Comparison of the effects of biological (amniotic) with traditional dressings in the treatment of deep second degree burn wounds 5-20% in less than 24 hours in patients admitted to the Velayat hospital
Comparison of the effect of biological dressings (amniotic fluid) with traditional dressings in the treatment of second-degree thermal burn wounds of less than 24 hours 5 - 20% in patients referred to the burn hospital of the province.
Design
In this study, to assign patients to intervention and control groups, the Restricted randomization approach will be used in parallel with the random block method. We will consider blocks of random size of 4.
Random Allocation software will be used to generate random numbers.
In this study, blinding will not occur due to the different appearance of biological (amniotic) and traditional dressings.
Settings and conduct
In this study, to compare the effect of biological dressings (amniotic fluid) with traditional dressings in treating burn wounds less than 24 hours, second-degree depth of 5-20% in patients referred to the provincial hospital, all eligible patients will be included in the study. In this study, blinding will not occur due to the different appearance of biological (amniotic) and traditional dressings.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Satisfaction with participation in the study
• Age 18 to 60 years
• Grade 2 burns with 5-20%
• No grade 3 burns
• Admission less than 24 hours from the occurrence of burns
• Heat burns with boiling water or flammable materials
• No underlying diseases
Exclusion criteria:
• Death of the patient
• Dissatisfaction with continuing the study
• Impossibility to follow the patient treatment process
Intervention groups
Intervention group 1: biological dressings (amniotic fluid) and group 2: traditional dressings
Main outcome variables
Pain rate; Itching rate; Average number of dressings; Incidence of infection; Duration of hospitalization; recovery time in days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210524051384N1
Registration date:2021-08-24, 1400/06/02
Registration timing:prospective
Last update:2021-08-24, 1400/06/02
Update count:0
Registration date
2021-08-24, 1400/06/02
Registrant information
Name
mohammadreza mobayen
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8540
Email address
maziar.mobayen@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of biological (amniotic) with traditional dressings in the treatment of deep second degree burn wounds 5-20% in less than 24 hours in patients admitted to the Velayat hospital
Public title
Comparison of the effects of biological (amniotic) with traditional dressings in the treatment of deep second degree burn wounds 5-20% in less than 24 hours in patients admitted to the Velayat hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Grade 2 burns
Burns that are greater than 20 to 25 percent
Admission less than 24 hours from the occurrence of burns
Thermal burns with boiling water or flammable substances
No underlying diseases such as diabetes, immune system deficiency, connective tissue disease, kidney disease, liver disease and hepatitis, etc.
Satisfaction of participating in the study
Exclusion criteria:
Age over 60 years
Patients who died during the study
Dissatisfaction with continuing the study
Impossibility to follow the patient treatment process
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking and allocation sequences will be done by the person not involved in the research to hide the patient's choice. The sample allocation ratio will be (1: 1) and will be divided into control and intervention groups. Then, based on the obtained blocks and in the order of allocation, the dressings will be placed on the patients of the control and intervention groups. In this study, blinding will not occur due to the different appearance of biological (amniotic) and traditional dressings. In this study, to assign patients to intervention and control groups, the limited randomization approach will be used in parallel with the block randomization method. We will consider random blocks of size 4.
A table of random numbers (Random allocation software ) will be used to generate random numbers.
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
Research Ethics Committees Of Guilan University Of Medical Sciences
Street address
Guilan University Of Medical Science
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2021-07-28, 1400/05/06
Ethics committee reference number
IR.GUMS.REC.1400.177
Health conditions studied
1
Description of health condition studied
Acute burn
ICD-10 code
T30
ICD-10 code description
Burn and Corrosion, Body Region Unspecified
Primary outcomes
1
Description
Average recovery time
Timepoint
daily
Method of measurement
Based on disease course / percentage
Secondary outcomes
empty
Intervention groups
1
Description
biological dressing: For patients with grade 2 burns, in group A, after cleaning the burned surface and removing blisters and foreign objects from the burn site, washing with normal saline will be performed, and then biological dressing (amniotic fluid) will be served. The amniotic biological dressing is prepared from a pair of healthy mothers after a selective cesarean section at Al-Zahra Hospital. According to health protocols for mothers, blood samples are sent to the laboratory for testing for HCV, HBS, and HIV. The embryonic-related layers of the placenta are separated under the hood and then washed under sterile conditions with Ringer's solution. The amniotic layer is separated and transferred to cold sterilized containers (4 ° C). to remove the blood and other contaminants, it will be washed four times with normal saline. Once with 0.25% sodium hypochlorite solution, and washed again with normal saline. Then, the samples are transferred to sterile containers and refrigerated. When placing the amniotic membrane, care should be taken; that the underlying layers, which can reproduce, should be placed on the wound.
Category
Treatment - Other
2
Description
B) Traditional dressings: In group B, dressings will be applied in a traditional and daily manner according to the protocol of the Velayat hospital. After washing the wound with normal saline and debridement if necessary, ointments (Flamazine, Adiazine ،Mafenaide, Sulfamylon) are applied to the wound and then with plain gas. Will be covered and dressed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Amirmohammad Gholipour
Street address
Velayat Hospital, Namjoo St. , Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8633
Email
velayathospital@gmail.com
Web page address
https://www.gums.ac.ir/velayat
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Guilan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Naghipour
Street address
Namjoo St, in front of 17 Shahrivar Hospital, Deputy of Research and Technology, Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellor for Research, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Ammirmohammad Gholipour
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Velayat Hospital, Namjoo St, Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8860
Email
Velayathospital@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan university of Medical Sciences
Full name of responsible person
Dr Mohammadreza Mobayen
Position
Specialist In General Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namjoo St, Velayat Hospital, Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8860
Email
Maziar.mobayen@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Amirmohammad Ghoulipour
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Public Health
Street address
Velayat Hospital, Namjoo St. , Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8860
Email
velayathospital@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
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
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
Undecided - It is not yet known if there will be a plan to make this available