<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03039153</url>
  </required_header>
  <id_info>
    <org_study_id>0000669</org_study_id>
    <nct_id>NCT03039153</nct_id>
  </id_info>
  <brief_title>Pressure Ulcers in Knee Replacement Surgery</brief_title>
  <acronym>peripress</acronym>
  <official_title>The Peripheral Nerve Blocks Analgesia in Patients Undergoing Knee Replacement Surgery is a Risk Factor for the Development of Pressure Sores at the Heel? Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Rizzoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Ortopedico Rizzoli</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      From the point of view of nursing to know exactly the different risk factors for the onset of&#xD;
      pressure ulcers is very important as it allows to accurately orient preventive care&#xD;
      interventions.&#xD;
&#xD;
      All the variable that could influence the development of pressure ulcer in patients&#xD;
      undergoing knee replacement surgery are identified and collected: age, sex, body max index,&#xD;
      risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology&#xD;
      of the devices used, such as air mattresses with alternating or static pressure, heel drains,&#xD;
      frequency of mobilization carried out by both the patient care), management of eventual&#xD;
      incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia,&#xD;
      length of stay, the ASA physical status classification system (ASA score), comorbidity,&#xD;
      cancer, use of devices for controlling the position of the operated limb (foam valve), the&#xD;
      number of physical therapy sessions actually carried out.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">December 13, 2017</completion_date>
  <primary_completion_date type="Actual">December 13, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Heel Pressure Sores</measure>
    <time_frame>every day until discharge (expected average of 6 days).</time_frame>
    <description>Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heel Pressure Sores of grade ≥2</measure>
    <time_frame>every day until discharge (expected average of 6 days).</time_frame>
    <description>Numbers of Participants With Heel Pressure Sores of grade ≥2 Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure Sores in any other site</measure>
    <time_frame>every day until discharge (expected average of 6 days).</time_frame>
    <description>Numbers of Participants With Pressure Sores in any other site Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>up to the first 3 days post intervention</time_frame>
    <description>Pain Score on the &quot;Numeric Rating Scale (NRS)&quot;. The NRS scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain</description>
  </secondary_outcome>
  <enrollment type="Actual">565</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Pressure Ulcer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing knee replacement surgery following chronic joint disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary knee joint replacement&#xD;
&#xD;
          -  Secondary knee joint replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer patients&#xD;
&#xD;
          -  Adult or Senior with pressure ulcer at the heel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gianfranco Ferrarelli, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Ortopedico Rizzoli</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03039153
org study id: 0000669
nct id: NCT03039153
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
From the point of view of nursing to know exactly the different risk factors for the onset of
      pressure ulcers is very important as it allows to accurately orient preventive care
      interventions.

      All the variable that could influence the development of pressure ulcer in patients
      undergoing knee replacement surgery are identified and collected: age, sex, body max index,
      risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology
      of the devices used, such as air mattresses with alternating or static pressure, heel drains,
      frequency of mobilization carried out by both the patient care), management of eventual
      incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia,
      length of stay, the ASA physical status classification system (ASA score), comorbidity,
      cancer, use of devices for controlling the position of the operated limb (foam valve), the
      number of physical therapy sessions actually carried out.
observational model: Cohort
time perspective: Retrospective
measure: Heel Pressure Sores
time frame: every day until discharge (expected average of 6 days).
description: Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.
measure: Heel Pressure Sores of grade ≥2
time frame: every day until discharge (expected average of 6 days).
description: Numbers of Participants With Heel Pressure Sores of grade ≥2 Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.
measure: Pressure Sores in any other site
time frame: every day until discharge (expected average of 6 days).
description: Numbers of Participants With Pressure Sores in any other site Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.
measure: Pain
time frame: up to the first 3 days post intervention
description: Pain Score on the "Numeric Rating Scale (NRS)". The NRS scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Gianfranco Ferrarelli, RN
role: Principal Investigator
affiliation: Istituto Ortopedico Rizzoli
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Pressure Ulcer
sharing ipd: No