Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Efficacy in the treatment of incontinence-associated dermatitis
研究概览
简要总结
Incontinence-associated dermatitis (IAD) is defined as skin inflammation resulting from prolonged exposure to feces and/or urine, found in individuals with urinary incontinence, fecal incontinence, or both. Currently, preventive and treatment measures with strong clinical evidence include gentle hygiene and application of barrier products. Justification: Low-Level Laser Therapy (LLLT) is used in the tissue repair process, due to its analgesic, anti-inflammatory and biomodulator effects, with improvement in the treatment of pressure injuries. In this way, would the use of LLLT bring better results associated with topical treatment for the management of IAD?
详细描述
This is a field study, analytical, interventionist, controlled clinical trial type, randomized, double-blind and with quantitative data analysis, with the aim of comparing the topical treatment of Incontinence-Associated Dermatitis in the elderly with the topical treatment associated with Low Intensity Laser Therapy. The study population will consist of elderly people with Incontinence-Associated Dermatitis admitted to a surgical and semi-intensive medical clinic of a private, tertiary, extra-sized hospital, located in the south zone of the city of São Paulo.
Participants will be divided initially by the characteristics of IAD: persistent erythema with intact epidermis and erythema with signs of epidermis loss. Subsequently, randomization will be performed using the REDCap platform and participants will be divided into Control Group and Experimental Group.
The Control Group will receive the conventional treatment and the Experimental Group will receive the conventional treatment associated with the application of Low Intensity Laser Therapy. The conventional treatment of patients belonging to both groups will be made available in the institutional protocol of the study site for the treatment of Incontinence-Associated Dermatitis, according to its characteristics of persistent erythema with intact epidermis or erythema with signs of epidermis loss.
Persistent erythema with intact epidermis: Perform intimate hygiene with warm water (to remove excess feces and urine), apply skin cleanser without rinsing to finish cleaning, apply a thin layer of Dexpanthenol (with each diaper change), apply polymeric solution spray once a day.
Erythema with signs of epidermis loss: Perform intimate hygiene with warm water (to remove excess feces and urine), apply a leave-in skin cleanser to finish cleaning, apply powdered hydrocolloid powder and remove excess. Afterwards, apply a polymeric spray solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Through the results of the verbal and numerical scale or PANAID obtained on the first and last day of follow-up, it will be verified whether or not there was an improvement in pain during intimate hygiene in the area affected by IAD.
With the results of the specialists' evaluations of the first and last day of follow-up, it will be verified whether or not there was an improvement in the characteristics of the IAD, verifying the effectiveness of the proposed treatment.
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly people who have Incontinence-Associated Dermatitis (persistent erythema with intact epidermis and erythema with signs of epidermal loss) admitted to the surgical medical clinic;
- •Elderly people who have Incontinence-Associated Dermatitis (persistent erythema with intact epidermis and erythema with signs of epidermal loss) admitted to the the semi intensive.
排除标准
- •Elderly with medical prescription for another proposed treatment for IAD that is not in the institutional protocol;
- •Elderly with change in behavior proposed by the nursing team during the study period;
- •Elderly in the final stage of life;
- •Elderly with some hemodynamic instability due to signs of progressive organ dysfunction and/or suspected deterioration of clinical conditions with need for transfer to intensive care during the study period;
- •Elderly newly diagnosed with cancer in need of transfer to oncology to start treatment during the study period; Elderly who have been newly diagnosed with COVID-19 and need to be transferred to the cohort area during the study period.
- •Elderly people using product for the treatment of dermatitis associated with incontinence incompatible with the application of low-intensity laser therapy.
结局指标
主要结局
Efficacy in the treatment of incontinence-associated dermatitis
时间窗: 4 days
Three specialist judges, stoma therapist nurses with more than five years of experience in stoma therapy, will evaluate the photographic records of the first and last day and will evaluate: the percentage of area affected by DAI, the percentage of area affected by erythema, the percentage of area affected by erosion, percentage of area affected by denudation/ulceration, percentage of area affected by papules/satellite lesions, percentage of area affected by maceration. The evaluators will not know if the photo is from the first or the last day of treatment, they will not know the proposed treatment and they will not know about the evaluation of the other evaluator.With the results of the specialists' evaluations of the first and last day of follow-up, it will be verified whether or not there was an improvement in the characteristics of the IAD, verifying the effectiveness of the proposed treatment.
Pain assessment in the treatment of incontinence-associated dermatitis
时间窗: 4 days
Pain assessment can be performed with the Numeric Visual Scale with scores from 0 to 10 for conscious participants who will be able to report their pain score. In elderly people with cognitive impairment, periods of confusion and understanding, the Pain Assessment in Advanced Dementia (PAINAD) scale will be used, which has pain intensity from 0 to 10. Pain assessment will be performed on the first and last day of follow-up, during intimate hygiene, which is the right time to measure pain, by the principal investigator.
次要结局
未报告次要终点
研究者
Ana Lúcia de Araújo Grana
Principal Investigador
Hospital Israelita Albert Einstein