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Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns. (POTER-DIC)

Primary Purpose

Pressure Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tcpO2
Laser Doppler
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pressure Ulcer focused on measuring Pressure, Pressure Ulcer, Skin perfusion, Skin oxygenation

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Phase 1:

  • Inclusion criteria:

    • Healthy volunteers, between 20 to 65 years old, both female and male participants are being studied
    • With no cardiovascular, neurological, digestive, endocrine, renal, gynecological, respiratory, hematologic, infectious, dermatological, autoimmune or diagnosed musculoskeletal disease or functional limitations,
    • With tissue integrity and BMI between 18.5 to 25.9 kg/cm2 without scars in the sacred, back-lumbar, trochanteric, heels, elbows and shoulder blades areas.
  • Exclusion criteria:

    • The usual consumption for any reason of alpha-beta-blocking agents, or alpha-beta agonists,
    • Or directly or indirectly vasodilator-vasoconstrictor action drugs of any kind, •Anticoagulants,
    • Topical or systemic steroids,
    • Presence of pacemakers or implantable defibrillator,
    • Smoking,
    • High consumption of alcohol (>20g/week),
    • Presence of tattoos in the areas of measurement,
    • Lower limb amputation

Phase 2:

  • Inclusion criteria:

    • Patients (both female and male), between 18 to 85 years old, admitted to acute hospitalization, with risk of skin integrity deterioration assessed by Braden scale (punctuation lower than 16)
    • Without pressure ulcers,
    • Who agree to participate in the study.
  • Exclusion criteria:

    • Presence infusion of vasoactive drugs at the time of the study (dopamine, epinephrine, norepinephrine, dobutamine, nitroprusside, nitroglycerin, calcium channel blockers, ACE inhibitors).
    • Regular oral treatment of alpha and beta-blockers
    • And/or agonists or calcium channel blockers, Nitrates, ACE inhibitors, Angiotensin, Renin inhibitors, Diuretics, SSRIs, NSAIDs, will be accepted.
    • Also patients with pacemakers and/or implanted defibrillator,
    • Fever,
    • Anemia with Hb <10g/dl,
    • Hypotension with systolic blood pressure <80 mmHg,
    • Presence of transfusions in the past 4 weeks,
    • Consumption and derivatives of erythropoietin, iron supplements,
    • Oral or parenteral anticoagulants will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Phase I

    Arm Description

    Interventions: Different positions will be applied to subjects to measure preipheral tissue oxygenation, pressure, and changes in microvascular flow. Subjects will be placed up to 4 hours in each of the standard positions for the experiment: supine decubitus (SD) right lateral decubitus (RLD), left lateral decubitus (LLD). SD measurements will be made at 0, 30 and 45 degrees of inclination to bed. RLD and LLD positions will be evaluated with a body inclination of 30 and 90ª. The subjects will lie down on a memory foam mattress for an articulated bed, as are commonly used at home, residential or hospital care. Between the subject and the mattress will be inserted the pressure measuring surface. Measurements in each position will be made during intervals of 0-4 hours in the same position (SD-RLD-LLD) in each of the inclinations of the bed (0º, 30°, 45 °) or body (30º, 90º), respectively.

    Outcomes

    Primary Outcome Measures

    Peripheral tissue oxygenation (transcutaneous oxygen)
    Local noninvasive measurement reflecting the amount of O2 that has diffused from the capillaries, through the epidermis to a Clark-tupe electrode at the measuring site.

    Secondary Outcome Measures

    Microvascular flow in peripheral tissues
    Non invasive measurement through Laser Doppler, using a diode laser emitting continuous divergent radiation. The PeriFlux System 5000 equipped with PF 5010 LDPM Unit(s) is classified in USA as a class 1 laser product according to FDA CFR 1040.10. In Europe, the instrument is classified as a Class 1 laser product according to IEC 60825-1:2007. An optical fiber leads light generated by a laser to the LDPM probe tip, which rests against the tissue. The beam of light will enter the tissue and become scattered. Blood cells moving within the volume illuminated by the beam will cause the light to change frequency. This change in frequency is called a Doppler shift.

