Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly
1 other identifier
interventional
16
1 country
1
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedSeptember 13, 2023
September 1, 2023
5 months
January 2, 2023
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy in the treatment of incontinence-associated dermatitis
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.
4 days
Pain assessment in the treatment of incontinence-associated dermatitis
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.
4 days
Study Arms (4)
The Control Group - Persistent erythema with intact epidermis
ACTIVE COMPARATORThe Control Group - Persistent erythema with intact epidermis
The Experimental Group - Persistent erythema with intact epidermis
EXPERIMENTALThe Experimental Group - Persistent erythema with intact epidermis
The Control Group - Erythema with signs of epidermis loss
ACTIVE COMPARATORThe Control Group - Erythema with signs of epidermis loss
The Experimental Group - Erythema with signs of epidermis loss
EXPERIMENTALThe Experimental Group - Erythema with signs of epidermis loss
Interventions
Follow-up will be for 4 days, current treatment will be carried out with: 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 spray solution once a day.
Follow-up will be for 4 days, current treatment will be carried out with: Perform intimate hygiene with warm water (to remove excess feces and urine), applying a leave-in skin cleanser to finish cleaning, applying powdered hydrocolloid powder and removing excess. Afterwards, apply a polymeric spray solution.
Follow-up will be for 4 days, current treatment will be carried out with: 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 spray solution once a day. It will be associated with the application of Low Intensity Laser Therapy. The entire area affected by DAI will be irradiated with LBI at 1 Joule (J) of energy and with a wavelength of 660nm and 1J with a wavelength of 808nm, which will be applied simultaneously, with a radiance of 20J/cm2 per point, the distance between the stitches will be 1cm long and the application of LLLT will be performed every 24 hours.
Follow-up will be for 4 days, current treatment will be carried out with: Perform intimate hygiene with warm water (to remove excess feces and urine), applying a leave-in skin cleanser to finish cleaning, applying powdered hydrocolloid powder and removing excess. Afterwards, apply a polymeric spray solution. It will be associated with the application of Low Intensity Laser Therapy. The entire area affected by DAI will be irradiated with LBI at 1 Joule (J) of energy and with a wavelength of 660nm and 1J with a wavelength of 808nm, which will be applied simultaneously, with a radiance of 20J/cm2 per point, the distance between the stitches will be 1cm long and the application of LLLT will be performed every 24 hours.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Israelita Albert Einstein
São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigador
Study Record Dates
First Submitted
January 2, 2023
First Posted
January 26, 2023
Study Start
February 1, 2023
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share