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

Diaper Rash Clinical Trial

— DAI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05471180
• Other study ID #: Dermatite
• Status: Withdrawn
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: July 2022
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Diaper Rash
• Incontinence Associated Dermatitis
• Photobiomodulation Therapy

Intervention

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.

Locations

Country	Name	City	State
Brazil	Anna Carolina R.T. Horliana	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Adriana da Silva Magalhaes

Country where clinical trial is conducted

Brazil, 

References & Publications (20)

Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52. — View Citation

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. Cochra — View Citation

Beeckman D, Van den Bussche K, Alves P, Arnold Long MC, Beele H, Ciprandi G, Coyer F, de Groot T, De Meyer D, Deschepper E, Dunk AM, Fourie A, Garcia-Molina P, Gray M, Iblasi A, Jelnes R, Johansen E, Karadag A, Leblanc K, Kis Dadara Z, Meaume S, Pokorna A — View Citation

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. — View Citation

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):359-7 — View Citation

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. — View Citation

Burdall O, Willgress L, Goad N. Neonatal skin care: Developments in care to maintain neonatal barrier function and prevention of diaper dermatitis. Pediatr Dermatol. 2019 Jan;36(1):31-35. doi: 10.1111/pde.13714. Epub 2018 Dec 2. — View Citation

Carr AN, DeWitt T, Cork MJ, Eichenfield LF, Folster-Holst R, Hohl D, Lane AT, Paller A, Pickering L, Taieb A, Cui TY, Xu ZG, Wang X, Brink S, Niu Y, Ogle J, Odio M, Gibb RD. Diaper dermatitis prevalence and severity: Global perspective on the impact of ca — View Citation

Chianca TC, Goncales PC, Salgado PO, Machado BO, Amorim GL, Alcoforado CL. Incontinence-associated dermatitis: a cohort study in critically ill patients. Rev Gaucha Enferm. 2017 Mar 30;37(spe):e68075. doi: 10.1590/1983-1447.2016.esp.68075. Erratum In: Rev — View Citation

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.0b013e318 — View Citation

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. — View Citation

Gushiken LFS, Beserra FP, Bastos JK, Jackson CJ, Pellizzon CH. Cutaneous Wound Healing: An Update from Physiopathology to Current Therapies. Life (Basel). 2021 Jul 7;11(7):665. doi: 10.3390/life11070665. — View Citation

Hashmi JT, Huang YY, Osmani BZ, Sharma SK, Naeser MA, Hamblin MR. Role of low-level laser therapy in neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S292-305. doi: 10.1016/j.pmrj.2010.10.013. — View Citation

Iryanov YM. Influence of Laser Irradiation Low Intensity on Reparative Osteogenesis and Angiogenesis Under Transosseous Osteosynthesis. J Lasers Med Sci. 2016 Summer;7(3):134-138. doi: 10.15171/jlms.2016.23. Epub 2016 Jul 18. — View Citation

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. — View Citation

Kajagar BM, Godhi AS, Pandit A, Khatri S. Efficacy of low level laser therapy on wound healing in patients with chronic diabetic foot ulcers-a randomised control trial. Indian J Surg. 2012 Oct;74(5):359-63. doi: 10.1007/s12262-011-0393-4. Epub 2012 Apr 11 — View Citation

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 — View Citation

Maia ML, Bonjardim LR, Quintans Jde S, Ribeiro MA, Maia LG, Conti PC. Effect of low-level laser therapy on pain levels in patients with temporomandibular disorders: a systematic review. J Appl Oral Sci. 2012 Nov-Dec;20(6):594-602. doi: 10.1590/s1678-77572 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T- Healing rate of IAD lesion in 7 days	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	Size of the lesion measured by its area	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
Secondary	Photographed for evaluation	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
Secondary	Ghent Global IAD Categorization Tool scale	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
Secondary	Pain assessment (Visual Analog Scale /Behavioral Pain Scale/ Pain Assessment in Advanced Dementia)	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