    Full Information

    First Posted
    February 25, 2016
    Last Updated
    March 24, 2020
    Sponsor
    University of Malaga
    Collaborators
    Health Service of Andalucia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02736838
    Brief Title
    Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns.
    Acronym
    POTER-DIC
    Official Title
    Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns. A Phase I Trial (POTER-DIC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaga
    Collaborators
    Health Service of Andalucia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objectives: 1. To analyze the changes in peripheral tissue oxygenation in tissues subjected to different pressure regimes in healthy humans. 2. To analyze changes in microvascular flow in peripheral tissues subjected to different pressure regimes in healthy humans. 3. To determine thresholds of tissue perfusion flow and transcutaneous oxygen depending on exposure levels and angling pressure in healthy volunteers. 4. To evaluate the distribution of tissue perfusion flow and transcutaneous oxygenation in real clinical situations in residential care and acute hospital care in patients at risk for impaired skin integrity. Methodology: Experimental non-controlled, non-randomized study in two phases: preclinical and clinical. The first phase, will be conducted in healthy volunteers and the second, in patients at risk for impaired skin integrity. Vascular flow, tissue oxygenation and local temperature in areas at risk of pressure ulcers by Doppler laser will be evaluated in subjects lying on a capacitive surface to measure pressure with 10,249 points of measurement, which will be subject to different body systems to generate different levels of pressure and monitor changes in tissue perfusion and oxygenation up to 4 hours, to know the implications for repositioning interventions in patients at risk.
    Detailed Description
    Sample: the preclinical phase will be conducted in 20 healthy volunteers enrolled in the Faculty of Health Sciences of the University of Malaga. Clinical phase will take place in 12 subjects admitted to acute hospitalization in 'Costa del Sol' Health Agency and 12 subjects admitted to nursing homes in the District of Primary Knowing this information will identify different thresholds start in peripheral microcirculation disorders associated with various systems of body position and consequent pressure levels. This particular seems a reasonable need from baseline parameters allow to further explore specific situations of tissue injury and isolate direct and indirect causal factors. It is also necessary to conduct the study in subjects from different environments (home, hospital) to determine under real clinical practice how these parameters behave and how it can affect common procedures performed in clinical practice, such as repositioning or using pressure surfaces. This sample of 24 subjects was calculated taking into account a change in the capillary flow of 30% between baseline and the first hour of exposure to pressure, according to data of Kallman et al. (15) with an 80% output and statistical confidence level of 95%. In total, each subject will provide a total of 28 hours of measurement. Phase 1: Inclusion criteria:Healthy volunteers, between 20 and 65 years old, with no cardiovascular, neurological, digestive, endocrine, renal, gynecological, respiratory, hematologic, infectious, dermatological, autoimmune or diagnosed musculoskeletal disease or functional limitations, with tissue integrity and BMI between 18.5 to 25.9 kg/cm2 without scars in the sacred, back-lumbar, trochanteric, heels, elbows and shoulder blades areas. Exclusion criteria: The usual consumption for any reason of alpha-beta-blocking agents, or alpha-beta agonists, or directly or indirectly vasodilator-vasoconstrictor action drugs of any kind, anticoagulants, topical or systemic steroids, presence of pacemakers or implantable defibrillator, smoking, high consumption of alcohol (>20g/week), presence of tattoos in the areas of measurement, and lower limb amputation Phase 2: Inclusion criteria: Patients admitted to acute hospitalization, with risk of skin integrity deterioration assessed by Braden scale (punctuation lower than 16) without pressure ulcers, who agree to participate in the study. Exclusion criteria: presence infusion of vasoactive drugs at the time of the study (dopamine, epinephrine, norepinephrine, dobutamine, nitroprusside, nitroglycerin, calcium channel blockers, ACE inhibitors). Regular oral treatment of alpha and beta-blockers and/or agonists or calcium channel blockers, nitrates, ACE inhibitors, angiotensin, renin inhibitors, diuretics, SSRIs, NSAIDs, will be accepted. Also patients with pacemakers and/or implanted defibrillator, fever, anemia with Hb <10g/dl, hypotension with systolic blood pressure <80 mmHg, presence of transfusions in the past 4 weeks, consumption and derivatives of erythropoietin, iron supplements, oral or parenteral anticoagulants will be excluded. Interventions: Different positions will be applied to subjects in order to measure preipheral tissue oxygenation, pressure, and changes in microvascular flow. The subject will be placed in each of the standard positions for the experiment: supine decubitus (SD) right lateral decubitus (RLD), left lateral decubitus (LLD). SD measurements will be made at 0, 30 and 45 degrees of inclination to bed. RLD and LLD positions will be evaluated with a body inclination of 30 and 90 degrees, aided by pillows, as is done in routine clinical practice. The subjects will lie down on a memory foam mattress for an articulated bed, as are commonly used at home, residential or hospital care. Between the subject and the mattress will be inserted the pressure measuring surface. Measurements in each position will be made during intervals of 0-4 hours in the same position (SD-RLD-LLD) in each of the inclinations