]>
IRCT20230108057074N1 IRCT 2023-03-06 Esfahan University of Medical Sciences Adjunctive effect of light therapy in some criteria on wound healing in burns patient Adjunctive effect of light therapy in some criteria on wound healing in burns patient 2023-01-21 anticipated 50 Complete https://irct.ir/trial/67929 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: The data gatherer and wound evaluator do not know اow to allocate groups. N/A burn. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: We intend to publish it as an article When: We intend to publish it as an article To whom: We intend to publish it as an article Conditions: We intend to publish it as an article Where to obtain: We intend to publish it as an article How to obtain: We intend to publish it as an article Comments: We intend to publish it as an article
public Ehsaneh Najari Ardestani
Ale Mohammad Avenue
Esfahan Iran (Islamic Republic of) 8193661971 +98 31 3345 7670 ehsanehnajari@mail.mui.ac.ir Esfahan University of Medical Sciences scientific Ehsaneh Najari Ardestani
No. 22. Ale mohammad Ave. Esfahan
Esfahan Iran (Islamic Republic of) 8193661971 +98 31 3462 3648 ehsanehnajari@mail.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) patient with 18-60 years total burn surface area 20%-40% burn degree:2 partial thickness and full thickness burn injury with scald 18 years 60 years Both 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 T20-T32 Burns and corrosions Treatment - Devices Treatment - Devices 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. 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. 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. 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. 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. Esfahan University of Medical Sciences Approved 2022-09-12 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences,Isfahan,Iran Esfahan Isfehan Iran (Islamic Republic of)