Fabrication and evaluation of the effectiveness of the new generation of wound dressings based on Gelatin/Chitosan hydrogel containing nanoparticles and mesenchymal stem cells derived condition medium to accelerate the healing of wounds (phase 1 & II clinical trial)
Fabrication and evaluation of the effectiveness of the new generation of wound dressings based on Gelatin/Chitosan hydrogel containing nanoparticles and mesenchymal stem cells derived condition medium to accelerate the healing of wounds (phase 1 & II clinical trial)
Design
Clinical trial with two control groups and one intervention group, with parallel groups, double-blind, randomized based on random number table, phase 1-2 on 30 burn patients
Settings and conduct
The intervention site is Motahari Burn Hospital and Skin and Stem Cell Research Center. In this study, a course was performed and not all patients, including the patient and the data analyzer, were aware of the type and structure of the dressing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 18-50 years old with grade 2 burns. Exclusion criteria: Patients with chronic inflammatory diseases and immune disorders
Intervention groups
The study groups will include 10 people receiving medium conditioned wounds, 10 people receiving medium conditioned wounds and 10 people receiving 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:IRCT20200127046282N17
Registration date:2022-06-02, 1401/03/12
Registration timing:prospective
Last update:2022-06-02, 1401/03/12
Update count:0
Registration date
2022-06-02, 1401/03/12
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
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
Fabrication and evaluation of the effectiveness of the new generation of wound dressings based on Gelatin/Chitosan hydrogel containing nanoparticles and mesenchymal stem cells derived condition medium to accelerate the healing of wounds (phase 1 & II clinical trial)
Public title
Evaluation of the effectiveness of wound dressing based on gelatin/chitosan hydrogel to accelerate wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-50 years
Patients with grade 2 burns
Exclusion criteria:
Patients with chronic inflammatory diseases
Patients with impaired immune system
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are divided into three groups based on a simple randomization method using a random number table. In this method, a set of non-patterned numbers is randomly generated and converted into a table. Each of the 30 patients in the study has a random number. The number of each person in measure 3 is equal to zero, one or two. Module zero will be the intervention group, module one and two of each control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
30 patients are divided into three groups of 10 to study. The study groups will include 10 people receiving medium conditioned wounds, 10 people receiving medium conditioned wounds and 10 people receiving standard treatment.
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
2022-05-11, 1401/02/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.146
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
Control group: Ten people will receive standard treatment.
Category
Treatment - Other
2
Description
Control group: Ten people will receive non-conditioned wound dressings.
Category
Treatment - Other
3
Description
Intervention group: Ten people will receive medium-conditioned wounds.
Category
Treatment - Other
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