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

NCT05471180 | Withdrawn

• 1 other identifier: Dermatite
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incontinence Associated Dermatitis; Diaper Rash; Photobiomodulation Therapy

Keywords

Incontinence associated dermatitis; Diaper Rash; Photobiomodulation therapy; Laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Size of the lesion measured by its area

  seventh day

• Photographed for evaluation

  seventh day

• Ghent Global IAD Categorization Tool scale

  seventh day

• Pain assessment (Visual Analog Scale /Behavioral Pain Scale/ Pain Assessment in Advanced Dementia)

  seventh day

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Experimental group

EXPERIMENTAL

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; Device: photobiomodulation therapy

Interventions

protective spray film OTHER

Skincare will be maintained with 3M Cavilon ® Cleansing Solution and the use of 3M Cavilon ® Protective Spray Film.

Control group; Experimental group

photobiomodulation therapy DEVICE

application in 8 points of the affected perineum region, these applications will occur 1 x a day every 24 hours for three days.

Experimental group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead
• Adriana da Silva Magalhaes: collaborator

Study Sites (1)

Anna Carolina R.T. Horliana

São Paulo, São Paulo, 11030-480, Brazil

Location

Related Publications (20)

• 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.

  PMID: 26336048 RESULT

• 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.

  PMID: 21490547 RESULT

• 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.

  PMID: 28626535 RESULT

• 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.

  PMID: 17228207 RESULT

• 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.

  PMID: 29049257 RESULT

• 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.

  PMID: 27841440 RESULT

• 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.

  PMID: 29243033 RESULT

• 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.

  PMID: 21747256 RESULT

• 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.

  PMID: 24636666 RESULT

• 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, Romanelli M, Ruppert S, Schoonhoven L, Smet S, Smith C, Steininger A, Stockmayr M, Van Damme N, Voegeli D, Van Hecke A, Verhaeghe S, Woo K, Kottner J. Towards an international language for incontinence-associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent Global IAD Categorization Tool (GLOBIAD) in 30 countries. Br J Dermatol. 2018 Jun;178(6):1331-1340. doi: 10.1111/bjd.16327. Epub 2018 Apr 19.

  PMID: 29315488 RESULT

• 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.

  PMID: 19020456 RESULT

• 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. English, Portuguese.

  PMID: 28380152 RESULT

• 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 caregiver behavior. Pediatr Dermatol. 2020 Jan;37(1):130-136. doi: 10.1111/pde.14047. Epub 2019 Dec 2.

  PMID: 31793090 RESULT

• 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.

  PMID: 30506880 RESULT

• 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.

  PMID: 24082586 RESULT

• 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/s1678-77572012000600002.

  PMID: 23329239 RESULT

• 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.

  PMID: 34357037 RESULT

• 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.

  PMID: 28144431 RESULT

• 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.

  PMID: 21172691 RESULT

• 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.

  PMID: 24049929 RESULT

MeSH Terms

Conditions

Diaper Rash

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Anna Carolina R Horliana, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the researcher with a degree in Nursing, who will be responsible for carrying out the treatments (opening the envelopes of randomization), will know which treatment will be assigned to each participant (with photobiomodulation or its simulation). The researcher will not be involved in the assessment of injuries.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Postgraduate program professor

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2022
• First Posted: July 22, 2022
• Study Start: August 20, 2022
• Primary Completion: December 20, 2022
• Study Completion: January 20, 2023
• Last Updated: June 29, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 month
• Access Criteria: everyone

Locations

BR (1)