Evaluation of wound healing effects using chitosan-based gel preparation in patients with grade 2 and 3 wounds and if positive results be obtained, this method can be used to reduce complications in patients with grade 2 and 3 wounds.
Design
In this study, all participants will enter the study after reviewing the inclusion criteria and obtaining informed consent. This study consists of 2 groups. The group treated with chitosan base gel (group 1) is performed in patients suffering from 2 and 3 grade wounds and dressing with sterile bilayer gas. In contrast, the control group (group 2) was treated with conventional
Settings and conduct
Molecular Medicine Research Center, Arak University of Medical Sciences, Sepahan and wound healing special clinic, Esfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering 2 and 3 grade wounds; Age range 18 to 60 years;
Exclusion criteria: The patient has already or three months before the referral participated in another clinical trial study ; The patient is allergic to seafood.
Intervention groups
The group treated with chitosan base gel (group 1) is performed in patients suffering from 2 and 3 grade wounds and dressing with sterile bi-layer gas. In contrast, the control group (group 2) was treated with conventional methods.
Main outcome variables
Wound size, wound dept, wound healing time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210510051243N2
Registration date:2022-04-03, 1401/01/14
Registration timing:prospective
Last update:2022-04-03, 1401/01/14
Update count:0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Hamid Abtahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
abtahi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chitosan based prepared gel on healing Grade 2 and 3 wounds: A clinical trial study
Public title
The effect of chitosan based prepared gel on healing Grade 2 and 3 wounds
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering grade 2 and 3 wounds
Exclusion criteria:
The patient has already or three months prior to referral has participated in another clinical trial study.
Presence of sensitivity to seafood
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:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. To do this, the online Sealed envelope site will be used. Blocks of size 4 will be used. So that all possible sequences of two intervention and two control treatment in each block will be made with each block being numbered. Then, using random number table, the blocks will be selected randomly and the patients will be assigned to the two groups of intervention and control according to the blocks sequences
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
Arak University of Medical Sciences, Arak, Iran
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.ARAKMU.REC.1400.355
Health conditions studied
1
Description of health condition studied
grade 2 and 3 wounds
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
wound size
Timepoint
every week
Method of measurement
ruler
2
Description
wound healing time
Timepoint
every week
Method of measurement
counting days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: groups treated with chitosan gel (group 1) in patient suffering from grade 2 and 3 wounds
Category
Treatment - Drugs
2
Description
Control group: patients suffering from grade 2 and 3 wounds receiving common tratments
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sepahan Wound Health Specialized Clinic
Full name of responsible person
Hasan Jafari
Street address
Isfahan, Shohada Soffeh Blvd. Khanevadeh-Hospital- Sepahan Wound Health Specialized Clinic
City
Esfahan
Province
Isfehan
Postal code
8174786398
Phone
+98 31 3620 1375
Email
info@salamatzakhm.com
Web page address
https://salamatzakhm.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Abtahi
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3383 8268
Email
abtahi@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamid Abtahi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3502
Email
abtahi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Abtahi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Medical and Molecular Research Center, School of Medicine, Pardis site of University of Medical Sciences, Basij Square, Arak city
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3502
Email
abtahi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Abtahi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Medical and Molecular Research Center, School of Medicine, Pardis site of University of Medical Sciences, Basij Square, Arak city
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3502
Email
abtahi@arakmu.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
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
The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.
When the data will become available and for how long
The non-identifiable individual participant data will become available after the publication of the relevant articles.
To whom data/document is available
The non-identifiable individual participant data will become available to other researchers in academic institutions.
Under which criteria data/document could be used
The non-identifiable individual participant data can only be used for research.
From where data/document is obtainable
The non-identifiable individual participant data will be obtainable by sending an e-mail to Dr. Hamid Abtahi (Email: abtahi@arakmu.ac.ir).
What processes are involved for a request to access data/document
Other researchers in academic institutions can send their request by e-mail to Dr. Hamid Abtahi (Email: abtahi@arakmu.ac.ir). The data will be sent to them after consulting and approving the research team.