Skin TearESKITENCT04513405
Estrogens Levels and Receptors Status and Skin Tears
A study testing Blood sampling and Shave Biopsy in people with Skin Tear and Estrogen Deficiency, run by University of Catanzaro at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Tear, Estrogen Deficiency
- What is being tested?
- Blood sampling and Shave Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects of aged care facilities with skin tears
- Subjects of aged care facilities without skin tears
Who cannot join
- Patients who do not give consent;
- Inability of blood sampling and / or skin biopsy
- Group B
- Patients who do not give consent;
- Inability of blood sampling and / or skin biopsy
Trial locations and contacts
1 site in 1 country.
Italy1 site
University La Sapienza of Rome
Roma, 00100
Nicola Ielapi, R.N., +393279390726, nicola.ielapi@uniroma1.it
Nicola Ielapi, R.N.
About this study
Official title: Role of Estrogens and Their Receptors in the Development of Skin Tears Evaluated in Residents of Residential Care Facilities.
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.
Read more
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.
Read the detailed description
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.
AIM The aim of the project is to study the correlation between serum estrogen levels and the expression of the related receptors, with the development of skin tears.
METHODOLOGY The project will develop on the analysis of populations of residents coming from ACF belonging to the national territory between a minimum of 10 and a maximum of 30. Each RCF will have to provide a number of subjects between 10 and 40.
The total patient sample will therefore be between a minimum of 100 and a maximum of 1200 subjects.
Therefore, two populations of guests assisted in the RCF will be recruited. A group of subjects affected by skin tears (group A) and a control group of subjects without skin tears (group B).
Patients will be included in both groups via a simple randomization procedure. The informed consent of the patient is required. A group of peripheral venous blood will be made to both groups to measure the levels of estrone and estradiol and a skin biopsy on the intact skin area near the lesion in group A and on a thin layer of healthy skin (Shave Biopsy) in the area of the arm in the control group (group B).
EXPECTED RESULTS Primary Endpoint The primary endpoint will be the correlation between serum estrogen levels, receptor expression and skin tears.
Secondary Endpoint. Correlation between receptorial structure and clinical staging of skin tears.
- Conditions
- Skin Tear, Estrogen Deficiency
- Being tested
- Blood sampling, Shave Biopsy
- Keywords
- Skin Tears, Estrogen Receptors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic 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.
Shave BiopsyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Blood sampling; Procedure: Shave Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 year
Secondary outcomes (1)
Correlation between patient's estrogen status and clinical staging of skin tears
The serum level of estrogens and the peripheral expression of estrogen receptor will be related to the severity of skin tears
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Skin TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Raffaele Serra, M.D., Ph.D., Study chair, University Magna Graecia of CatanzaroNicola Ielapi, R.N., Principal investigator, University La Sapienza of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513405
- Sponsor's protocol ID
- ER.CZ.2018.04
- Acronym
- ESKITE
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2306325Payne 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.
PubMed 8397703LeBlanc 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.
PubMed 24045566El 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.
PubMed 20418971Brincat MP, Baron YM, Galea R. Estrogens and the skin. Climacteric. 2005 Jun;8(2):110-23. doi: 10.1080/13697130500118100.
PubMed 16096167Serra 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.
PubMed 27220899Serra 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.
PubMed 29045078
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Estrogens and Their Receptors in the Development of Skin Tears Evaluated in Residents of Residential Care Facilities.
- ClinicalTrials.gov ID
- NCT04513405
- Acronym / sponsor ID
- ESKITE / ER.CZ.2018.04
- Conditions
- Skin Tear, Estrogen Deficiency
- Keywords
- Skin Tears, Estrogen Receptors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
AIM The aim of the project is to study the correlation between serum estrogen levels and the expression of the related receptors, with the development of skin tears.
METHODOLOGY The project will develop on the analysis of populations of residents coming from ACF belonging to the national territory between a minimum of 10 and a maximum of 30. Each RCF will have to provide a number of subjects between 10 and 40.
The total patient sample will therefore be between a minimum of 100 and a maximum of 1200 subjects.
Therefore, two populations of guests assisted in the RCF will be recruited. A group of subjects affected by skin tears (group A) and a control group of subjects without skin tears (group B).
Patients will be included in both groups via a simple randomization procedure. The informed consent of the patient is required. A group of peripheral venous blood will be made to both groups to measure the levels of estrone and estradiol and a skin biopsy on the intact skin area near the lesion in group A and on a thin layer of healthy skin (Shave Biopsy) in the area of the arm in the control group (group B).
EXPECTED RESULTS Primary Endpoint The primary endpoint will be the correlation between serum estrogen levels, receptor expression and skin tears.
Secondary Endpoint. Correlation between receptorial structure and clinical staging of skin tears.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with skin tears (Group A) | Other | Diagnostic Test: Blood sampling, Procedure: Shave BiopsyA 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. |
| subjects without skin tears (Group B) | Other | Diagnostic Test: Blood sampling, Procedure: Shave BiopsyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects of aged care facilities with skin tears
- Subjects of aged care facilities without skin tears
Key exclusion criteria (5 listed)
- Patients who do not give consent;
- Inability of blood sampling and / or skin biopsy
- Group B
- Patients who do not give consent;
- Inability of blood sampling and / or skin biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplinga 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. | Diagnostic test | subjects with skin tears (Group A), subjects without skin tears (Group B) |
| Shave Biopsyin 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 | Procedure or surgery | subjects with skin tears (Group A), subjects without skin tears (Group B) |
Primary outcome
Correlation Between Estrogen and Skin Tears
Time frame: at 1 year
The primary outcome measure will be the correlation between serum estrogen levels and skin receptor expression and skin tears onset.
1 secondary outcome
Correlation between patient's estrogen status and clinical staging of skin tears
Time frame: at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Background: PubMed 2306325Payne 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.
- Background: PubMed 8397703Payne 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.
- Background: PubMed 24045566LeBlanc 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.
- Background: PubMed 20418971El 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.
- Background: PubMed 16096167Brincat MP, Baron YM, Galea R. Estrogens and the skin. Climacteric. 2005 Jun;8(2):110-23. doi: 10.1080/13697130500118100.
- Background: PubMed 27220899Serra 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.
- Background: PubMed 29045078Serra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Serra, M.D., Ph.D. study chair
University Magna Graecia of Catanzaro
Nicola Ielapi, R.N. principal investigator
University La Sapienza of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Shave Biopsy in people with Skin Tear and Estrogen Deficiency, run by University of Catanzaro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Serra, M.D.; Ph.D. (+3909613647380, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Estrogen and Skin Tears (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04513405, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.