Characterization and evaluation of the effectiveness of Hiligel hydrogel wound dressing on 2A degree burns
Design
Clinical trial with a control group, with parallel groups, without blinding, randomized, phase 1 on 20 patients. For randomization, the RAND function of Excel software was used.
Settings and conduct
Patients with 2A degree burn wounds on the forearm or leg are referred to Shahid Motahari Burn Hospital. Informed consent is obtained from them before starting the treatment. Patients are included in the study if they meet the criteria for entering the plan. 20 patients will be admitted and randomly divided into two groups. In this study, duration of treatment in terms of days, rate of complete wound closure, wound size reduction of more than 50% and treatment costs will be evaluated in both groups of treated with hydrogel wound dressing and standard treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women aged 20 to 50 years with 2A degree burns Exclusion criteria: The person has infections and underlying diseases and immune system deficiency. The wound is in the face and genital area.
Intervention groups
Patients are divided into two intervention and control groups of 10 people; the intervention group is dressed with hydrogel wound dressing, and the control group is dressed with 1% silver sulfadiazine ointment.
Main outcome variables
Wound size; Wound healing rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240617062158N2
Registration date:2024-07-11, 1403/04/21
Registration timing:registered_while_recruiting
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Hamed Daemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7625 1069
Email address
h.daemi@ippi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of safety and efficacy of hydrogel wound dressing in treatment of burn wounds (Hiligel)
Public title
Hiligel hydrogel wound dressing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of 2A degree burns in the upper limbs such as both hands
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
According to the time of entry for each patient into the research, the patients are placed in one of two groups in such a way that the first patient enters the first group, the second patient enters the second group, the third patient enters the first group and so on. The first group is treated with the wound dressing and the second group received the standard treatment.
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 Research Institute for Oncology, Hematology and Cell Therapy - Tehran University
Street address
Research Institute for Oncology, Hematology & Cell Therapy, Shariati Hospital, North Kargar, Tehran
City
Tehran
Province
Tehran
Postal code
13135-14117
Approval date
2024-06-11, 1403/03/22
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1403.013
Health conditions studied
1
Description of health condition studied
2A degree burn wound
ICD-10 code
T25.2
ICD-10 code description
Burn of second degree of ankle and foot
Primary outcomes
1
Description
Wound size
Timepoint
At the beginning of the study and 7 and 14 days after the treatment
Method of measurement
Imaging and measuring the area of the remaining wound by the software
2
Description
Percentage of healing in patients according to the type of treatment
Timepoint
At the beginning of the study and 7 and 14 days after the treatment
Method of measurement
Statistics calculations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treated with the Hiligel hydrogel dressing to the wound bed (0.5 mL per square centimeter) in grade 2A burn wounds that is bandaged every other day for up to 14 days.
Category
Treatment - Other
2
Description
Control group: Treated with silver sulfadiazine ointment (1%) that is bandaged every other day for up to 14 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Burn Center
Full name of responsible person
Mostafa Dahmardehei
Street address
Motahari Hospital, Rashid Yasemi St, Vanak Sq, Vali-e-Asr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1996714353
Phone
+98 21 8877 0031
Email
motahari.hos@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari sari
Street address
Research and Technology Deputy, 6th floor, Quds St, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
20
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
2
Sponsor
Name of organization / entity
Zharfandishan Fanavar Zistbaspar
Full name of responsible person
Hamed Daemi
Street address
Islamic Azad University North Branch, Bahar Blvd, Chamanara Blvd, Hakimiyeh
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7625 1069
Email
ham.daemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zharfandishan Fanavar Zistbaspar
Proportion provided by this source
80
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Zharfandishan Fanavar Zistbaspar
Full name of responsible person
Maryam Zare
Position
Technical Supervisor
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
Islamic Azad University North Branch, Bahar Blvd, Chamanara Blvd, Hakimiyeh
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 2248 5514
Email
zmary1392@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zharfandishan Fanavar Zistbaspar
Full name of responsible person
Hamed Daemi
Position
Assistante Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Islamic Azad University North Branch, Bahar Blvd, Chamanara Blvd, Hakimiyeh
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7625 1069
Email
ham.daemi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zharfandishan Fanavar Zistbaspar
Full name of responsible person
Maryam Zare
Position
Technical Supervisor
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
Islamic Azad University North Branch, Bahar Blvd, Chamanara Blvd, Hakimiyeh
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 2248 5514
Email
zmary1392@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 9 months after the publishing the results
To whom data/document is available
Academic staff
Under which criteria data/document could be used
After agreement of volunteer patient and executive team
From where data/document is obtainable
Principal investigator
What processes are involved for a request to access data/document
After agreement of volunteer patient and executive team