Adjuvant Effect of Photobiomodulation in the Treatment of Incontinence-associated Dermatitis in Adults (DAI)

June 27, 2023 updated by: Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho

Adjuvant Effect of Photobiomodulation in the Treatment of Incontinence-associated Dermatitis in Adults - a Randomized Controlled Clinical Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 11030-480
        • Anna Carolina R.T. Horliana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Control group (n=39) - 3M Cavilon ® protective spray film + simulation of the use of laser (placebo) - after cleaning the skin, the pain scale will be applied and after application of FBM in the same points of the group that will undergo irradiation. To mimic the action of the laser, the BIP noise will be recorded and its activation will be done by the nursing employee who provides the care, after simulating the use of the laser, the use of the 3M Cavilon ® protective spray film will be applied. The application of the laser will be immediate in 8 points of the perineum region in the areas that present lesions, these applications will occur 1 x a day every 24 hours for three consecutive days. Skincare will be maintained with 3M Cavilon ® Cleansing Solution and the use of 3M Cavilon ® Protective Spray Film. A photographic record of the lesion will be made on days 0 and 3 of treatment and after 2 days after treatment to monitor the recovery of the IAD
Other: protective spray film
Skincare will be maintained with 3M Cavilon ® Cleansing Solution and the use of 3M Cavilon ® Protective Spray Film.
Experimental: Experimental group
Experimental group (n= 39) 3M Cavilon ® protective spray film + FBM - skin cleaning and pain scale application will be performed and after laser application in 8 points of the affected perineum region, these applications will occur 1 x a day every 24 hours for three days. Skincare will be maintained with 3M Cavilon ® Cleansing Solution and the use of 3M Cavilon ® Protective Spray Film. The photographic record of the lesion will be performed on days 0 and 3, 5 and 7 days of treatment. To monitor the participants and observe the recovery and obtainment of skin healing. It will be used the Globaid tool that will be applied in both groups.
Other: protective spray film
Skincare will be maintained with 3M Cavilon ® Cleansing Solution and the use of 3M Cavilon ® Protective Spray Film.
Device: photobiomodulation therapy
application in 8 points of the affected perineum region, these applications will occur 1 x a day every 24 hours for three days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T- Healing rate of IAD lesion in 7 days
Time Frame: 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.
seventh day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of the lesion measured by its area
Time Frame: seventh day
Size of the lesion measured by its area - A measurement of the lesion area will be made before the start of treatment on days 0 and 3 and day 7. To evaluate the lesion, the measurement in its greatest length and width will be considered, the measurements will be noted, and, later, multiplied one measurement by the other to obtain the area in cm²
seventh day
Photographed for evaluation
Time Frame: seventh day
The lesions will be photographed for evaluation on the 0th, 3rd, and 7th day and using the ImageJ® software "USA National Institutes of Health, Bethesda, MD ", analyses of the edge of each lesion will be performed, manually delimited with the mouse and the entire lesion will be circled for the calculation of the area, quantifying the total area of the lesions by the delimitation of the edges and, later, the dermatitis lesion index (ILD) will be calculated = (Initial area - Final area / Initial area), where ILD= 1 (100%) represents total revitalization; ILD=0 with no signs of revitalization; ILD>0 reductions and ILD. The computerized area of the lesion will be calculated by the scale in centimeters of the millimeter ruler photographed next to each lesion. This evaluation will be carried out by the same examiner who was not aware of the identification of the samples.
seventh day
Ghent Global IAD Categorization Tool scale
Time Frame: seventh day
The lesions will be photographed in a standardized way and will be evaluated by an experienced calibrated researcher, using the instrument for the evaluation of the Ghent Global IAD Categorization Tool scale from Globaid that characterizes the category of the lesion, individuals who do not have category 1 (1A) and category 2 (2A), demonstrate healing and wound healing. There are no signs of a cure if the category remains 1-(1A) and 2(2A). Individuals who evolve in category 1 (2B) and in category 2 (2B), will be considered as signs of severity, according to the scale and exit criteria of the study.
seventh day
Pain assessment (Visual Analog Scale /Behavioral Pain Scale/ Pain Assessment in Advanced Dementia)
Time Frame: seventh day

Pain assessment with the pain scale VAS with a score from 0 to 10 that will be applied to conscious participants who can inform the score of their pain,

In intubated participants the Behavioral Pain Scale - BPS will be used with scores pain 0 to 12 in participants on mechanical ventilation, evaluating the following parameters: Facial expression, body movements, and Tolerance to mechanical ventilation the scale allows defining the pain intensity between 3 (no pain) and 12 (the greatest pain intensity).

In adults with cognitive impairment, periods of confusion and dementia, the Pain Assessment in Advanced Dementia - PAINAD scale will be used, which has pain intensity from 0 to 10.The application of the scale will occur during intimate hygiene. Pain assessment will take place during intimate hygiene, which is the appropriate time to measure pain, this assessment will be done until the end of the intervention.
seventh day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Collaborators

Adriana da Silva Magalhaes

Investigators

  • Principal Investigator: Anna Carolina R Horliana, PhD, University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2022

Primary Completion (Estimated)

December 20, 2022

Study Completion (Estimated)

January 20, 2023

Study Registration Dates

First Submitted

July 16, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dermatite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We are planning to publish the protocol

IPD Sharing Time Frame

1 month

IPD Sharing Access Criteria

everyone

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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