Comparison of the effect of topical application of platelet-enriched fibrin glue with conventional dressing method on the second-degree burns wound healing
1) Comparison of the effect of local use of platelet-enriched throat fibrin with the usual dressing method on second degree burn wound healing according to age and gender
2) Comparison of the effect of the local use of platelet-enriched throat fibrin with the usual dressing method on the healing of 2nd degree burn wounds according to the type of burn.
3) Comparison of the effect of the local use of platelet-enriched throat fibrin with the usual dressing method on the healing of 2nd degree burn wounds in terms of burn percentage.
4) Comparison of the effect of local use of platelet-enriched throat fibrin with the usual dressing method on the healing of 2nd degree burn wounds according to the burn site.
5) Comparison of the effect of local use of platelet-enriched throat fibrin with the usual dressing method on second degree burn wound healing in terms of burn complications.
Design
A clinical trial with a control group and a parallel, one-sided blind, randomized with a table of random numbers will be conducted on 23 patients.
Settings and conduct
In the burn department of Imam Reza Hospital, Mashhad. Patients are unaware of the type of dressing, but the researcher is aware
Participants/Inclusion and exclusion criteria
Entry criteria:
- 2nd degree burn confirmed by a doctor
- Burn percentage between 5 and 20%
- Willingness to participate in the study
- Age between 18 and 60 years
Non-entry criteria:
- Existence of a known systemic disease affecting wound healing, such as type 2 diabetes
- Lack of consent to continue participating in the study
- Skin sensitivities when using the dressing
- Patients with underlying skin problems
Intervention groups
In the intervention group, platelet-enriched throat fibrin dressing was used, and in the control group, the common dressing used in the burn department was used.
Main outcome variables
Speed up recovery time
Scar reduction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220628055309N1
Registration date:2022-08-20, 1401/05/29
Registration timing:registered_while_recruiting
Last update:2022-08-20, 1401/05/29
Update count:0
Registration date
2022-08-20, 1401/05/29
Registrant information
Name
Mohammad amin Khojaste nezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3620 2366
Email address
amin.khojaste89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical application of platelet-enriched fibrin glue with conventional dressing method on the second-degree burns wound healing
Public title
Investigating the effect of platelet-enriched fibrin glue on second-degree burn wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2nd degree burn certified by a doctor
Burn percentage between 5 and 20
Trend to participate in the study
Age between 18 and 60 years
Exclusion criteria:
Existence of systemic disease known to be effective on wound healing, such as type 2 diabetes
ِِِِDissatisfaction to continue participating in the study
Skin sensitivities while using the dressing
Patients with chronic skin problems
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
Each person must have two wounds of the second degree burn on the body at the same time, one of which will be dressed with a normal dressing and the other with a dressing impregnated with fibrin glue enriched with platelets.
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be conducted in two intervention and control groups in a one-sided blind way on patients with 2nd degree burns. So that each person must simultaneously have two separate 2nd degree burns on the body, which type of dressing to be done for that wound will be selected by a table of random numbers after the first wound is selected for dressing by the doctor. Obviously, the second wound on that person's body will be dressed with another type of dressing.
Blinding (investigator's opinion)
Single blinded
Blinding description
The dressings are pre-prepared and have the same appearance that the participant is unaware of the ingredients in them, but the researcher is.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Mashhad of Medical Sciences
Street address
No.11, Shahed 79/3,Shahed ave, Ghasem abad
City
Mashhad
Province
Razavi Khorasan
Postal code
9189985478
Approval date
2022-02-23, 1400/12/04
Ethics committee reference number
IR.IAU.MSHD.REC.1401.008
Health conditions studied
1
Description of health condition studied
Superficial 2nd degree burn
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Wound healing rate: Patients will be examined by the attending physician in both groups for two weeks or until discharge or death at two-day intervals. So that the speed of wound healing in two groups will be compared on the fifth, seventh, ninth, eleventh and thirteenth days. The effectiveness of the dressings will be considered with the improvement of more than 90% of the wound, which will be determined by the opinion of the specialist doctor and the patient's therapist.
Timepoint
The speed of wound healing in two groups will be compared on the fifth, seventh, ninth, eleventh and thirteenth days.
Method of measurement
More than 90% healing of the wound, which is according to the opinion of a specialist doctor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In people with superficial 2nd degree burns who have burns in two areas of the skin, in one of the areas of the burn, a dressing containing throat fibrin enriched with platelets is used. Then the patients will be examined in terms of the degree of healing by the attending physician for two weeks or until discharge or death at intervals of two days.
Category
Treatment - Surgery
2
Description
Control group: In patients with 2nd degree superficial burns who have burns in two areas of the skin, a normal dressing will be used in one of the burned areas. Normal dressing includes Vaseline gas with or without burn ointments according to the doctor's diagnosis and in the same way as it has been commonly used in the department. Then the patients will be examined by the attending physician for two weeks or until discharge or death at intervals of two days.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mohamad Amin Khojaste Nezhad
Street address
No11, Shahed ave, Shahed 79/3, Ghasem Abad
City
Mashhad
Province
Razavi Khorasan
Postal code
9189985478
Phone
+98 51 3620 2366
Email
amin.khojaste89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Ahmad Abadi
Street address
Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3843 3999
Email
amin.khojaste89@gmail.com
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
Mohamad Amin Khojaste Nezhad
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3843 3999
Email
amin.khojaste89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Amin Khojaste Nezhad
Position
Medical Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No.31, Hashemie 24 Ave, Hashemie Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9189985478
Phone
+98 51 3620 2366
Fax
Email
amin.khojaste89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Amin Khojaste Nezhad
Position
Medical student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No.11, Shahed 79/3 Ave, Shahed Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9189985478
Phone
+98 51 3620 2366
Fax
Email
amin.khojaste89@gmail.com
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available