xml: <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/NCT06015139</url>
    </required_header>
    <id_info>
      <org_study_id>Yu, Hsing-sheng</org_study_id>
      <nct_id>NCT06015139</nct_id>
    </id_info>
    <brief_title>Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery</brief_title>
    <official_title>Comparison of the Effectiveness of Positioning Device Cotton Roll-coated Viscoelastic Polymer Pads Versus Viscoelastic Polymer Pads for Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Central Taiwan University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Central Taiwan University of Science and Technology</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>
        Background：Pressure injuries (PI) are one of the common comorbidities in surgery, meaning PI&#xD;
        that occurs immediately after surgery or within hours to 3 days after surgery. The incidence&#xD;
        of PI in spine surgery is about 5% ~ 66%.&#xD;
  &#xD;
        Purpose：Comparison of the difference in pressure injury rates positioning device cotton&#xD;
        roll-coated viscoelastic polymer pads versus viscoelastic polymer pads for pressure injuries&#xD;
        undergoing lumbar spine surgery Methods：This experimental study used a split-body design with&#xD;
        random assignment to compare the pressure-reducing effects of different materials on a&#xD;
        patient's body contact points with a positioning device. The experimental group used a&#xD;
        Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads, while the&#xD;
        control group used a Relton-Hall prone frame with a viscoelastic polymer pads.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study focuses on patients undergoing lumbar surgery in a hospital in a certain area of&#xD;
        northern Taiwan, with an intended recruitment of 50 participants randomized into experimental&#xD;
        and control groups. The study will use the Pressure Injury grading system developed by the&#xD;
        National Pressure Injury Advisory Panel to assess the severity of pressure injuries at&#xD;
        pre-operation, immediate post-operation, 30 minutes post-operation, 24 hours post-operation,&#xD;
        and 48 hours post-operation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery</measure>
      <time_frame>immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation</time_frame>
      <description>The four parts of the patient's body in contact with the positioning device (left chest, left iliac crest and right chest, right iliac crest) were randomly divided into an experimental group or a control group, and the decompression effect of different materials on positioning the device on the patient's body was compared; the experiment The group used the positioning device Relton-Hall prone frame cotton roll to cover the 3 cm fat pad, and the control group used the Relton-Hall prone frame fat pad.&#xD;
  The severity of PI in the experimental and control groups was assessed and measured according to the pressure injury grading developed by the National Pressure Injury Advisory Committee. After surgery, return the patient from the prone position to the supine position. Immediately after the operation, 24 hours and 48 hours after the operation, observe the occurrence of pressure injury in the experimental group and the control group.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Pressure Injury</condition>
    <arm_group>
      <arm_group_label>viscoelastic polymer pads</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cotton roll-coated viscoelastic polymer pads</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>cotton roll-coated viscoelastic polymer pads</intervention_name>
      <description>relton-hall frame cotton roll-coated viscoelastic polymer pads</description>
      <arm_group_label>cotton roll-coated viscoelastic polymer pads</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>viscoelastic polymer pads</intervention_name>
      <description>relton-hall frame viscoelastic polymer pads</description>
      <arm_group_label>viscoelastic polymer pads</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients receiving lumbar nerve decompression combined with internal fixation and bone&#xD;
               fusion.&#xD;
  &#xD;
            2. Use the positioning device Relton-Hall rack in prone position.&#xD;
  &#xD;
            3. The operation time is more than 2.5 hours.&#xD;
  &#xD;
            4. The surgical anesthesia is general anesthesia.&#xD;
  &#xD;
            5. Routine surgery registered on the surgery schedule.&#xD;
  &#xD;
            6. Before the operation, the skin was intact and there was no pressure injury.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Emergency lumbar surgery patients.&#xD;
  &#xD;
            2. Under the age of 18.&#xD;
  &#xD;
            3. The operation time is less than 2.5 hours.&#xD;
  &#xD;
            4. Preoperative skin incompleteness (obviously there is chest and iliac crest crush&#xD;
               phenomenon).&#xD;
  &#xD;
            5. Percutaneous minimally invasive disc herniation decompression (percutaneous endoscopic&#xD;
               lumbar disc, PELD).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chin-Ying Dai</last_name>
