Evaluation of safety of hydrogel wound dressing based on polyacrylic acid and xanthan gums in patients with 2nd thickness burns (Clinical trial phase I)
Evaluation of safety of hydrogel wound dressing based on polyacrylic acid and xanthan gums in patients with 2nd thickness burns (Clinical trial phase I)
Design
A nonrandomized clinical trial (phase I), without a control group and without blinding, will be conducted on 6 volunteer patients.
Settings and conduct
The study will be performed in Velayat Hospital. 6 Men or women with second-degree Burning areas under 10% will be selected and enrolled in the study after signing a consent form. Wounds are first washed with normal saline, Then a hydrogel dressing based on polyacrylic acid and xanthan gum is placed on the wound and bandaged with sterile gauze. Before intervention and at the end of 1, 3 and, 7 days changes in burning parameters will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria are an adult patient between 18 and 65 years of age with thermal burns of less than 10% of the total body surface area. Exclusion criteria are the existence of underlying disease affecting the wound healing and the presence of electrical or chemical burns.
Intervention groups
Synthetic hydrogel based on polyacrylic acid and xanthan gum will be used as a wound dressing on the second burn degree around 10%, and then, we will investigate local and systemic outcomes in 1, 3, and 7 time intervals.
Main outcome variables
Local and systemic outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161001030072N3
Registration date:2023-05-10, 1402/02/20
Registration timing:prospective
Last update:2023-05-10, 1402/02/20
Update count:0
Registration date
2023-05-10, 1402/02/20
Registrant information
Name
Siamak Rimaz
Name of organization / entity
Guilan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8540
Email address
smkrimaz@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety of hydrogel wound dressing based on polyacrylic acid and xanthan gums in patients with 2nd thickness burns (Clinical trial phase I)
Public title
Investigation of the effect of hydrogel wound dressing based on polyacrylic acid and xanthan gum in the treatment of burn injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Thermal burns with flame or boiling water
Second degree burns
Burn percent range less than 10%
Refer to the treatment center within less than 24 hours after the burn
Normal hemoglobin and total protein levels are normal
Male or female patients in age range 18 to 65 years
Written consent form by the patients
Body mass index between 18-30 kg/m2
Exclusion criteria:
Having background diseases ( anemia, diabetes, cardiovascular diseases, immunodeficiency disorder)
Lactating women
Pregnant women
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
6
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.GUMS.REC.1402.054
Health conditions studied
1
Description of health condition studied
Second degree burn
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head, face, and neck
Primary outcomes
1
Description
Local out comes
Timepoint
At the beginning of the study (before the intervention) and 1, 3 and 7 days after applying the hydrogel wound dressing
Method of measurement
Clinical observations and filling the checklist in 4 time points
Secondary outcomes
1
Description
Systemic outcomes
Timepoint
At the beginning of the study (before the intervention) and 1, 3 and 7 days after applying the hydrogel wound dressing
Method of measurement
Clinical observations and filling the checklist in 4 time points
Intervention groups
1
Description
In the intervention group: before studying the wound, patients are examined by a doctor based on a checklist. Wounds are first washed with normal saline, Then a hydrogel dressing based on polyacrylic acid and xanthan gum (Masiha Eltiam Gostaran company) is placed on the wound and bandaged with sterile gauze. Burning parameter changes will be measured before intervention and at the end of 1, 3 and, 7 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Dr. Siamak Rimaz
Street address
3 floor, Burn and Regenerative Medicine Research Center, Velayat hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
smkrimaz@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Naghipour
Street address
Deputy of Research and Technology, Shahid Siadati Street, Namjoo Street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Mobayen
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
Maziar.mobayen@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Mobayen
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
Maziar.mobayen@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Mobayen
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
Maziar.mobayen@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