of the bed (0º, 30°, 45 °) or body (30º, 90º), respectively. In case of patients, if the institutional protocol sets repositioning with a frequency of less than 4 hours, measurements will be made to the maximum that is set in each protocol. Otherwise, the maximum time for each position will be 4 hours. Measuring instruments: Pressure measurements will be made with the XSENSOR PX100: 64.160.02 (31.2 x 203.2 cm) pressure sensor, with 12.7 mm of space resolution of, which has 10,240 measuring points. The pressure sensor is composed with two perpendicularly oriented networks of parallel conductive strips, which are separated by a fine compressible elastomer. The intersection of two strips forms a capacitive node, determined by the surface of intersection of the two strips, and the distance separation between them, and with the elastomer. When pressure is applied to the node, the elastomer is compressed, the bands approach and capacity increases. This change in capacitance is correlated with pressure through a calibration process. The pressure range that is able to detect varies between 0.2 to 3.87 psi. Tissue perfusion, oxygenation and temperature of the assessed area will be made with the system Periflux 5000, composed of 2 units of Laser Doppler Flowmetry (LDF): PeriFlux 5001, which includes the laser source; and PeriFlux 5002, which provides temperature and tissue oxygenation measurements. The information of both instruments will be collected and integrated into a software that allows the simultaneous measurement of all signals. Tissue oxygenation will be measured by transcutaneous oximetry (TcpO2), a noninvasive procedure that reflects the amount of oxygen diffuses into the capillaries through the epidermis. This process depends on the state of respiratory oxygenation, the oxygen carrying capacity of blood and the overall circulatory condition. Any deterioration in any of these three members, immediately affect the skin tissue perfusion, which allows to evaluate how these factors affect the PU risk. It is measured by an electrode that heats the underlying tissue to create a local hyperemia that intensifies blood perfusion and, consecuently, oxygen pressure increases. The heat dissolves the lipid structure of the keratinized layers of the epidermis, allowing the skin permeability to gas diffusion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure Ulcer
    Keywords
    Pressure, Pressure Ulcer, Skin perfusion, Skin oxygenation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase I
    Arm Type
    Experimental
    Arm Description
    Interventions: Different positions will be applied to subjects to measure preipheral tissue oxygenation, pressure, and changes in microvascular flow. Subjects will be placed up to 4 hours in each of the standard positions for the experiment: supine decubitus (SD) right lateral decubitus (RLD), left lateral decubitus (LLD). SD measurements will be made at 0, 30 and 45 degrees of inclination to bed. RLD and LLD positions will be evaluated with a body inclination of 30 and 90ª. The subjects will lie down on a memory foam mattress for an articulated bed, as are commonly used at home, residential or hospital care. Between the subject and the mattress will be inserted the pressure measuring surface. Measurements in each position will be made during intervals of 0-4 hours in the same position (SD-RLD-LLD) in each of the inclinations of the bed (0º, 30°, 45 °) or body (30º, 90º), respectively.
    Intervention Type
    Device
    Intervention Name(s)
    tcpO2
    Intervention Description
    Skin oxygenation will be measured by tcpO2, and microvascular flow with Laser Doppler. Measurements will be made inserting probes in sacrum, trochanters, elbows and heels, before and after the end of each decubitus lying period, and in every position and angle. Pressure: Continuous pressure measurements will be made in sacrum, trochanters, elbows and heels. Measures will be carried out at sessions separated at intervals of 7 days, with 0 to 4 hours of experimental exposure to pressure, different bed angles (0º, 30º, 45º), and lateral decubitus tilts (30, 90). Bioimpedance will be performed at baseline early in the morning, fasting and after emptying the bladder. Subjects will be lying without clothes, in a supine position on the bed, with a distance of at least 25 cm between thighs. The measurement will be made in single frequency mode (50 kHz , 400 μARMS) with a tetrapolar electrode arrangement.
    Intervention Type
    Device
    Intervention Name(s)
    Laser Doppler
    Primary Outcome Measure Information:
    Title
    Peripheral tissue oxygenation (transcutaneous oxygen)
    Description
    Local noninvasive measurement reflecting the amount of O2 that has diffused from the capillaries, through the epidermis to a Clark-tupe electrode at the measuring site.
    Time Frame
    Change from Baseline in each four hour session of the eleven measurement periods along days 1-2-3-4-5. From September 2016 to May 2017
    Secondary Outcome Measure Information:
    Title
    Microvascular flow in peripheral tissues
    Description
    Non invasive measurement through Laser Doppler, using a diode laser emitting continuous divergent radiation. The PeriFlux System 5000 equipped with PF 5010 LDPM Unit(s) is classified in USA as a class 1 laser product according to FDA CFR 1040.10. In Europe, the instrument is classified as a Class 1 laser product according to IEC 60825-1:2007. An optical fiber leads light generated by a laser to the LDPM probe tip, which rests against the tissue. The beam of light will enter the tissue and become scattered. Blood cells moving within the volume illuminated by the beam will cause the light to change frequency. This change in frequency is called a Doppler shift.
    Time Frame
    Change from Baseline in each four hour session of the eleven measurement periods along days 1-2-3-4-5. From September 2016 to May 2017

