
Isfehan
Postal code
8138894948
Phone
+98 31 3345 7670
Email
kalbasimajid@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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Title and more details about the data/document
Except of Personal Information of patients all of other is reachable
When the data will become available and for how long
Every 3 months
To whom data/document is available
Academic Researcher
Under which criteria data/document could be used
Academic Research
From where data/document is obtainable
Study Correspondent
What processes are involved for a request to access data/document