Role of Estrogens and Their Receptors in the Development of Skin Tears Evaluated in Residents of Residential Care Facilities.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Correlation Between Estrogen and Skin Tears
研究概览
简要总结
Background: Skin tears (ST) or "laceration injuries" or "flap wounds" are injuries that are often found in residents of residential care facilities (RCFs). STs were first defined by Payne and Martin in 1993 as traumatic wounds, located mainly in the upper limbs, caused by "shearing, friction or mechanisms combined with the consequent separation of layers of skin. Skin Tears can cause psychological problems for the patient and represent an economic problem with important repercussions on both the patient and the community. The etiology suggests that the physiological changes of the skin related to old age, together with comorbidity, are among the main risk factors for their onset.
The precise data on the phenomenon are not many, but it is estimated that STs are much more frequent than the same pressure ulcers, observing prevalence rates in RCFs around 40% Therefore, there are several risk factors hypothesized so far. Much evidence has correlated, in various physiological or pathological conditions, the role of estrogens with the functions and aging of the skin.
Objectives: The project will develop on the analysis of populations of residents from RCFs belonging to the national territory. Two populations of residents cared in the RCF will be recruited. A group of subjects suffering from skin tears (group A) and a control group of subjects without skin tears (group B). The inclusion of patients in both groups will take place through a simple randomization procedure. Group A patients will be staged according to the STAR classification for skin tears. For each group a peripheral venous blood sample will be taken (to measure the levels of estrone and estradiol) and a skin biopsy will be performed in order to measure estrogen receptors (ERs) expression. A data collection sheet with angraphic and anamnestic data will be developed to correlate the demographic and comorbidity data with the clinical conditions of the patients and with the laboratory findings from the sampling.
Expected results: The primary endpoint will be the correlation between serum estrogen levels, receptor expression and the presence of skin tears. The secondary endopoint will be Correlation between receptor structure and clinical staging of skin tears.
Future prospectives: We believe that our study may open new frontiers in the prevention and in the management of these skin lesions.
详细描述
BACKGROUND Skin tears were firstly defined by Payne RL and Martin ML, and thereafter by more recent studies, as traumatic wounds occurring principally on the upper limbs, as a result of friction alone or shearing and friction forces, which separate the epidermis from the dermis (partial thickness wounds) or which separate both the epidermis and the dermis from underlying structures (full thickness wounds). Skin tears are reported to be a common wound especially on fragile exposed skin, which can be often encountered among older adult, disabled populations and neonates. Skin tears can be found on all areas of the body and are particularly common on the extremities. Skin tears may be also very common in public hospital (PH) inpatients and residents of residential care facilities (RCF) with prevalence up to 41% in these settings.
Skin Tears can cause psychological problems for the patient and represent an economic problem with important effects on both the patient and the community.
The risk factors hitherto hypothesized are many and include: advanced age, spasticity or rigidity, enticement, cognitive decline, long-term drug therapies, inadequate nutritional intake, etc but none of them, individually and independently, was found to be strongly correlated onset of skin tears, in such a way as to be able to effectively associate it with their onset.
Many evidences have correlated, in various physiological or pathological conditions, the role of estrogens with functions and skin aging.
The serum level of estrogens, and in particular estrone and estradiol, and the peripheral expression, in the tissues, of the related estrogenic receptors, estrogen α receptors, estrogen β receptors (ER- α, ER-β) and G protein-coupled estrogen receptor 1 (GPER) may be related to skin tears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Subjects of aged care facilities with skin tears
排除标准
- •Patients who do not give consent;
- •Inability of blood sampling and / or skin biopsy
- •Inclusion Criteria:
- •Subjects of aged care facilities without skin tears
- •Exclusion Criteria:
- •Patients who do not give consent;
- •Inability of blood sampling and / or skin biopsy
结局指标
主要结局
Correlation Between Estrogen and Skin Tears
时间窗: at 1 year
The primary outcome measure will be the correlation between serum estrogen levels and skin receptor expression and skin tears onset.
次要结局
- Correlation between patient's estrogen status and clinical staging of skin tears(at 2 years)
研究者
Prof. Raffaele Serra, MD, Ph.D.
Associate Professor of Vascular Surgery
University of Catanzaro