Increasing the effectiveness of platelet-fibrin glue in the healing of recalcitrant wounds by adding the repairing gel which has the approved components in wound healing
Comparison of the chance of healing chronic wounds with the synergistic treatment of healing gel and fibrin glue
Design
A clinical trial with the control group, factorial, triple-blind, randomized, phase 2-3 on 40 patients. Blocking will be used for randomization.
Settings and conduct
40 patients with chronic wounds, who did not respond to classical treatment after 3 months and the damage is still not healed, are included in the study.
First group: 10 patients will be treated with platelet-fibrin glue in the form of a gel.
Second group:10 patients will be treated with repairing gel.
Third group:10 patients will be treated with repairing gel and platelet-fibrin glue.
Fourth group: for 10 patients with chronic wounds, the classical wound irrigation will be continued.
Place of study: Imam Reza Hospital - Surgery Department - Burns Department
Participants/Inclusion and exclusion criteria
Patients with a wound that has been at least 3 months old and has not been repaired by irrigation with normal saline and changing the dressing.
Intervention groups
First group: 10 patients with chronic wounds, the classical treatment will be performed, and then platelet-fibrin glue in the form of gel will be placed on the patient's wound.
Second group: 10 patients with chronic wounds, the classical treatment for the wound will be performed, and the repairing gel with approved wound healing components in the form of gel will be used.
Third group:1 0 patients with chronic wounds, in addition to the classical treatment, the repairing gel with approved wound healing components and platelet-fibrin glue will be placed on the wound.
Fourth group:10 patients with chronic wounds, only the classical wound irrigation will be continued.
Main outcome variables
wound area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191228045924N5
Registration date:2023-07-10, 1402/04/19
Registration timing:prospective
Last update:2023-07-10, 1402/04/19
Update count:0
Registration date
2023-07-10, 1402/04/19
Registrant information
Name
Daryoush Hamidi Alamdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8574
Email address
hamidiad@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-20, 1402/04/29
Expected recruitment end date
2024-01-19, 1402/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Increasing the effectiveness of platelet-fibrin glue in the healing of recalcitrant wounds by adding the repairing gel which has the approved components in wound healing
Public title
Investigating the effect of repairing gel and platelet-fibrin glue in the healing of wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a single wound on the body that has been at least 3 months old and has not been repaired by wound irrigation with normal saline and changing the dressing
Having a body mass index of 18-35
Sign the informed consent by patient
Exclusion criteria:
Having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney and liver failure, and heart failure
Taking certain drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization, and at certain points the number of participants in each group is equal.
Random number table using www.randomization.com
In the random block method, 10 blocks of four of different permutations of letters ABCD are considered, and patients are divided into four groups accordingly.
Randomization Type: Blocked
Allocation Concealment method
The sealed envelope is used as a means of randomization and concealment. The method of sealed envelopes is that the envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. First, the purpose of the study is explained to the person who meets the stated conditions, and if the person wishes, he signs the informed consent form and takes an envelope, and then opens it based on the contents of the envelope, the person is in group 1 or 2 or 3 or 4 is entered.
Blinding (investigator's opinion)
Triple blinded
Blinding description
First, this study is explained to the participants it is a three-blind study and includes three intervention groups and one control group.
40 patients with chronic wounds, who did not respond to classical treatment after 3 months and the damage is still not healed, are included in the study. 10 patients in each group: Group 1 (fibrin glue) - Group 2 (repairing gel) - Group 3: (platelets-fibrin glue and repairing gel) - Group 4: (classic wound irrigation treatment).
The participants will not know which group they belong to. The statistical analyzer and evaluator are not also informed about the groups.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Mashhad University of Medical Sciences
Street address
Daneshgah street, the central organization of University, Quraishi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-06-17, 1402/03/27
Ethics committee reference number
IR.MUMS.REC.1402.089
Health conditions studied
1
Description of health condition studied
Chronic Wound
ICD-10 code
T01.9
ICD-10 code description
Multiple open wounds, unspecified
Primary outcomes
1
Description
The amount of pain
Timepoint
It is measured after two days of changing the dressing.
Method of measurement
Visual Analogue Scale
2
Description
The duration of recovery, which is the number of days it takes for the wound to heal.
