Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly

Sponsor

Hospital Israelita Albert Einstein (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05699122

Collaborator

(none)

Enrollment

Arms

2.9

Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Dermatitis	Other: Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermis Other: Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis loss Other: Low Level Laser Therapy - Persistent erythema with intact epidermis Other: Low Level Laser Therapy - Erythema with signs of epidermis loss	N/A

Detailed Description

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.

For the application of LLLT, laser therapy equipment will be used with a wavelength of 660nm and 808nm, power of 100mW, with category 3R and within the institution's calibration period.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.

Study participants will be followed up with daily visits for four days, starting from the beginning of the proposed treatment, and follow-up may end before the end of the four-day period, in the following cases: if the IAD is resolved, if the participant is discharged from the hospital , if the participant is transferred to intensive care or oncology during the study period, if the nursing team changes the conduct of the proposed treatment, if the physician changes the proposed treatment or if the participant refuses to remain in the study or the participant is diagnosed with COVID-19.

Participants will be monitored for four days. Both groups will receive topical treatment according to the characteristics of the DAI and participants in the Experimental Group will receive low-level laser therapy for three days. On the first and fourth day of follow-up, a photographic record of the area affected by IAD will be taken.

On the first and fourth day of follow-up, it will be evaluated whether the participant has pain in the region affected by IAD.

The evaluation of the first and last day of treatment will be carried out through the answers of the pain evaluation by the verbal and numerical scale or PANAID to verify if there was improvement or not of the pain in the area affected by the IAD.

Three expert judges, with more than five years of experience in stomatherapy, will evaluate the photographic record of the first and last day of treatment. The photographic records will be made available through the REDCap platform and the evaluators will not know which treatment was proposed to the participants and will not know about the evaluation of the other evaluator. A Likert scale from 0 to 10 (0=no improvement and 10= complete improvement) will be used to verify the effectiveness of the proposed treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The Principal Investigator will assess pain on the first and fourth day of follow-up and will be solely responsible for applying low-level laser therapy to participants in the experimental group or simulating the application to participants in the control group. The evaluation of the photographic records using the Likert Scale will be carried out by three judges who will not know which group the participant belonged to.

Primary Purpose:

Treatment

Official Title:

Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly

Anticipated Study Start Date :

Jan 16, 2023

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: The Control Group - Persistent erythema with intact epidermis The Control Group - Persistent erythema with intact epidermis	Other: Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermis 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.
Experimental: The Experimental Group - Persistent erythema with intact epidermis The Experimental Group - Persistent erythema with intact epidermis	Other: Low Level Laser Therapy - Persistent erythema with intact epidermis 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.
Active Comparator: The Control Group - Erythema with signs of epidermis loss The Control Group - Erythema with signs of epidermis loss	Other: Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis loss 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.
Experimental: The Experimental Group - Erythema with signs of epidermis loss The Experimental Group - Erythema with signs of epidermis loss	Other: Low Level Laser Therapy - Erythema with signs of epidermis loss 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.

Outcome Measures

Primary Outcome Measures

Efficacy in the treatment of incontinence-associated dermatitis [4 days]
Three expert judges will evaluate the photographic record of the first and last day of treatment and using a Likert scale from 0 to 10 (0=no improvement and 10=complete improvement) the effectiveness of the proposed treatment will be evaluated. The judges will not know which groups the participants belonged to and will not know the other rater's assessment.
Pain assessment in the treatment of incontinence-associated dermatitis [4 days]
Pain assessment can be performed with the Visual Analog Scale (VAS) 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.