A comparative study on the efficacy and safety of temporary cover wound dressing with Agi coat in comparison with allograft (cadaver) in burn patients admitted to Imam Musa Kazem Hospital in Esfahan.
Comparison of efficacy and safety of temporary burn wound dressing with Ajicoat compared to allograft
Design
Patients were divided into two groups (25 people in each group) control (dressing with ajikot) and experimental group (dressing with cadaver). The sampling method was that the first sample entered in the study was placed in the experimental group and the next sample in the control group. Did we
Settings and conduct
This clinical trial was performed after approval by the ethics committee of Isfahan University of Medical Sciences and receiving permission and obtaining written consent from patients. In order to conduct the research, the researcher first referred to Imam Musa Kazem (AS) Hospital with a written letter of introduction from the research deputy and after explaining the process and objectives of the research, attracted the cooperation of the officials. This study is a clinical trial and prospective. In total, 50 burn patients who met the inclusion criteria were included in this study after filling out the consent form.
Participants/Inclusion and exclusion criteria
Patients in the age group of 18-45 years with 20-30% burns and deep grade 2 and 3 were identified. These patients had at least 12 mg per 100 cc and serum protein at least 6 mg per 100 cc at baseline
Intervention groups
جهت پانسمان گروه کنترل از اجی کوت و گروه آزمون از کاداور استفاده شد که نحوه درمان بدین صورت بود که در اتاق عمل پس از دبریدمان، روی زخمها با اجی کوت یا کاداور که در گلیسرول 85% بود، پوشانده شد و قبل از استفاده از کاداور آن را بمدت 10 دقیقه با نرمال سالین شستشو داده تا غلظت گلیسیرین موجود در آن به کمتر از 1% برسد.
Main outcome variables
Wound infection rate,Debridement rate،The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190807044468N1
Registration date:2020-11-19, 1399/08/29
Registration timing:retrospective
Last update:2020-11-19, 1399/08/29
Update count:0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
fateme hadadi sohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 7672
Email address
hadadesoh94@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-08, 1397/05/17
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
2018-08-08, 1397/05/17
Actual recruitment end date
2019-12-01, 1398/09/10
Trial completion date
2019-12-01, 1398/09/10
Scientific title
A comparative study on the efficacy and safety of temporary cover wound dressing with Agi coat in comparison with allograft (cadaver) in burn patients admitted to Imam Musa Kazem Hospital in Esfahan.
Public title
The effect of ajicoat and cadaver on burn treatment
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age group of 18-45 years with 20-30% burns and deep grade 2 and 3 were identified.
These patients had at least 12 mg per 100 cc and serum protein at least 6 mg per 100 cc at baseline
Exclusion criteria:
More than 48 hours had passed since their burns.
Age
From 18 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
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 Esfahan University of medical Sciences
Street address
Kaveh AveImam Musa Kazem Hospital in Esfahan.,
City
Esfahan
Province
Isfehan
Postal code
81388-94999
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.198
Health conditions studied
1
Description of health condition studied
burn and corrosion
ICD-10 code
T31.2
ICD-10 code description
Burns involving 20-29% of body surface
Primary outcomes
1
Description
Wound debridement rate
Timepoint
Measure pain and debridment and infection from day one to day thirteen
Method of measurement
To collect samples, a checklist was used which consisted of two parts: the first part was related to patients' demographic information including age, sex, date and time of burn, depth and percentage of burn. The second section included information on morphine use, number of debridement surgeries, the patient's pain score in the postoperative days, and symptoms of wound infection.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For dressing the experimental group, cadaver was used. The treatment method was that in the operating room after debridement, the wounds were covered with cadaver, which was 85% glycerol and prepared from Iranian Tissue Products Company. Using Kadavar, rinse it with normal saline for 10 minutes to reduce the glycerin concentration to less than 1%. Serum tests for CMV-Ab: VDRL: HCV-Ag: HBS-Ag have been performed and approved for allografts. It is the Ministry of Health, and it is also made in Iran.
Category
Treatment - Surgery
2
Description
Control group: Agicoat was used for dressing the control group, which was treated in such a way that in the operating room, after debridement, the wounds were covered with Agi coat prepared by Sara Pars Pharmaceutical Company.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences-Imam Musa Kazem Hospital
Full name of responsible person
Fateme Hadadi Sohi
Street address
Kaveh St. - Imam Musa Kazem Hospital
City
Esfahan
Province
Isfehan
Postal code
81388-94999
Phone
+98 31 3345 7672
Email
hadadesoh94@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences.Vice-Chancellery for Research & Technology
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.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
Fateme Hadadi Sohi
Position
Infection Control Expert
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kaveh St. - Imam Musa Kazem Hospital
City
Esfahan
Province
Isfehan
Postal code
81388-94999
Phone
+98 31 3345 7672
Email
hadadesoh94@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Hadadi Sohi
Position
Infection Control Expert
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kaveh St. - Imam Musa Kazem Hospital
City
Esfahan
Province
Isfehan
Postal code
81388-94999
Phone
+98 31 3345 7672
Email
hadadesoh94@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Hadadi Sohi
Position
Infection Control Expert
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kaveh St. - Imam Musa Kazem Hospital
City
Esfahan
Province
Isfehan
Postal code
81388-94999
Phone
+98 31 3345 7672
Email
hadadesoh94@yahoo.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
No - There is not a plan to make this available
Title and more details about the data/document
Data on main outcomes
When the data will become available and for how long
2020
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
For research
From where data/document is obtainable
Message to email
What processes are involved for a request to access data/document