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Phase 1: Inclusion criteria: Healthy volunteers, between 20 to 65 years old, both female and male participants are being studied With no cardiovascular, neurological, digestive, endocrine, renal, gynecological, respiratory, hematologic, infectious, dermatological, autoimmune or diagnosed musculoskeletal disease or functional limitations, With tissue integrity and BMI between 18.5 to 25.9 kg/cm2 without scars in the sacred, back-lumbar, trochanteric, heels, elbows and shoulder blades areas. Exclusion criteria: The usual consumption for any reason of alpha-beta-blocking agents, or alpha-beta agonists, Or directly or indirectly vasodilator-vasoconstrictor action drugs of any kind, •Anticoagulants, Topical or systemic steroids, Presence of pacemakers or implantable defibrillator, Smoking, High consumption of alcohol (>20g/week), Presence of tattoos in the areas of measurement, Lower limb amputation Phase 2: Inclusion criteria: Patients (both female and male), between 18 to 85 years old, admitted to acute hospitalization, with risk of skin integrity deterioration assessed by Braden scale (punctuation lower than 16) Without pressure ulcers, Who agree to participate in the study. Exclusion criteria: Presence infusion of vasoactive drugs at the time of the study (dopamine, epinephrine, norepinephrine, dobutamine, nitroprusside, nitroglycerin, calcium channel blockers, ACE inhibitors). Regular oral treatment of alpha and beta-blockers And/or agonists or calcium channel blockers, Nitrates, ACE inhibitors, Angiotensin, Renin inhibitors, Diuretics, SSRIs, NSAIDs, will be accepted. Also patients with pacemakers and/or implanted defibrillator, Fever, Anemia with Hb <10g/dl, Hypotension with systolic blood pressure <80 mmHg, Presence of transfusions in the past 4 weeks, Consumption and derivatives of erythropoietin, iron supplements, Oral or parenteral anticoagulants will be excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Silvia García-Mayor, PhD
    Organizational Affiliation
    Faculty of Health Sciences, University of Málaga, Spain
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23375662
    Citation
    Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, Farrin A, Brown J, Schoonhoven L, Nixon J. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013 Jul;50(7):974-1003. doi: 10.1016/j.ijnurstu.2012.11.019. Epub 2013 Feb 1.
    Results Reference
    background
    PubMed Identifier
    24684197
    Citation
    Coleman S, Nixon J, Keen J, Wilson L, McGinnis E, Dealey C, Stubbs N, Farrin A, Dowding D, Schols JM, Cuddigan J, Berlowitz D, Jude E, Vowden P, Schoonhoven L, Bader DL, Gefen A, Oomens CW, Nelson EA. A new pressure ulcer conceptual framework. J Adv Nurs. 2014 Oct;70(10):2222-34. doi: 10.1111/jan.12405. Epub 2014 Mar 31.
    Results Reference
    background
    PubMed Identifier
    17255369
    Citation
    Stekelenburg A, Strijkers GJ, Parusel H, Bader DL, Nicolay K, Oomens CW. Role of ischemia and deformation in the onset of compression-induced deep tissue injury: MRI-based studies in a rat model. J Appl Physiol (1985). 2007 May;102(5):2002-11. doi: 10.1152/japplphysiol.01115.2006. Epub 2007 Jan 25.
    Results Reference
    background
    PubMed Identifier
    25561248
    Citation
    Moore ZE, Cowman S. Repositioning for treating pressure ulcers. Cochrane Database Syst Rev. 2015 Jan 5;1(1):CD006898. doi: 10.1002/14651858.CD006898.pub4.
    Results Reference
    background
    PubMed Identifier
    24700291
    Citation
    Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev. 2014 Apr 3;2014(4):CD009958. doi: 10.1002/14651858.CD009958.pub2.
    Results Reference
    background
    PubMed Identifier
    23817702
    Citation
