Comparison of the advantages of the amnion (biological dressing ) + silver sulafadiazine standard dressings in treatment of acute burn wounds of the second deep burn and third degree
Comparison of the advantages of amnion silvrasufadiazin with standard dreasing
Design
Randomized, clinical trial on two groups, blinded, conducted on 50 patients
Settings and conduct
A blinded study will be conducted on patients with the second deep and third burn degree in Ahvaz Taleghani Hospital. The dressing is changed in the operation room
Participants/Inclusion and exclusion criteria
Patient whit the second deep burn and third degree
Intervention groups
One group will be dressed with Amnion membran and silver cream , the other group will be dressed with silver
Main outcome variables
Age; sex; number of dressing changes; duration of preparation for graft; number of dressing changes;the effectiveness of two methods; checking the amount of use opium
General information
Reason for update
Acronym
CAA
IRCT registration information
IRCT registration number:IRCT20231202060240N1
Registration date:2024-03-02, 1402/12/12
Registration timing:retrospective
Last update:2024-03-02, 1402/12/12
Update count:0
Registration date
2024-03-02, 1402/12/12
Registrant information
Name
Ali Nazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 9843
Email address
dr.alinazeri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-28, 1402/08/06
Expected recruitment end date
2024-01-27, 1402/11/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the advantages of the amnion (biological dressing ) + silver sulafadiazine standard dressings in treatment of acute burn wounds of the second deep burn and third degree
Public title
Effect of Amnion dressing in healing of burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient whit acute burn wounds of the second and third
Exclusion criteria:
Electrical burn
Age
From 1 year old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient does not know the type of dressing
Placebo
Not used
Assignment
Parallel
Other design features
None
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Hejrat Blvd, Padadshahr, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Approval date
2023-10-28, 1402/08/06
Ethics committee reference number
IR.AJUMS.REC.1402.392
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T31
ICD-10 code description
Burns classified according to extent of body surface involved
Primary outcomes
1
Description
Amount of opium
Timepoint
At the time of dressing change
Method of measurement
Milligram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: adding amnion membrance to standard dressing that will be changed every three days.
Category
Treatment - Surgery
2
Description
Control group: standard dressing. Silversulfadiazin 1% is used in this group that will be changed every day .
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Rahbar
Street address
Hejrat Blvd, Padadshahr, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61867954386
Phone
+98 61 3311 3943
Fax
+98 61 3311 3943
Email
dr.alinazeri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Rahbar
Street address
Hejat Blvd, Padadshahr,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3311 3943
Fax
+98 61 3311 3943
Email
dr.alinazeri@gmail.com
Grant name
Ahvaz University of Medical Sciences
Grant code / Reference number
ندارد
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Nazeri
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hejrat Blvd, Padadshahr, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3311 3934
Fax
+98 61 3311 3934
Email
dr.alinazeri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Nazeri
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hejrat Blvd, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
618794386
Phone
+98 61 3311 3943
Email
dr.alinazeri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Nazeri
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hejrat Blvd, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
618754386
Phone
+98 61 3311 3984
Email
dr.alinazeri@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
All information can be shared
When the data will become available and for how long
Four months after publication
To whom data/document is available
Everyone
Under which criteria data/document could be used
Treatment of burnt patient
From where data/document is obtainable
My Email address
What processes are involved for a request to access data/document