Investigation of the safety and efficacy of gelatin-chitosan hydrogel-based wound dressing in second degree B burn repair: a clinical trial
Design
Clinical trial with a control group and an intervention group, with parallel groups, single-blind, randomized according to a random number table, phase 1 on 10 burn patients
Settings and conduct
The intervention site is Motahari Burn Hospital and Skin and Stem Cell Research Center. Blinding was performed in this study and the data analyst was unaware of the type and structure of the dressing in question.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with second-degree B burns, age 18 to 45 years, limited areas of involvement. Exclusion criteria: Patients with chronic inflammatory underlying diseases, patients with immune system disorders
Intervention groups
In the intervention group, patients will receive wound dressings every other day, and in the control group, patients will receive standard treatment.
Main outcome variables
The amount of granulation tissue, the duration of wound healing, the size of the wound surface
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N56
Registration date:2025-11-12, 1404/08/21
Registration timing:prospective
Last update:2025-11-12, 1404/08/21
Update count:0
Registration date
2025-11-12, 1404/08/21
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-21, 1404/08/30
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the safety and efficacy of gelatin-chitosan hydrogel-based wound dressing in second degree B burn repair: a clinical trial
Public title
Studying the effect of gelatin-chitosan hydrogel-based wound dressing on burn healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with second-degree burns B
Age 18 to 45 years
Limited affected areas
Exclusion criteria:
Patients with chronic inflammatory diseases
Patients with impaired immune system
Age
From 18 years old to 45 years old
Gender
Both
Phase
1
Groups that have been masked
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are divided into two groups based on a simple randomization method using a random number table. In this method, a set of numbers without a pattern is randomly generated and tabulated. Each of the 10 study patients has a random number.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst does not know how the study was grouped.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Working Group/Committee, Faculty of Medicine - Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2025-07-14, 1404/04/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.249
Health conditions studied
1
Description of health condition studied
Burn and wound
ICD-10 code
T23.2
ICD-10 code description
Burn of second degree of wrist and hand
Primary outcomes
1
Description
The size of the granulation tissue formed in the wound
Timepoint
Before the intervention and six days after the last intervention
Method of measurement
Wound imaging and analysis using Image J 1.52v software (scientific image processing and analysis software)
2
Description
Wound surface and depth
Timepoint
Before the intervention and six days after the last intervention
Method of measurement
Software Image J
Secondary outcomes
1
Description
Pain from burn wounds
Timepoint
Six days after the first intervention
Method of measurement
In the form of questions and answers from the patient
Intervention groups
1
Description
Intervention group: In the intervention group, patients will receive wound dressings every other day.
Category
Treatment - Other
2
Description
Control group: patients will receive standard treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Vice President for Research and Technology, 6th Floor, Central University Organization, corner of Qods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@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
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
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sharif University of Technology
Full name of responsible person
Amir Shamloo
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Mechanical Engineering, Sharif University of Technology, Azadi Street
City
Tehran
Province
Tehran
Postal code
14588889694
Phone
+98 21 66161
Email
shamloo@sharif.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@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
Not applicable
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