Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly
Condition: Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

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?
    

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. On the first and
      fourth day of follow-up, a photographic record of the area affected by IAD will be taken and
      it will be assessed whether the participant has pain (verbal or numerical scale or PANAID
      scale) in the region affected by IAD during intimate intercourse. hygiene. Both groups will
      receive standardized topical treatment at the institution, according to the characteristics
      of the DAI and the participants of the Experimental Group will receive the application of
      low-intensity laser therapy in the area affected by the DAI for three days.

      Follow-up may be interrupted before four days 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 staff 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 if the participant is diagnosed with COVID-19.

      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.

      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.
    

Intervention name(s): Gentle intimate hygiene and skin protective barrier application - Persistent erythema with intact epidermis; Gentle intimate hygiene and skin protective barrier application - Erythema with signs of epidermis loss; Low Level Laser Therapy - Persistent erythema with intact epidermis; Low Level Laser Therapy - Erythema with signs of epidermis loss
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elderly; Urinary incontinence.; Fecal incontinence.; Diaper dermatitis.; Low intensity light therapy.