Determining the adjunctive effect of light therapy in some criteria on wound healing in burns patient
Design
A single-blind study will be conducted on 50 patients. The samples are placed in two intervention and control groups by random block allocation method.
Settings and conduct
The samples are burn patients hospitalized in Imam Musa Kazem (AS) Isfahan, who are placed in two intervention and control groups by random block allocation method. Blinding is done in such a way that the data collectors and wound evaluators will not be aware of the allocation method and the device users will not participate in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 18-60 years; burn percentage 20% to 40%; burn degree 2 superficial and deep; Burns with hot liquids or hot steam
Exclusion criteria:
lack of consent and cooperation of patients to participate in the study; history of underlying disease; more than 6 hours from the occurrence of the burn to admission to the hospital; BMI less than 18.5 and more than 30
Intervention groups
Light irradiation will be daily for 6 minutes in 10 sessions, with a distance of 10 cm from the wound (13). If the patient is discharged before the end of light therapy sessions or wound closure, follow-up will be done for the participant's daily visit until the wound is closed and the light therapy sessions are completed.
Before each dressing session, the wound will be opened and washed with 0.9% saline wash. Then, the usual treatment protocol for the wound will be implemented. In the control group, the wound will be exposed to open air for 6 minutes.
Main outcome variables
Outcome variables include: The Vancouver Scar scale, serum level of neutrophils, serum level of lymphocytes, and wound evaluation score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230108057074N1
Registration date:2023-03-06, 1401/12/15
Registration timing:registered_while_recruiting
Last update:2023-03-06, 1401/12/15
Update count:0
Registration date
2023-03-06, 1401/12/15
Registrant information
Name
Ehsaneh Najari ardestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3462 3648
Email address
ehsanehnajari@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adjunctive effect of light therapy in some criteria on wound healing in burns patient
Public title
Adjunctive effect of light therapy in some criteria on wound healing in burns patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with 18-60 years
total burn surface area 20%-40%
burn degree:2 partial thickness and full thickness
burn injury with scald
Exclusion criteria:
History of underlying disease, immune system disorders/blood circulation disorders/substance abuse and pregnancy
A history of taking blood thinners
The interval of more than 6 hours from the occurrence of burns to admission to the hospital
Presence of trauma in the wound
BMI less than 18.5 and more than 30
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into intervention and control groups by random block allocation method. The total volume of the sample is divided into smaller groups that can be divided and an integer number is obtained, called blocks, so that inside each block there are four people from The sample volume is placed. Due to the fact that with a sample size of 30 and a block of 4, an integer number is not obtained, so the number 32 is considered. The placement of people (4 people) inside each block is imagined and recorded from the total sample size of the test and control group {(CACA)(CCAA)(ACCA)(ACAC)}. A number is assigned to each of these situations and recorded (CACA=4)(CCAA=3)(ACCA=2)(ACAC=1). The numbers are written on spherical objects of the same size and color and are thrown into the bag, and a person who is not in the work flow is asked to remove the objects from the bag for the required number of blocks, however repeated, and after Registering the number on the item, the item is returned to the bag. In this way, sampling is done according to the order of the blocks and the number taken out of the bag. It is necessary to explain that the previous block must be completed in order to complete the next block.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data gatherer and wound evaluator do not know اow to allocate groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-09-12, 1401/06/21
Ethics committee reference number
IR.ARI.MUI.REC.1401.188
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T20-T32
ICD-10 code description
Burns and corrosions
Primary outcomes
1
Description
Wound healing score
Timepoint
At the admission until the wound is closed, daily
Method of measurement
A photo will be taken of the patient's wound with a standard camera at a distance of 40 cm on a white background with sufficient light, and the evaluation form will be filled out daily for participation. will be completed.Wound healing parameters will be performed according to the standard method described by Monstrey et al., which includes edema of the burned area; type of wound discharge; the amount of wound discharge; type of necrotic tissue in the wound; amount of necrotic tissue in the wound; The degree of granulation of the wound and the degree of epithelization of the wound. Each parameter will be given a score from 1 to 5 according to the Likert scale. The wound evaluation form will be completed based on the photos taken by two plastic surgery specialists with more than 15 years of experience in the field of burns. A complete patient history without treatment details will be provided to the evaluators. Based on the photos taken of the wound, they will independently answer the questions in the wound evaluation section.
2
Description
Serum level of white blood cells
Timepoint
The review of paraclinical results will be based on the hospital protocol at the arrival of the patient and once every three days, and no other blood samples will be taken from the patient.
Method of measurement
Based on the sample taken from the patient
3
Description
The Vancouver Scar scale
Timepoint
In order to follow up after the first month, second month and sixth month after the end of the intervention, photographs will be taken of the light therapy site. To evaluate the scar, The Vancouver Scar scale will be used in 1, 3, and 6 months after the end of the intervention.
Method of measurement
Using The Vancouver Scar scale at 1, 3, 6 months after the end of the intervention
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bioptron light therapy device (Bioptron AG, Wollerau, Switzerland) from Mehrgan Tejarat Carmania Company, made in Switzerland, in accordance with EEC/93/42 light with wavelength characteristics of 480 to 3400 nm, polarization percentage 95%, power density 40 mW/cm2 and emits 4.2 J/cm2 energy per minute. Light irradiation will be daily for 6 minutes in 10 sessions, with a distance of 10 cm from the wound (13). If the patient is discharged before the completion of the light therapy sessions or the wound closure, follow-up will be done for the participant's daily visit until the wound is closed and the light therapy sessions are completed. Before each session, the wound will be opened and washed with saline. 0% will be washed. After the participant is in a comfortable position, the device will be placed towards the wound to shine the light. Then, according to the doctor's order, the usual treatment protocol for the wound will be implemented.
Category
Treatment - Devices
2
Description
Control group: Control group: the wound will be exposed to the open air for 6 minutes, then according to the doctor's order, the usual treatment protocol for the wound will be implemented.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Musa Kazem (a.s.) hospital
Full name of responsible person
Ehsaneh Najari Ardestani
Street address
Kaveh Avenue, Imam Musa Kazem (a.s.) hospital
City
Esfahan
Province
Isfehan
Postal code
8138894999
Phone
+98 31 3345 7670
Fax
+98 31 3345 8803
Email
ehsanehnajari@mail.mui.ac.ir
Web page address
https://savaneh.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsaneh Najari Ardestani
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ehsanehnajari@mail.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ehsaneh Najari Ardestani
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ale Mohammad Avenue
City
Esfahan
Province
Isfehan
Postal code
8193661971
Phone
+98 31 3345 7670
Email
ehsanehnajari@mail.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsaneh Najari Ardestani
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 22. Ale mohammad Ave. Esfahan
City
Esfahan
Province
Isfehan
Postal code
8193661971
Phone
+98 31 3462 3648
Fax
Email
ehsanehnajari@mail.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsaneh Najari Ardestani
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 22. Ale mohammad Ave. Esfahan
City
Esfahan
Province
Isfehan
Postal code
8193661971
Phone
+98 31 3462 3648
Fax
Email
ehsanehnajari@mail.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
We intend to publish it as an article
When the data will become available and for how long
We intend to publish it as an article
To whom data/document is available
We intend to publish it as an article
Under which criteria data/document could be used
We intend to publish it as an article
From where data/document is obtainable
We intend to publish it as an article
What processes are involved for a request to access data/document