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/NCT06014411</url>
    </required_header>
    <id_info>
      <org_study_id>2023-1723</org_study_id>
      <secondary_id>21-04023565</secondary_id>
      <nct_id>NCT06014411</nct_id>
    </id_info>
    <brief_title>Early Versus Delayed Bathing of Orthopaedic Surgical Wounds</brief_title>
    <acronym>EVDB</acronym>
    <official_title>Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital for Special Surgery, New York</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>New York Presbyterian Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hospital for Special Surgery, New York</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>
        This is a single center randomized control trial assessing the effect of early versus delayed&#xD;
        bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of&#xD;
        fractures. Patients will be recruited by screening all patients undergoing surgical treatment&#xD;
        for fractures at our institution. Patients who provide written consent will be randomized to&#xD;
        one of two treatment arms after confirming eligibility criteria. Group A will be advised to&#xD;
        begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B&#xD;
        will be advised to follow traditional delayed bathing with covered wounds.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a single center, non-inferiority, parallel group, randomized control trial&#xD;
        assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in&#xD;
        patients undergoing surgical treatment of fractures. Patients will be recruited by screening&#xD;
        all patients undergoing surgical treatment for fractures at our institution. Patients who&#xD;
        provide written consent will be randomized to one of two treatment arms after confirming&#xD;
        eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged&#xD;
        showering) with uncovered surgical wounds. Group B will be advised to follow traditional&#xD;
        delayed bathing with covered wounds.&#xD;
  &#xD;
        Patients will have follow-up with data collection at two, six and 12 weeks post-operatively.&#xD;
        The primary outcome measure will be patient satisfaction as measured by a Likert Scale. The&#xD;
        Likert Scale as utilized will be a patient reported outcome measure consisting of one&#xD;
        question allowing the subject to express their attitude towards a particular subject: &quot;How&#xD;
        satisfied are you with your surgical treatment&quot; with possible answers consisting of: &quot;very&#xD;
        satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;neutral&quot;, &quot;somewhat unsatisfied&quot;, and &quot;very unsatisfied&quot;.&#xD;
        The secondary outcome measures will be development of an infection (subcategorized as either&#xD;
        superficial or deep) and development of peri-incisional inflammation (eg. adhesive rash).&#xD;
  &#xD;
        Primary Objective: The primary objective of the study is to compare patient satisfaction as&#xD;
        measured using a Likert Scale associated with early and delayed surgical site bathing.&#xD;
  &#xD;
        Secondary Objectives: The secondary objective is to compare the infection rate of orthopaedic&#xD;
        surgical wounds between early and delayed bathing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 25, 2024</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>Supportive Care</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient satisfaction associated with early and delayed surgical site bathing</measure>
      <time_frame>Weeks 2, 6 and 12 post surgery</time_frame>
      <description>The primary endpoint of the study will be a statistically significant difference in patient satisfaction as measured using a Likert Scale between the two groups. Scale will be on scale 0-10. A score of 10 will be &quot;Very Satisfied&quot; and a score of 0 will be &quot;Very Dissatisfied.&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Infection rate of orthopaedic surgical wounds between early and delayed bathing</measure>
      <time_frame>Weeks 12 post surgery</time_frame>
      <description>The secondary endpoint in this study will be a statistically significant or clinically important difference in infection rate of orthopaedic surgical wounds between the early and delayed bathing groups</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Surgical Wound</condition>
    <condition>Post Operative Wound Infection</condition>
    <arm_group>
      <arm_group_label>Delayed Bathing</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Early Bathing</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Time to bathing (delayed)</intervention_name>
      <description>Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).</description>
      <arm_group_label>Delayed Bathing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Time to bathing (early)</intervention_name>
      <description>Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.</description>
      <arm_group_label>Early Bathing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients over 18 years of age&#xD;
  &#xD;
            -  Patient who are not pregnant&#xD;
  &#xD;
            -  Isolated acute fractures of the upper or lower extremities (humerus, radius, ulna,&#xD;
               femur, tibia, or fibula)&#xD;
  &#xD;
            -  Diagnosis of a fracture meeting indication for operative intervention&#xD;
  &#xD;
            -  Any fracture not requiring a splint for post-operative management&#xD;
  &#xD;
            -  Non-complicated wounds (non-traumatic wounds, closed injuries, fractures not requiring&#xD;
               external fixation, and acute fracture surgery)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Fractures associated with presumed infection&#xD;
  &#xD;
            -  Patients with multiple fractures&#xD;
  &#xD;
            -  Fractures in patients with underlying associated immune compromise&#xD;
  &#xD;
            -  Fractures in patients with underlying peripheral vascular disease&#xD;
  &#xD;
            -  Use of VAC&#xD;
  &#xD;
            -  Surgery performed through previous surgical wound&#xD;
  &#xD;
            -  Patient homeless&#xD;
  &#xD;
            -  Fractures in patients with underlying diabetes mellitus&#xD;
  &#xD;
            -  Complicated wounds (traumatic wounds, need for post-op wound care, open injuries, need&#xD;
               for external fixation)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>William M Ricci, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital for Special Surgery, New York</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>William M Ricci, MD</last_name>
      <phone>212-606-1026</phone>
      <email>ricciw@hss.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Craig E Klinger, BA</last_name>
      <phone>212-606-1641</phone>
      <email>klingerc@hss.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital for Special Surgery, New York</investigator_affiliation>
      <investigator_full_name>William Ricci</investigator_full_name>
      <investigator_title>Chief Orthopaedic Trauma Service</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wound Infection</mesh_term>
      <mesh_term>Surgical Wound Infection</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Surgical Wound</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06014411
  org study id: 2023-1723
  secondary id: 21-04023565
  nct id: NCT06014411
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single center randomized control trial assessing the effect of early versus delayed
        bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of
        fractures. Patients will be recruited by screening all patients undergoing surgical treatment
        for fractures at our institution. Patients who provide written consent will be randomized to
        one of two treatment arms after confirming eligibility criteria. Group A will be advised to
        begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B
        will be advised to follow traditional delayed bathing with covered wounds.
  The study is a single center, non-inferiority, parallel group, randomized control trial
        assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in
        patients undergoing surgical treatment of fractures. Patients will be recruited by screening
        all patients undergoing surgical treatment for fractures at our institution. Patients who
        provide written consent will be randomized to one of two treatment arms after confirming
        eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged
        showering) with uncovered surgical wounds. Group B will be advised to follow traditional
        delayed bathing with covered wounds.
  
