Estrogens Levels and Receptors Status and Skin Tears

Summary

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.

Conditions

• Skin Tear
• Estrogen Deficiency

Interventions

DIAGNOSTIC_TEST

Blood sampling

a peripheral venous blood sample will be analyzed to measure the levels of estrone and estradiol. The sample of the blood sample will be deposited in the red cap tube with a polymeric gel.

PROCEDURE

Shave Biopsy

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) correlates with the functional status of these receptors

Sponsors & Collaborators

• University of Roma La Sapienza

  collaborator OTHER

• University of Catanzaro

  lead OTHER

Principal Investigators

• Raffaele Serra, M.D., Ph.D. · University Magna Graecia of Catanzaro

• Nicola Ielapi, R.N. · University La Sapienza of Rome

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2021-09-01

Completion

2022-09-01

Countries

• Italy

Study Locations