Estrogens Levels and Receptors Status and Skin Tears

NCT04513405 | Unknown DMC

• 1 other identifier: ER.CZ.2018.04
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Skin Tears; Estrogen Receptors

Outcome Measures

Primary Outcomes (1)

• Correlation Between Estrogen and Skin Tears

  The primary outcome measure will be the correlation between serum estrogen levels and skin receptor expression and skin tears onset.

  at 1 year

Secondary Outcomes (1)

• Correlation between patient's estrogen status and clinical staging of skin tears

  at 2 years

Study Arms (2)

subjects with skin tears (Group A)

OTHER

A sample of peripheral venous blood will be taken to measure the levels of estrone and estradiol. A skin biopsy on the intact skin area near the skin tear will be performed.

Diagnostic Test: Blood sampling; Procedure: Shave Biopsy

subjects without skin tears (Group B)

OTHER

A sample of peripheral venous blood will be taken to measure the levels of estrogen. A skin biopsy (thin layer) on the intact skin area of the arm will be performed in order to evaluate skin estrogen receptors.

Diagnostic Test: Blood sampling; Procedure: Shave Biopsy

Interventions

Blood sampling DIAGNOSTIC_TEST

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.

subjects with skin tears (Group A); subjects without skin tears (Group B)

Shave Biopsy PROCEDURE

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

subjects with skin tears (Group A); subjects without skin tears (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of aged care facilities with skin tears

You may not qualify if:

• Patients who do not give consent;
• Inability of blood sampling and / or skin biopsy
• Group B
• Subjects of aged care facilities without skin tears
• Patients who do not give consent;
• Inability of blood sampling and / or skin biopsy

Sponsors & Collaborators

• University of Catanzaro: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

University La Sapienza of Rome

Roma, 00100, Italy

Location

Related Publications (7)

• Payne RL, Martin ML. The epidemiology and management of skin tears in older adults. Ostomy Wound Manage. 1990 Jan-Feb;26:26-37. No abstract available.

  PMID: 2306325 BACKGROUND

• Payne RL, Martin ML. Defining and classifying skin tears: need for a common language. Ostomy Wound Manage. 1993 Jun;39(5):16-20, 22-4, 26.

  PMID: 8397703 BACKGROUND

• LeBlanc K, Baranoski S, Christensen D, Langemo D, Sammon MA, Edwards K, Holloway S, Gloeckner M, Williams A, Sibbald RG, Regan M. International Skin Tear Advisory Panel: a tool kit to aid in the prevention, assessment, and treatment of skin tears using a Simplified Classification System (c). Adv Skin Wound Care. 2013 Oct;26(10):459-76; quiz 477-8. doi: 10.1097/01.ASW.0000434056.04071.68.

  PMID: 24045566 BACKGROUND

• El Safoury O, Rashid L, Ibrahim M. A study of androgen and estrogen receptors alpha, beta in skin tags. Indian J Dermatol. 2010;55(1):20-4. doi: 10.4103/0019-5154.60345.

  PMID: 20418971 BACKGROUND

• Brincat MP, Baron YM, Galea R. Estrogens and the skin. Climacteric. 2005 Jun;8(2):110-23. doi: 10.1080/13697130500118100.

  PMID: 16096167 BACKGROUND

• Serra R, Gallelli L, Perri P, De Francesco EM, Rigiracciolo DC, Mastroroberto P, Maggiolini M, de Franciscis S. Estrogen Receptors and Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):114-8. doi: 10.1016/j.ejvs.2016.04.020. Epub 2016 May 21.

  PMID: 27220899 BACKGROUND

• Serra R, Ielapi N, Barbetta A, de Franciscis S. Skin tears and risk factors assessment: a systematic review on evidence-based medicine. Int Wound J. 2018 Feb;15(1):38-42. doi: 10.1111/iwj.12815. Epub 2017 Oct 17.

  PMID: 29045078 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Raffaele Serra, M.D., Ph.D.

  University Magna Graecia of Catanzaro

  STUDY CHAIR

• Nicola Ielapi, R.N.

  University La Sapienza of Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Serra, M.D.; Ph.D.

CONTACT

+3909613647380; rserra@unicz.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)