        Patients will have follow-up with data collection at two, six and 12 weeks post-operatively.
        The primary outcome measure will be patient satisfaction as measured by a Likert Scale. The
        Likert Scale as utilized will be a patient reported outcome measure consisting of one
        question allowing the subject to express their attitude towards a particular subject: "How
        satisfied are you with your surgical treatment" with possible answers consisting of: "very
        satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", and "very unsatisfied".
        The secondary outcome measures will be development of an infection (subcategorized as either
        superficial or deep) and development of peri-incisional inflammation (eg. adhesive rash).
  
        Primary Objective: The primary objective of the study is to compare patient satisfaction as
        measured using a Likert Scale associated with early and delayed surgical site bathing.
  
        Secondary Objectives: The secondary objective is to compare the infection rate of orthopaedic
        surgical wounds between early and delayed bathing.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  measure: Patient satisfaction associated with early and delayed surgical site bathing
  time frame: Weeks 2, 6 and 12 post surgery
  description: The primary endpoint of the study will be a statistically significant difference in patient satisfaction as measured using a Likert Scale between the two groups. Scale will be on scale 0-10. A score of 10 will be "Very Satisfied" and a score of 0 will be "Very Dissatisfied."
  measure: Infection rate of orthopaedic surgical wounds between early and delayed bathing
  time frame: Weeks 12 post surgery
  description: The secondary endpoint in this study will be a statistically significant or clinically important difference in infection rate of orthopaedic surgical wounds between the early and delayed bathing groups
  arm group label: Delayed Bathing
  arm group type: Active Comparator
  description: Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
  arm group label: Early Bathing
  arm group type: Active Comparator
  description: Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.
  intervention type: Other
  intervention name: Time to bathing (delayed)
  description: Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
  arm group label: Delayed Bathing
  intervention type: Other
  intervention name: Time to bathing (early)
  description: Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.
  arm group label: Early Bathing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: William M Ricci, MD
  role: Principal Investigator
  affiliation: Hospital for Special Surgery, New York
  last name: William M Ricci, MD
  phone: 212-606-1026
  email: ricciw@hss.edu
  last name: Craig E Klinger, BA
  phone: 212-606-1641
  email: klingerc@hss.edu
  responsible party type: Principal Investigator
  investigator affiliation: Hospital for Special Surgery, New York
  investigator full name: William Ricci
  investigator title: Chief Orthopaedic Trauma Service
  mesh term: Wound Infection
  mesh term: Surgical Wound Infection
  mesh term: Wounds and Injuries
  mesh term: Surgical Wound
  sharing ipd: Undecided