- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685929
Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium
- Ghent University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients admitted on following wards of a university hospital
- Pneumology
- Gastroenterology
- Endocrinology
- Nephrology
- Neurology
- Geriatrics
- Gastrointestinal surgery
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pressure ulcers
Patients with pressure ulcers category II/III at sacrum or trochanter
|
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)
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 day
|
Histopathologic pattern
Time Frame: 1 day
|
Characteristics of epidermis, dermis, and subcutis based on histopathologic examination
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of agreement between visual and histopathologic diagnosis
Time Frame: 1 day
|
Agreement between diagnosis of wound care experts (based on photographs), and diagnosis by skin pathologists (based on histopathologic examination)
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sofie De Schepper, University Hospital, Ghent
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/0946
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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