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Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

U

University Ghent

Status

Completed

Conditions

Irritant Contact Dermatitis
Incontinence-associated Dermatitis
Diaper Rash
Pressure Ulcer

Treatments

Procedure: Punch skin biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT03685929
2018/0946

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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