Timepoint
Every 24 hours (every day)
Method of measurement
By visual observation
3
Description
Presence of inflammation and infection
Timepoint
Before the intervention and after the intervention every week for two month
Method of measurement
Clinical examination
4
Description
Quality of Life
Timepoint
Before the intervention and after the intervention
Method of measurement
Completing the SF36 questionnaire
Secondary outcomes
1
Description
Reepithelialisation and wound closure
Timepoint
Every week for two month after dressing
Method of measurement
Clinical observation
Intervention groups
1
Description
First intervention group: 10 patients with chronic wounds, the classical treatment will be performed, and then platelet-fibrin glue in the form of gel will be placed on the patient's wound. The number of times of use: use of repairing gel and fibrin gel is every 48 hours for 8 weeks, and these gels are used on the wound at the time of changing the dressing after irrigation of the wound. Fibrin glue is prepared in the clean room of skin bank of Imam Reza Hospital.
Category
Treatment - Drugs
2
Description
Second intervention group: 10 patients with chronic wounds, the classical treatment for the wound will be performed, and the repairing gel with approved wound healing components in the form of gel will be used. The repairing gel will be manufactured by Omid Rajabi Pharmaceutical Factory, and the dosage of the components used is FDA-approved. The components are vitamin A (0.2 percent) - vitamin C (2 percent) - vitamin B3 (0.5 percent) - glycine amino acid. (0.5 percent) - ethanol (2 percent) - collagen (1 percent) - citric acid (2 percent) - glycerin (0.5 percent) - malic acid (1 percent) - urea (35 percent) - carboxymethyl cellulose (2 percent) - Sodium alginate (1 percent) - Benzoic acid (0.002 percent) - Propylene glycol (0.5 percent) - Methylene blue (0.1 percent) - Violet Dujancin (0.1%) - dimethyl sulfoxide (0.1%), which is prepared as a gel. The number of times of use: use of repairing gel and fibrin gel is every 48 hours for 8 weeks, and these gels are used on the wound at the time of changing the dressing after irrigation of the wound.
Category
Treatment - Drugs
3
Description
Third intervention group:10 patients with chronic wounds, in addition to the classical treatment, the repairing gel with approved wound healing components and platelet-fibrin glue will be placed on the wound. The repairing gel will be manufactured by Omid Rajabi Pharmaceutical Factory, and the dosage of the components used is FDA-approved. The components are vitamin A (0.2 percent) - vitamin C (2 percent) - vitamin B3 (0.5 percent) - glycine amino acid. (0.5 percent) - ethanol (2 percent) - collagen (1 percent) - citric acid (2 percent) - glycerin (0.5 percent) - malic acid (1 percent) - urea (35 percent) - carboxymethyl cellulose (2 percent) - Sodium alginate (1 percent) - Benzoic acid (0.002 percent) - Propylene glycol (0.5 percent) - Methylene blue (0.1 percent) - Violet Dujancin (0.1%) - dimethyl sulfoxide (0.1%), which is prepared as a gel. Fibrin glue is prepared in the clean room of skin bank of Imam Reza Hospital. The number of times of use: use of repairing gel and fibrin gel is every 48 hours for 8 weeks, and these gels are used on the wound at the time of changing the dressing after irrigation of the wound.
Category
Treatment - Drugs
4
Description
Control group: 10 patients with chronic wounds, only the classical wound irrigation will be continued. The number of times of use: Every 48 hours for 8 weeks, the dressing is changed on the wound.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Daryoush Hamidi Alamdari
Street address
Imam Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 915 101 7650
Email
hamidiad@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Daneshgah Street, Central Organization of University, Qurashi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Daneshgah Street, Surgical Oncology Research Center, Mashhad University of Medical Sciences, General Surgery Department, Building No. 2, Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9133913716
Phone
+98 915 101 7650
Email
hamidiad@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Email
hamidiad@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Email
hamidiad@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
All data related to the project after the unidentifiable people will be shared.
When the data will become available and for how long
After the completion of the study and data analysis, approximately 5 months after the completion of the interventions
To whom data/document is available
Researchers working in academic and scientific institutions and physicians
Under which criteria data/document could be used
According to the policies of the journal in which the article will be published, the data will be made available.
From where data/document is obtainable
the corresponding author of the article
What processes are involved for a request to access data/document
n The request should be sent by email to the corresponding author and he will respond as soon as possible after reviewing the request.