Adjuvant Effect of Photobiomodulation in the Treatment of Incontinence-associated Dermatitis in Adults - a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- T- Healing rate of IAD lesion in 7 days
研究概览
简要总结
Incontinence-associated dermatitis (IAD) is an inflammation of the skin that occurs as a result of urine or feces contact on the perineal or perigenital region in adults. Lesions are typically located in the convex regions covered by diapers. The perineal region is the most affected, bringing pain and discomfort to the participant. The prevention and treatment of IAD must essentially follow two interventions: the control of incontinence/dampness and the implementation of a structured regimen of perineal care, seeking results for the restoration of skin integrity. Therefore, the gold standard for the treatment of IAD is skin hygiene, moisture control, and the use of a skin protector to restore skin integrity. Photobiomodulation has been used with excellent results in restoring skin integrity in acute and chronic wounds, but so far it has not been tested for IAD. To evaluate the effect of photobiomodulation in the treatment of incontinence-associated dermatitis in adults. A total of 78 with participant who developed lesions that present erythema with intact skin and erythema with loss of continuity, resulting from IAD, will be included in the study. Participants will be randomly divided into 2 groups: Control group use of liquid protective film in spray + FBM simulation (placebo), Experimental group (n=39) - use of liquid protective film in spray + FBM. FBM will be performed with a 660 nm 100mW diode laser, 2 J per point, in 8 points and radiant exposure of 707 J/cm2. FBM will be applied once a day every 24 hours for 3 days in a row. Both groups will continue with standard daily skin care and diaper changes every 3 hours. The primary endpoint was chosen for the 7-day IAD lesion cure rate study. A photographic record of the lesion area and measurements will be performed using a disposable ruler with the participant in a lithotomous position on the days of the evaluations. For the classification and characterization of the severity of IAD, the Ghent Global IAD Categorization tool will be applied. In addition, the size of the area will be analyzed using ImageJ software program. For pain assessment, the visual analog scale will be used in conscious participants and the BPS scale in participants with cognitive impairment and who are intubated. All outcomes will be evaluated at baseline, at 24 hours, 3 days, and 7 days.
详细描述
Incontinence-associated dermatitis (IAD) is an inflammation of the skin that occurs as a result of urine or feces contact on the perineal or perigenital region in adults. Lesions are typically located in the convex regions covered by diapers. The perineal region is the most affected, bringing pain and discomfort to the participant. The prevention and treatment of IAD must essentially follow two interventions: the control of incontinence/dampness and the implementation of a structured regimen of perineal care, seeking results for the restoration of skin integrity. Therefore, the gold standard for the treatment of IAD is skin hygiene, moisture control, and the use of a skin protector to restore skin integrity. Photobiomodulation has been used with excellent results in restoring skin integrity in acute and chronic wounds, but so far it has not been tested for IAD.
Materials and methods
A controlled, randomized, and blinded clinical study will be carried out on participants hospitalized in the Intensive Care sector, oncology, and coronary care unit of Hcor Associação Beneficente Síria. A total of 78 participants who developed lesions that present erythema with intact skin and erythema with loss of continuity, resulting from IAD, will be included in the study. Participants will be randomly divided into 2 groups: Control group (n=39) - use of liquid protective film in spray + FBM simulation (placebo), Experimental group (n=39) - use of liquid protective film in spray + FBM. FBM will be performed with a 660 nm 100mW diode laser, 2 J per point, in 8 points and radiant exposure of 707 J/cm2. FBM will be applied once a day every 24 hours for 3 days in a row. Both groups will continue with standard daily skin care and diaper changes every 3 hours. The primary endpoint was chosen for the 7-day IAD lesion cure rate study. A photographic record of the lesion area and measurements will be performed using a disposable ruler with the participant in a lithotomous position on the days of the evaluations. For the classification and characterization of the severity of IAD, the Ghent Global IAD Categorization tool will be applied. In addition, the size of the area will be analyzed using ImageJ software program. Pain will be assessed using a pain scale and a satisfaction questionnaire. All outcomes will be evaluated at baseline, at 24 hours, 3 days, and 7 days.
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
Only the researcher with a degree in Nursing, who will be responsible for carrying out the treatments (opening the envelopes of randomization), will know which treatment will be assigned to each participant (with photobiomodulation or its simulation). The researcher will not be involved in the assessment of injuries.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants or legal guardians who accept and fulfill the inclusion criteria for this study will sign the Free and Informed Consent Term (ICF) for authorization to participate in the study
- •Adult subjects exposed to wet urine/stool or both, who have erythema in the perineal region with persistent erythema and skin loss according to the Ghent Global IAD Categorization Tool severity characterization scale in category 1 (1A) and category 2 (2A), without signs of infection
- •Individuals of both male and female sex
- •Individuals aged 21 or over
排除标准
- •Individuals who do not have dermatitis in the perineal region, who have dermatitis
- •Individuals classified by the Ghent Global IAD Categorisation Tool scale in Category 1-B who have persistent erythema with clinical signs of infection and Category 2-B) with skin loss with clinical signs of infection in the perineal region
- •Instability such as arterial hypotension, respiratory discomfort that cannot be mobilized to perform the treatment of the lesion. Lesions in the perineal region with the presence of infection that requires the use of antibiotics, topical antifungals
- •Individuals with serious injuries who benefit from treatments that will not be part of the conventional protocol
- •Individuals who are pregnant
- •Severity of injuries and signs of infections
- •Individuals with skin lesions such as herpes in the perineal region
- •Individuals with pressure injuries existing in the gluteal regions
结局指标
主要结局
T- Healing rate of IAD lesion in 7 days
时间窗: seventh day
The participant will be evaluated by a calibrated member who will evaluate the participant with Globaid until the 7th day in which the lesion is expected to heal.
次要结局
- Pain assessment (Visual Analog Scale /Behavioral Pain Scale/ Pain Assessment in Advanced Dementia)(seventh day)
- Ghent Global IAD Categorization Tool scale(seventh day)
- Size of the lesion measured by its area(seventh day)
- Photographed for evaluation(seventh day)
研究者
Anna Carolina Ratto Tempestini Horliana
PhD, Postgraduate program professor
University of Nove de Julho