Characterization and evaluation of the safety and effectiveness of human umbilical cord blood serum alginate hydrogel on patients with 2A degree burns(Phase 1 clinical trial)
Characterization and evaluation of the effectiveness of umbilical cord blood serum alginate hydrogel on 2A degree burns
Design
This study is a phase 1 clinical trial, in which 30 qualified 2A degree burn wound samples from patients of Motahari Hospital were selected as research samples and randomly and without blinding were divided into two intervention and control groups of 15 people. The intervention group was treated with umbilical cord blood serum alginate hydrogel with a diameter of 5 mm on the burn wound, and the control group was treated with a layer of 1% silver sulfadiazine ointment along with a simple hydrogel dressing every other day for 14 days. At the arrival of the patient before the study and during the treatment on the 7th and 14th days, the speed of wound healing with Image J software and checking the amount of scar is the amount of pain reduction in the follow-up visits with photos and analysis and a questionnaire
Settings and conduct
The intervention group will be treated with umbilical cord blood serum alginate hydrogel with a diameter of 5 mm on the intended burn wound and the control group will be treated with a layer of 1% silver sulfadiazine ointment along with a simple hydrogel wound dressing every other day for 14 days in Motahari Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: men and women aged 18 to 60 years with 2A degree burns
Exclusion criteria: the person has underlying infections and diseases and immune system deficiency. The wound is in the face and genital area
Intervention groups
The patients are divided into two intervention and control groups of 15 people, the intervention group is dressed with umbilical cord blood serum alginate hydrogel and the control group is dressed with 1% silver sulfadiazine ointment along with a simple hydrogel dressing
Main outcome variables
Healing time; scar rate; The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221130056672N3
Registration date:2024-01-10, 1402/10/20
Registration timing:prospective
Last update:2024-01-10, 1402/10/20
Update count:0
Registration date
2024-01-10, 1402/10/20
Registrant information
Name
EHSAN Taghiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7541
Email address
etaghiabadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Characterization and evaluation of the safety and effectiveness of human umbilical cord blood serum alginate hydrogel on patients with 2A degree burns(Phase 1 clinical trial)
Public title
Characterization and evaluation of the safety and effectiveness of human umbilical cord blood serum alginate hydrogel on patients with 2A degree burns.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women aged 18 to 60 who have 2A degree burns with a burn percentage of less than 15% of the body surface.
The dimensions of the burn wound should be 10 x 10 cm.
Willingness to participate in research and able to answer questions.
Exclusion criteria:
Have underlying diseases and immune system defects such as diabetes, cancer, AIDS, high blood pressure and skin allergies.
Before entering the sample into the research, they have used a substance other than drinking water on the wound.
A person with symptomatic infection in different parts of the body.
Burns in the face and genital area.
More than 48 hours have passed from the time of the burn to the time of entering the study.
According to the doctor's opinion, the person needs to be hospitalized.
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple randomization method, patients who come to Motahari Hospital with 2A degree burns are placed in 2 groups of 15 people, so that one envelope is randomly selected for each patient from the number of 30 sealed envelopes. The letters A and B are inserted inside each envelope. Group A patients will be treated with 1% silver sulfadiazine ointment and group B will be treated with cord blood serum alginate hydrogel.
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 Research Institute for Oncology, Hematology and Cell Therapy - Tehran
Street address
Shariati Hospital, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2023-12-13, 1402/09/22
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1402.053
Health conditions studied
1
Description of health condition studied
2A degree burns
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Healing time
Timepoint
Measurement of healing time on days 0 (before the intervention), 7 and 14
Method of measurement
Photography with Image J software
Secondary outcomes
1
Description
The amount of pain
Timepoint
Pain measurement on days 0 (before the start of the intervention), 7 and 14
Method of measurement
questionnaire survey (Patient self-report)
Intervention groups
1
Description
Intervention group: Treated with human cord blood serum alginate hydrogel is placed as a layer with a diameter of 5 mm on the 2A degree burn wound and it is bandaged every other day for up to 14 days.
Category
Treatment - Other
2
Description
Control group: Treated with 1% silver sulfadiazine ointment along with a simple hydrogel dressing that is bandaged every other day for up to 14 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
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
Fax
+98 21 8877 0048
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
Mohammad Ali Nilforoushzadeh
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
etaghiabadi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Taghiabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
etaghiabadi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Taghiabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
etaghiabadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Taghiabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
etaghiabadi@sina.tums.ac.ir
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 data can be shared after de-identifying individuals.
When the data will become available and for how long
Six months after the publication and printing of the article
To whom data/document is available
Academic researchers and experts
Under which criteria data/document could be used
In order to analyze the results of the study outcomes
From where data/document is obtainable
etaghiabadi@sina.tums.ac.ir
What processes are involved for a request to access data/document
It can be submitted after review by the Research Council of the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, which usually takes 2 to 3 months.