Clinical trial NCT03685929: Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis
Official title: Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcer
Incontinence-associated Dermatitis
Irritant Contact Dermatitis
Diaper Rash
Keywords: Pressure ulcer
Incontinence-associated dermatitis
Histopathology
Ischemia
Irritation
Prevention
Tissue
Skin
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2018-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted on following wards of a university hospital

* Pneumology
* Gastroenterology
* Endocrinology
* Nephrology
* Neurology
* Geriatrics
* Gastrointestinal surgery

Brief summary: This study aims to identify differences and similarities between superficial pressure ulcers (category II and III) and incontinence-associated dermatitis (category IIA) at tissue level.

Skin biopsies will be obtained from 30 patients with pressure ulcers (n = 10), incontinence-associated dermatitis (n = 10), and combined lesions (n = 10).

The results from the histopathologic examination will be compared with the clinical diagnosis by wound care experts, which will be based on photographs and relevant patients' characteristics.

Detailed description: Despite current preventive strategies, prevalence of pressure ulcers and incontinence-associated dermatitis (IAD) is still estimated at 5.9-6.9% in hospitalised patients, and 5.0-5.9 in home care patients. Both skin conditions may occur in the same body region but are considered as separate entities, based on differences in etiology.

At tissue level, it is assumed that pressure ulcers are characterised by ischemia and tissue deformation. In contrast, IAD is assumed to be characterised by an irritative pattern. These assumptions are reflected in current preventive strategies. However, a small scale study, performed by Houwing et al. (2007), described the additional presence of an ischemic pattern in patients with IAD. More insights into the histopathologic pattern of pressure ulcers and IAD is needed to optimise current preventive strategies.

Tha aim of this study is to compare superficial pressure ulcers (category II and III) and IAD (category IIA) at tissue level.

A prospective interventional study will be performed during which skin biopsies (punch biopsies) will be collected from 30 incontinent patients. In each patient patient, two punch skin biopsies will be performed, one at the border of the skin lesion and one at the adjacent healthy skin. Sections from the biopsies will be stained with hematoxiline and eosine and examined by two independently working, blinded skin pathologists. In addition, photographs from the skin lesions will be analysed by 10 national and international wound care experts to promote correct diagnosis. Finally, findings from the histopathologic examination will be compared with the clinical diagnoses based on photographs.

Eligibility criteria: Inclusion Criteria:

* Incontinent for urine, stool, or both
* Superficial pressure ulcer (category II or III) and/or incontinence-associated dermatitis (category IIA)
* Expected length of stay of 7 days following punch skin biopsy

Exclusion Criteria:

* Skin infection at biopsy site
* Medical contraindication to obtain a biopsy
* End of life care
* Not able to provide informed consent

Primary outcomes:
measure: Prevalence of pressure ulcers and incontinence-associated dermatitis
timeFrame: 1 day
measure: Histopathologic pattern
timeFrame: 1 day
Secondary outcomes:
measure: Rate of agreement between visual and histopathologic diagnosis
timeFrame: 1 day
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Sofie De Schepper
role: PRINCIPAL_INVESTIGATOR
References:
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. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.