Increasing the chance of healing second-degree burn wounds by increasing the effectiveness of PRP-FG in combination with the approved components in wound healing
Design
A clinical trial with the control group, factorial, Non-blind, Non-randomized, phase 2-3 on 40 patients.
Settings and conduct
First, the presence of second-degree burns and the conditions of using the treatment for the patient are confirmed by the specialist doctor at Imam Reza Hospital. After obtaining consent, the patient will be non-randomly and without blinding assigned to one of the 4 study groups (PRP-FG, Supraz, PRP-FG+Supraz, and Control). Interventions will be performed in the burn department of Imam Reza Hospital (Mashhad, Iran).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having second-degree burns
No smoking, alcohol, or drug addiction
Not taking drugs that may interfere with wound healing
Not having concurrent diseases that may cause problems in wound healing
Informed consent of patients
Exclusion criteria:
The presence of a wound with an active infection or gangrene
Failure to refer the patient for follow-up
Intervention groups
Group 1: PRP-FG is placed in the form of gel on the wound of 10 patients for 8 weeks.
Group 2: approved compounds are placed in the form of gel on the wounds of 10 patients for 8 weeks.
Group 3: The repairing gel used in the second group is placed on the wounds of 10 patients, and then platelet-rich fibrin is placed on it for 8 weeks.
Group 4: For 10 patients with chronic wounds, only classical wound irrigation by normal saline (0.9%) will be continued for 8 weeks.
Main outcome variables
The size of the wound; Pain; and Time of the wound changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191228045924N6
Registration date:2023-11-12, 1402/08/21
Registration timing:prospective
Last update:2023-11-12, 1402/08/21
Update count:0
Registration date
2023-11-12, 1402/08/21
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
2023-12-22, 1402/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of second-degree burn wound with PRP-Fibrin glue and repairing gel
Public title
Effect of PRP-Fibrin glue and Repairing gel in treatment of second-degree burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of second-degree burns
Having a body mass index of 18-35
No smoking, alcohol and drug addiction
Not taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents
Not having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney, liver, and heart failures
Informed consent of patients
Exclusion criteria:
The presence of a wound with an active infection requiring intravenous antibiotics or gangrene requiring amputation
Failure to refer the patient to the mentioned center for follow-up and dressing change on more than two occasions
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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 construction
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-09-09, 1402/06/18
Ethics committee reference number
IR.MUMS.REC.1402.163
Health conditions studied
1
Description of health condition studied
Burn of second degree
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Change from Baseline Wound Size (length and width) will be assessed in digital images taken of the wound.
Timepoint
At the beginning of the study (0 days) and at the end of the eighth week of the intervention (8 weeks).
Method of measurement
digital images and ruler
2
Description
Visual Analog Scale changes for pain assessment
Timepoint
Every 48 hours for 8 weeks
Method of measurement
Pain will be evaluated by the visual analog scale system (VAS). The score is determined by measuring the distance (mm) between the no-pain anchor and the point that the patient marks, providing a range of scores from 0 - 10. A higher score indicates greater pain intensity.
3
Description
The duration of recovery is the number of days it will take for the wound to heal.
Timepoint
The interval from the beginning of the study (0 days) to wound healing
Method of measurement
Counting days
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: For 10 patients with second-degree burns, platelet-fibrin glue in the form of gel will be placed on the patient's wound. The number of times of use: use of fibrin gel is every 48 hours for 8 weeks, and this gel is 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 the skin bank of Imam Reza Hospital. Fibrin glue is prepared in the clean room of the skin bank of Imam Reza Hospital from platelet and cryo samples taken from blood transfusion organization by project researchers and is not commercial.
Category
Treatment - Drugs
2
Description
Second intervention group: 10 patients with second-degree burns, 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%). The number of times of use: use of repairing 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 second-degree burns, 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%). 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 second-degree burns, 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
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Seyed Hasan Tavousi
Street address
Imam Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 915 511 8717
Email
TavoosiH@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
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
Seyed Hasan Tavousi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
BURN
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
+98 915 511 8717
Email
TavoosiH@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
Undecided - It is not yet known if there will be a plan to make this available