Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly (NCT05699122) | Clinical Trial Compass
CompletedNot Applicable
Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly
Brazil16 participantsStarted 2023-02-01
Plain-language summary
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?
Who can participate
Age range
60 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy in the treatment of incontinence-associated dermatitis
Timeframe: 4 days
2
Pain assessment in the treatment of incontinence-associated dermatitis