Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Histopathologic pattern
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Skin infection at biopsy site
- •Medical contraindication to obtain a biopsy
- •End of life care
- •Not able to provide informed consent
结局指标
主要结局
Histopathologic pattern
时间窗: 1 day
Characteristics of epidermis, dermis, and subcutis based on histopathologic examination
Prevalence of pressure ulcers and incontinence-associated dermatitis
时间窗: 1 day
Presence of pressure ulcers and/or incontinence-associated dermatitis based on photographs and patient characteristics
次要结局
- Rate of agreement between visual and histopathologic diagnosis(1 day)
