<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/NCT04491656</url>
  </required_header>
  <id_info>
    <org_study_id>EAMC IERB 2020 - 03</org_study_id>
    <nct_id>NCT04491656</nct_id>
  </id_info>
  <brief_title>Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT</brief_title>
  <acronym>WALANT</acronym>
  <official_title>Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT: a Prospective Series of 34 Patients From a Low Resource Tertiary Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>East Avenue Medical Center, Philippines</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>East Avenue Medical Center, Philippines</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>
      Further studies are needed to establish the effects of WALANT in performing most common hand&#xD;
      surgeries, in relation to its clinical outcomes and intraoperative blood loss. Therefore,&#xD;
      this study aims to identify the best interval time to perform elective hand surgeries using&#xD;
      WALANT technique, document clinical outcomes and identify potential complications&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To propose the optimal time delay from the injection to skin incision for most WALANT&#xD;
      surgeries of the hand or wrist by analyzing not only intraoperative blood loss, but also&#xD;
      postoperative pain scores and complication rates&#xD;
&#xD;
      To determine if there is a difference between performing the WALANT technique with a waiting&#xD;
      interval of 7 minutes as compared to 30 minutes prior to incision in relation to blood loss,&#xD;
      pain scores, and complications.&#xD;
&#xD;
      Initiate the use of WALANT technique and its application in practice of Orthopaedic Residents&#xD;
      in East Avenue Medical Center&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VRS Score</measure>
    <time_frame>24 weeks</time_frame>
    <description>Verbal Rating Scale&#xD;
0 for no pain&#xD;
1 for mild pain&#xD;
2 for moderate pain&#xD;
3 for severe pain&#xD;
4 for very severe pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Loss</measure>
    <time_frame>24 weeks</time_frame>
    <description>Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Complications</measure>
    <time_frame>24 weeks</time_frame>
    <description>Complications which may occur during the course of treatment and subsequent follow up of the patients which includes: wound complications, infection, stiffness, pain</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Hand Surgery</condition>
  <condition>Orthopedic Surgery</condition>
  <arm_group>
    <arm_group_label>7 minutes group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 minutes group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WALANT Technique</intervention_name>
    <description>A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet</description>
    <arm_group_label>30 minutes group</arm_group_label>
    <arm_group_label>7 minutes group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. . Signed Consent Form&#xD;
&#xD;
          2. Elective Hand Surgeries&#xD;
&#xD;
          3. Minor Hand Surgeries&#xD;
&#xD;
          4. Adult Male/Female ages 18 and above&#xD;
&#xD;
          5. Multiply injured&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No Consent&#xD;
&#xD;
          2. Multiply injured patient&#xD;
&#xD;
          3. Traumatic Hand Injuries&#xD;
&#xD;
          4. Known allergic reaction to either Epinephrine or Lidocaine.&#xD;
&#xD;
          5. Known heart condition&#xD;
&#xD;
          6. Patients on anticoagulants&#xD;
&#xD;
          7. Patients diagnosed with bleeding disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mamer S. Rosario, MD</last_name>
    <role>Study Chair</role>
    <affiliation>East Avenue Medical Center, Department of Orthopedics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>East Avenue Medical Center; Department of Orthopedics</name>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>East Avenue Medical Center, Philippines</investigator_affiliation>
    <investigator_full_name>Alvin A. Hernandez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient DATA will remain anonymous during the study and to be coded. Outcome measures for all participants will be documented</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>August 2020</ipd_time_frame>
  </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/NCT04491656
org study id: EAMC IERB 2020 - 03
nct id: NCT04491656
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Further studies are needed to establish the effects of WALANT in performing most common hand
      surgeries, in relation to its clinical outcomes and intraoperative blood loss. Therefore,
      this study aims to identify the best interval time to perform elective hand surgeries using
      WALANT technique, document clinical outcomes and identify potential complications
To propose the optimal time delay from the injection to skin incision for most WALANT
      surgeries of the hand or wrist by analyzing not only intraoperative blood loss, but also
      postoperative pain scores and complication rates

      To determine if there is a difference between performing the WALANT technique with a waiting
      interval of 7 minutes as compared to 30 minutes prior to incision in relation to blood loss,
      pain scores, and complications.

      Initiate the use of WALANT technique and its application in practice of Orthopaedic Residents
      in East Avenue Medical Center
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: VRS Score
time frame: 24 weeks
description: Verbal Rating Scale
0 for no pain
1 for mild pain
2 for moderate pain
3 for severe pain
4 for very severe pain
measure: Blood Loss
time frame: 24 weeks
description: Blood loss estimation using Gauze Visual Analogue Scale by Algadiem et.al.
measure: Complications
time frame: 24 weeks
description: Complications which may occur during the course of treatment and subsequent follow up of the patients which includes: wound complications, infection, stiffness, pain
arm group label: 7 minutes group
arm group type: Active Comparator
description: surgeries performed with this group would wait 7 minutes after lidocaine+epinephrine injection prior to skin incision
arm group label: 30 minutes group
arm group type: Active Comparator
description: surgeries performed with this group would wait 30 minutes after lidocaine+epinephrine injection prior to skin incision
intervention type: Other
intervention name: WALANT Technique
description: A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet
arm group label: 30 minutes group
arm group label: 7 minutes group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mamer S. Rosario, MD
role: Study Chair
affiliation: East Avenue Medical Center, Department of Orthopedics
facility: 
country: Philippines
responsible party type: Principal Investigator
investigator affiliation: East Avenue Medical Center, Philippines
investigator full name: Alvin A. Hernandez
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: Patient DATA will remain anonymous during the study and to be coded. Outcome measures for all participants will be documented
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: August 2020