Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis
NCT ID: NCT03685929
Last Updated: 2021-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2018-10-01
2019-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Pressure ulcers
Patients with pressure ulcers category II/III at sacrum or trochanter
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.
Incontinence-associated dermatitis
Patients with incontinence-associated dermatitis category IIA at sacrum (or trochanter)
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.
Combined lesion
Patients with pressure ulcer category II/III and incontinence-associated dermatitis category IIA at sacrum or trochanter
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Medical contraindication to obtain a biopsy
* End of life care
* Not able to provide informed consent
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
University Ghent
OTHER
Responsible Party
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Principal Investigators
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Sofie De Schepper
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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References
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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.
Related Links
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Website of the research group
Other Identifiers
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2018/0946
Identifier Type: -
Identifier Source: org_study_id