Skip to main content
Clinical Trials/NCT03685929
NCT03685929CompletedNot Applicable

Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

University Ghent1 site in 1 country30 target enrollmentStarted: October 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Histopathologic pattern

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Histopathologic pattern

Time Frame: 1 day

Characteristics of epidermis, dermis, and subcutis based on histopathologic examination

Prevalence of pressure ulcers and incontinence-associated dermatitis

Time Frame: 1 day

Presence of pressure ulcers and/or incontinence-associated dermatitis based on photographs and patient characteristics

Secondary Outcomes

  • Rate of agreement between visual and histopathologic diagnosis(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Histopathological Comparison Between... | Clinical Trial