Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

Completed

• Conditions: Incontinence-associated Dermatitis; Diaper Rash; Pressure Ulcer; Irritant Contact Dermatitis
• Interventions: Procedure: Punch skin biopsy

• Registration Number: NCT03685929
• Lead Sponsor: University Ghent

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.

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Study Start: 2018-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combined lesion	Punch skin biopsy	Patients with pressure ulcer category II/III and incontinence-associated dermatitis category IIA at sacrum or trochanter
Pressure ulcers	Punch skin biopsy	Patients with pressure ulcers category II/III at sacrum or trochanter
Incontinence-associated dermatitis	Punch skin biopsy	Patients with incontinence-associated dermatitis category IIA at sacrum (or trochanter)

Primary Outcome Measures

Name	Time	Method
Histopathologic pattern	1 day	Characteristics of epidermis, dermis, and subcutis based on histopathologic examination
Prevalence of pressure ulcers and incontinence-associated dermatitis	1 day	Presence of pressure ulcers and/or incontinence-associated dermatitis based on photographs and patient characteristics

Secondary Outcome Measures

Name	Time	Method
Rate of agreement between visual and histopathologic diagnosis	1 day	Agreement between diagnosis of wound care experts (based on photographs), and diagnosis by skin pathologists (based on histopathologic examination)

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium