Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

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.

Official Title
-----------------
Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

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

Intervention / Treatment
-----------------
* Procedure: Punch skin biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pressure ulcers<br>Patients with pressure ulcers category II/III at sacrum or trochanter | Procedure: Punch skin biopsy<br>* 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.<br>|
| Incontinence-associated dermatitis<br>Patients with incontinence-associated dermatitis category IIA at sacrum (or trochanter) | Procedure: Punch skin biopsy<br>* 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.<br>|
| Combined lesion<br>Patients with pressure ulcer category II/III and incontinence-associated dermatitis category IIA at sacrum or trochanter | Procedure: Punch skin biopsy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Histopathologic pattern | 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 | Agreement between diagnosis of wound care experts (based on photographs), and diagnosis by skin pathologists (based on histopathologic examination) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tissue, Pressure ulcer, Incontinence-associated dermatitis, Histopathology, Ischemia, Irritation, Prevention, Skin