Characterization of the Repair Process and the Effects of Photobiomodulation in a Donor Area of Partial Thickness Skin Graft After Burn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in the Analogic visual scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
LED group
The study had two groups of participants: the LED group (GL) and the control group (GC), both with Membracel®, a porous membrane that regenerates crystalline cellulose, as the primary cover in the donor area of the skin graft (no secondary cover was used) ). In one of the groups (GL), a light-emitting diode (LED) plate was applied, which was covered with sterile waterproof and transparent film to prevent contamination. The participant was positioned so that the skin graft donor area was accessible. The LED plate covered the entire skin donor area and was irradiated with a radiant exposure of 1.53J / cm2 and irradiance of 2.55 mW / cm2 for 10 minutes. The LED plate was applied in contact with the skin graft donor area in the immediate postoperative period and on Membracel® on the 1st, 3rd, 5th and 7th postoperative days. The primary coverage remained until spontaneous removal.
干预措施: Membracel and LED photobiomodulation (Radiation)
Control group
The participants remained and were evaluated under the same conditions. The only difference between the groups is that no LED photobiomodulation session was applied to the control group.
干预措施: Membracel (Other)
结局指标
主要结局
Change in the Analogic visual scale
时间窗: Every two days, until the 7th day after the procedure.
The scale allows for "validation" by the participant, as he or she experiences pain and is therefore an expert on the pain pattern, location, intensity and nature.
Time for donor area reepithelialization
时间窗: Once a week
The LED Group and Control Group donor areas were evaluated for time to reepithelialization. They were considered completely reepithelized when no exudate was noted, the participant reported no pain with exposure of the wound to ambient air and was completely devoid of Membracel coverage and hematic crusts.
Change in the Bates-Jensen Wound Assessment Tool (BWAT)
时间窗: Every two days until wound reepithelialization
This scale evaluates size, depth, edges, detachment, type and amount of necrotic tissue, type and amount of exudate, edema and hardening of the peripheral tissue, skin color around the wound, granulation tissue and epithelization. The measurement scale is of the Likert type, with five points, with 1 indicating the best condition of the wound and 5, the worst condition. The total score is obtained with the sum of all the items and can vary from 13 to 65 points, with the highest scores indicating the worst conditions of the wound. The items: size, depth, edges, and detachment should be scored with zero when the lesions are healed. The instrument contains two items: location and form - which are not part of the total score.
次要结局
未报告次要终点
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho
