Efficacy evaluation of a hydrogellic collagen/PVA wound dressing containing hybrid curcumin/chitosan nanoparticles combined with endometrial mesenchymal stem cell condition medium in burn wound (clinical phase 1 & 2)
Design
Clinical trial with one control group parallel with one intervention group, double-blind, randomized based on random number table, phase 1-2 on 20 burn patients
Settings and conduct
The research site is Motahari Burn Hospital and Skin and Stem Cell Research Center. Blinding will be performed in a way that the patient the caregiver are both unaware of type and structure of dressings.
Participants/Inclusion and exclusion criteria
Patients 18-50 years old with grade 2 burns
Intervention groups
_The intervention group includes 10 patients receiving wound dressing together with condition medium
_control group receiving standard tretment
Main outcome variables
The amount of granulation tissue, the duration of wound healing, the area of wound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220512054831N1
Registration date:2022-07-09, 1401/04/18
Registration timing:registered_while_recruiting
Last update:2022-07-09, 1401/04/18
Update count:0
Registration date
2022-07-09, 1401/04/18
Registrant information
Name
Reza Naser
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2245 4327
Email address
rnit101@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy evaluation of a collagen/PVA wound dressing containing hybrid curcumin/chitosan nanoparticles combined with mesenchymal stem cell condition medium in burn wound (clinical phase 1 & 2)
Public title
combined efficacy of wound dressing and mesenchymal condition medium on burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
second degree burn
Exclusion criteria:
Immune disorders, malignancy and underlying conditions such as type 1 diabetes
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method using a random number table will be applied. Each patient receives a code between 01 and 20 respectively right after registration.The researcher receives the numbers and randomly starts from one point on the table and proceeds until the the first number with digits between 01 to 20 on the right is seen. This code corresponds to one of the patients and this process repeats until our control group is completed. After that, the 10 remaining patients are categorized as intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to make the process blind for clinical operator; packages of wound dressings will be designed with identical shapes and with similar contents which will be indistinguishable.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2022-04-26, 1401/02/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.100
Health conditions studied
1
Description of health condition studied
Burn and wound
ICD-10 code
T21.20X
ICD-10 code description
Burn of second degree of trunk, unspecified site, initial encounter
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
Wound imaging and analysis using Image J 1.52v software (scientific image processing and analysis software)
Secondary outcomes
1
Description
Pain from burn wound
Timepoint
Right before intervention and six days after the first intervention
Method of measurement
questions and answers from the patient
Intervention groups
1
Description
In the intervention group, collagen dressing containing condition medium soaked PVA nanofibers, loaded with curcumin/chitosan nanospheres will be applied on wounds. Based on animal studies, durability of the dressing is about 6 days but it is renewable until wound closure if it is clinically necessary. The duration of intervention will be 3 weeks. The weight ratio of nanosphere to total wound dressing is 1%.
Category
Treatment - Devices
2
Description
In control group, an available standard wound dressing based on clinician's prescription in Motahari burns hospital will be applied by following the protocols identically for all patients of group. The description of treatment and protocol will be available in details in the report of the clinical trial.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
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, Tehran, Iran
No 88, Italia Street, Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
rnit101@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not 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
Only information about the main outcome or the suchlike can be shared.
When the data will become available and for how long
Access period 3 months after publication of the report
To whom data/document is available
The data can be made available to research and academic institutions.
Under which criteria data/document could be used
The data can be used for research, industrial and production purposes of medical equipment by observing the intellectual rights of researchers.ق
From where data/document is obtainable
Rnit101@gmail.com
Reza Naser
What processes are involved for a request to access data/document
For research purposes, information will be available after a period of one week.
For industrial and production purposes, information will be available after receiving and approving the process proposal by researchers.