NCT05471180

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Incontinence Associated Dermatitis
• Diaper Rash
• Photobiomodulation Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-20
• Primary completion: 2022-12-20
• Completion: 2023-01-20
• First posted: 2022-07-22
• Last updated: 2023-06-29

Locations

1 site across 1 country: Brazil