    Chou R, Dana T, Bougatsos C, Blazina I, Starmer AJ, Reitel K, Buckley DI. Pressure ulcer risk assessment and prevention: a systematic comparative effectiveness review. Ann Intern Med. 2013 Jul 2;159(1):28-38. doi: 10.7326/0003-4819-159-1-201307020-00006.
    Results Reference
    background
    PubMed Identifier
    21135794
    Citation
    Nakagami G, Sanada H, Iizaka S, Kadono T, Higashino T, Koyanagi H, Haga N. Predicting delayed pressure ulcer healing using thermography: a prospective cohort study. J Wound Care. 2010 Nov;19(11):465-6, 468, 470 passim. doi: 10.12968/jowc.2010.19.11.79695.
    Results Reference
    background
    PubMed Identifier
    22879313
    Citation
    Farid KJ, Winkelman C, Rizkala A, Jones K. Using temperature of pressure-related intact discolored areas of skin to detect deep tissue injury: an observational, retrospective, correlational study. Ostomy Wound Manage. 2012 Aug;58(8):20-31.
    Results Reference
    background
    PubMed Identifier
    7605187
    Citation
    Kokate JY, Leland KJ, Held AM, Hansen GL, Kveen GL, Johnson BA, Wilke MS, Sparrow EM, Iaizzo PA. Temperature-modulated pressure ulcers: a porcine model. Arch Phys Med Rehabil. 1995 Jul;76(7):666-73. doi: 10.1016/s0003-9993(95)80637-7.
    Results Reference
    background
    PubMed Identifier
    24585161
    Citation
    Behrendt R, Ghaznavi AM, Mahan M, Craft S, Siddiqui A. Continuous bedside pressure mapping and rates of hospital-associated pressure ulcers in a medical intensive care unit. Am J Crit Care. 2014 Mar;23(2):127-33. doi: 10.4037/ajcc2014192.
    Results Reference
    background
    PubMed Identifier
    25779688
    Citation
    Swisher SL, Lin MC, Liao A, Leeflang EJ, Khan Y, Pavinatto FJ, Mann K, Naujokas A, Young D, Roy S, Harrison MR, Arias AC, Subramanian V, Maharbiz MM. Impedance sensing device enables early detection of pressure ulcers in vivo. Nat Commun. 2015 Mar 17;6:6575. doi: 10.1038/ncomms7575.
    Results Reference
    background
    PubMed Identifier
    17690759
    Citation
    Sarnik S, Hofirek I, Sochor O. Laser Doppler fluxmetry. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2007 Jun;151(1):143-6. doi: 10.5507/bp.2007.028.
    Results Reference
    background
    PubMed Identifier
    25037449
    Citation
    Kallman U, Engstrom M, Bergstrand S, Ek AC, Fredrikson M, Lindberg LG, Lindgren M. The effects of different lying positions on interface pressure, skin temperature, and tissue blood flow in nursing home residents. Biol Res Nurs. 2015 Mar;17(2):142-51. doi: 10.1177/1099800414540515. Epub 2014 Jul 18.
    Results Reference
    background
    PubMed Identifier
    31651050
    Citation
    Gomez-Gonzalez AJ, Morilla-Herrera JC, Lupianez-Perez I, Morales-Asencio JM, Garcia-Mayor S, Leon-Campos A, Marfil-Gomez R, Aranda-Gallardo M, Moya-Suarez AB, Kaknani-Uttumchandani S. Perfusion, tissue oxygenation and peripheral temperature in the skin of heels of healthy participants exposed to pressure: a quasi-experimental study. J Adv Nurs. 2020 Feb;76(2):654-663. doi: 10.1111/jan.14250. Epub 2019 Nov 20.
    Results Reference
    derived
    PubMed Identifier
    28792613
    Citation
    Garcia-Mayor S, Morilla-Herrera JC, Lupianez-Perez I, Kaknani Uttumchandani S, Leon Campos A, Aranda-Gallardo M, Moya-Suarez AB, Morales-Asencio JM. Peripheral perfusion and oxygenation in areas of risk of skin integrity impairment exposed to pressure patterns. A phase I trial (POTER Study). J Adv Nurs. 2018 Feb;74(2):465-471. doi: 10.1111/jan.13414. Epub 2017 Sep 15.
    Results Reference
    derived

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    Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns.

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