Clinical trial NCT03699852: Effect of Photobiomodulation in a Partial Thickness Autogenous Skin Graft Donor Area
Official title: Characterization of the Repair Process and the Effects of Photobiomodulation in a Donor Area of Partial Thickness Skin Graft After Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healing Wound
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical study with a controlled series of cases, whose objectives were: to evaluate the effects of FBM, using LED, on the repair process of the skin graft donor area treated with Membracel® and LED versus Membracel ®; to evaluate the evolution of the quality of the aspects of the skin donor area, through the score obtained by the modified Bates-Jensen Scale; the intensity of the pain reported by the participants; the size of the wound area until the 7th postoperative (PO) period and the time for re-epithelialization of the donor area. Data collection was performed at the Burn Unit of the General Hospital "Dr. José Pangella", from Vila Penteado, São Paulo, Brazil. The sample consisted of 21 participants and 25 donor areas, 13 of which were from the control group, which received only conventional treatment (Membracel®) and 12 from the experimental group: Membracel® and LED. Data collection instruments were used: medical records of the participants, anamnesis and physical examination, the scales: pain (Visual Analogic Scale - VAS) and Bates-Jensen to accompany the re-epithelialization process and the measurement of donor skin areas in the postoperative period. Quantitative variables were represented by the mean, standard deviation and the median and interquartile range. The comparison of the distributions of these variables between groups was performed using the Mann-Whitney test.

Detailed description: The use of FBM, showing beneficial effects on wounds, is well described in the literature. The reported findings include anti-inflammatory action, better tissue organization, acceleration of angiogenesis, stimulation of leukocyte chemotaxis and reduction of donor area size in animals and humans. This is a clinical study with a controlled series of cases, whose objectives were: to evaluate the effects of FBM, using LED, on the repair process of the skin graft donor area treated with Membracel® and LED versus Membracel ®; to evaluate the evolution of the quality of the aspects of the skin donor area, through the score obtained by the modified Bates-Jensen Scale; the intensity of the pain reported by the participants; the size of the wound area until the 7th postoperative (PO) period and the time for re-epithelialization of the donor area. Data collection was performed at the Burn Unit of the General Hospital "Dr. José Pangella", from Vila Penteado, São Paulo, Brazil, from December 2018 to January 2020. The sample consisted of 21 participants and 25 donor areas, 13 of which were from the control group, which received only conventional treatment (Membracel®) and 12 from the experimental group: Membracel® and LED. Data collection instruments were used: medical records of the participants, anamnesis and physical examination, the scales: pain (Visual Analogic Scale - VAS) and Bates-Jensen to accompany the re-epithelialization process and the measurement of donor skin areas in the postoperative period. Participants were identified by Arabic numbers, according to the order of arrival at the Hospital. Quantitative variables were represented by the mean, standard deviation and the median and interquartile range. The comparison of the distributions of these variables between groups was performed using the Mann-Whitney test.

Eligibility criteria: Inclusion Criteria:

* Patients with burns requiring a partial thickness skin graft from a healthy donor area;
* Both sexes;
* Aged 18 years or older;
* Regardless of skin color or comorbidities.

Exclusion Criteria:

* Patients with a full-thickness skin donor area;
* Under the age of 18;
* Those who refuse to participate;
* With infected wounds that evolved with purulent exudation during treatment;
* Cancer participants treated with radiation therapy or chemotherapy;
* With systemic infection;
* Corticosteroid use.

Primary outcomes:
measure: Change in the Bates-Jensen Wound Assessment Tool (BWAT)
timeFrame: Every two days until wound reepithelialization
measure: Change in the Analogic visual scale
timeFrame: Every two days, until the 7th day after the procedure.
measure: Time for donor area reepithelialization
timeFrame: Once a week
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Rosadelia M Carboni, Student
role: PRINCIPAL_INVESTIGATOR
References: