Adjuvant Effect of Photobiomodulation in the Treatment of Incontinence-associated Dermatitis in Adults
NCT ID: NCT05471180
Last Updated: 2023-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-08-20
2023-01-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
protective spray film
Skincare will be maintained with 3M Cavilon ® Cleansing Solution and the use of 3M Cavilon ® Protective Spray Film.
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.
protective spray film
Skincare will be maintained with 3M Cavilon ® Cleansing Solution and the use of 3M Cavilon ® Protective Spray Film.
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.
Interventions
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protective spray film
Skincare will be maintained with 3M Cavilon ® Cleansing Solution and the use of 3M Cavilon ® Protective Spray Film.
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.
Eligibility Criteria
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Inclusion Criteria
* Individuals of both male and female sex
* Individuals aged 21 or over
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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Adriana da Silva Magalhaes
UNKNOWN
University of Nove de Julho
OTHER
Responsible Party
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Anna Carolina Ratto Tempestini Horliana
PhD, Postgraduate program professor
Principal Investigators
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Anna Carolina R Horliana, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nove de Julho
Locations
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Anna Carolina R.T. Horliana
São Paulo, São Paulo, Brazil
Countries
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References
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Bliss DZ, Funk T, Jacobson M, Savik K. Incidence and Characteristics of Incontinence-Associated Dermatitis in Community-Dwelling Persons With Fecal Incontinence. J Wound Ostomy Continence Nurs. 2015 Sep-Oct;42(5):525-30. doi: 10.1097/WON.0000000000000159.
Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, Kennedy-Evans KL, Logan S, Ratliff CR. Moisture-associated skin damage: overview and pathophysiology. J Wound Ostomy Continence Nurs. 2011 May-Jun;38(3):233-41. doi: 10.1097/WON.0b013e318215f798.
Seifi B, Jalali S, Heidari M. Assessment Effect of Breast Milk on Diaper Dermatitis. Dermatol Reports. 2017 Mar 13;9(1):7044. doi: 10.4081/dr.2017.7044. eCollection 2017 Mar 13.
Gray M, Bliss DZ, Doughty DB, Ermer-Seltun J, Kennedy-Evans KL, Palmer MH. Incontinence-associated dermatitis: a consensus. J Wound Ostomy Continence Nurs. 2007 Jan-Feb;34(1):45-54; quiz 55-6. doi: 10.1097/00152192-200701000-00008.
Woo KY, Beeckman D, Chakravarthy D. Management of Moisture-Associated Skin Damage: A Scoping Review. Adv Skin Wound Care. 2017 Nov;30(11):494-501. doi: 10.1097/01.ASW.0000525627.54569.da.
Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
Beele H, Smet S, Van Damme N, Beeckman D. Incontinence-Associated Dermatitis: Pathogenesis, Contributing Factors, Prevention and Management Options. Drugs Aging. 2018 Jan;35(1):1-10. doi: 10.1007/s40266-017-0507-1.
Black JM, Gray M, Bliss DZ, Kennedy-Evans KL, Logan S, Baharestani MM, Colwell JC, Goldberg M, Ratliff CR. MASD part 2: incontinence-associated dermatitis and intertriginous dermatitis: a consensus. J Wound Ostomy Continence Nurs. 2011 Jul-Aug;38(4):359-70; quiz 371-2. doi: 10.1097/WON.0b013e31822272d9.
Kottner J, Blume-Peytavi U, Lohrmann C, Halfens R. Associations between individual characteristics and incontinence-associated dermatitis: a secondary data analysis of a multi-centre prevalence study. Int J Nurs Stud. 2014 Oct;51(10):1373-80. doi: 10.1016/j.ijnurstu.2014.02.012. Epub 2014 Feb 23.
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Junkin J, Selekof JL. Beyond "diaper rash": Incontinence-associated dermatitis: does it have you seeing red? Nursing. 2008 Nov;38(11 Suppl):56hn1-10; quiz 56hn10-1. doi: 10.1097/01.NURSE.0000341725.55531.e2.
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Other Identifiers
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Dermatite
Identifier Type: -
Identifier Source: org_study_id
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