      <role>Study Director</role>
      <affiliation>advising professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hsing-sheng Yu</last_name>
      <phone>+886913966976</phone>
      <email>youss35@yahoo.com.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dachien Hospital</name>
        <address>
          <city>Miaoli</city>
          <state>Gongjing Rd</state>
          <zip>No. 36</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hsing Sheng Yu, nurse</last_name>
        <phone>886913966976</phone>
        <email>youss35@yahoo.com.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Central Taiwan University of Science and Technology</investigator_affiliation>
      <investigator_full_name>Yu, Hsing-Sheng</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>pressure injury</keyword>
    <keyword>positioning devices</keyword>
    <keyword>prophylactic</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Crush Injuries</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol: Proposal</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 7, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT06015139/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Study Protocol and Informed Consent Form: Subject Consent</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 6, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT06015139/Prot_ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015139
  org study id: Yu, Hsing-sheng
  nct id: NCT06015139
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background：Pressure injuries (PI) are one of the common comorbidities in surgery, meaning PI
        that occurs immediately after surgery or within hours to 3 days after surgery. The incidence
        of PI in spine surgery is about 5% ~ 66%.
  
        Purpose：Comparison of the difference in pressure injury rates positioning device cotton
        roll-coated viscoelastic polymer pads versus viscoelastic polymer pads for pressure injuries
        undergoing lumbar spine surgery Methods：This experimental study used a split-body design with
        random assignment to compare the pressure-reducing effects of different materials on a
        patient's body contact points with a positioning device. The experimental group used a
        Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads, while the
        control group used a Relton-Hall prone frame with a viscoelastic polymer pads.
  The study focuses on patients undergoing lumbar surgery in a hospital in a certain area of
        northern Taiwan, with an intended recruitment of 50 participants randomized into experimental
        and control groups. The study will use the Pressure Injury grading system developed by the
        National Pressure Injury Advisory Panel to assess the severity of pressure injuries at
        pre-operation, immediate post-operation, 30 minutes post-operation, 24 hours post-operation,
        and 48 hours post-operation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery
  time frame: immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation
  description: The four parts of the patient's body in contact with the positioning device (left chest, left iliac crest and right chest, right iliac crest) were randomly divided into an experimental group or a control group, and the decompression effect of different materials on positioning the device on the patient's body was compared; the experiment The group used the positioning device Relton-Hall prone frame cotton roll to cover the 3 cm fat pad, and the control group used the Relton-Hall prone frame fat pad.
  The severity of PI in the experimental and control groups was assessed and measured according to the pressure injury grading developed by the National Pressure Injury Advisory Committee. After surgery, return the patient from the prone position to the supine position. Immediately after the operation, 24 hours and 48 hours after the operation, observe the occurrence of pressure injury in the experimental group and the control group.
  arm group label: viscoelastic polymer pads
  arm group type: Active Comparator
  description: while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads
  arm group label: cotton roll-coated viscoelastic polymer pads
  arm group type: Experimental
  description: The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads
  intervention type: Device
  intervention name: cotton roll-coated viscoelastic polymer pads
  description: relton-hall frame cotton roll-coated viscoelastic polymer pads
  arm group label: cotton roll-coated viscoelastic polymer pads
  intervention type: Device
  intervention name: viscoelastic polymer pads
  description: relton-hall frame viscoelastic polymer pads
  arm group label: viscoelastic polymer pads
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chin-Ying Dai
  role: Study Director
  affiliation: advising professor
  last name: Hsing-sheng Yu
  phone: +886913966976
  email: youss35@yahoo.com.tw
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Central Taiwan University of Science and Technology
  investigator full name: Yu, Hsing-Sheng
  investigator title: Principal Investigator
  mesh term: Wounds and Injuries
  mesh term: Crush Injuries
  provided document: 
  provided document: 