Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

Pressure Ulcer Clinical Trial

Official title:

Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685929
• Other study ID #: 2018/0946
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Diaper Rash
• Incontinence-associated Dermatitis
• Irritant Contact Dermatitis
• Pressure Ulcer
• Ulcer

Intervention

Procedure:
• Punch skin biopsy
Two punch biopsies will be performed in each patient, one at the border of the skin lesion, and one at the adjacent healthy skin. A disposable biopsy punch of 4 mm will be used. A biopsy punch is a small circular blade (like an apple corer) which is rotated into the skin to obtain a cylindrical specimen. Local anaesthesia will be applied and the circular wound will be closed by a single suture. Sutures will be removed after one week.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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:CD011627. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of pressure ulcers and incontinence-associated dermatitis	Presence of pressure ulcers and/or incontinence-associated dermatitis based on photographs and patient characteristics	1 day
Primary	Histopathologic pattern	Characteristics of epidermis, dermis, and subcutis based on histopathologic examination	1 day
Secondary	Rate of agreement between visual and histopathologic diagnosis	Agreement between diagnosis of wound care experts (based on photographs), and diagnosis by skin pathologists (based on histopathologic examination)	1 day

External Links

•   Website of the research group