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/NCT06011629</url>
    </required_header>
    <id_info>
      <org_study_id>23050308</org_study_id>
      <nct_id>NCT06011629</nct_id>
    </id_info>
    <brief_title>Aquacel Hypersensitivity Dressing in TJAs</brief_title>
    <official_title>Prospective Evaluation of Type IV Hypersensitivity Reactions After Aquacel Dressing Application in Partial and Total Joint Arthroplasty Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rush University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rush University Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this multi-surgeon, single institution study is to prospectively evaluate the&#xD;
        incidence of allergic contact dermatitis (ACD) following application of AQUACEL Ag, a&#xD;
        silver-containing hydrofiber dressing, in total hip and knee arthroplasty patients.&#xD;
        Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who&#xD;
        received a Aquacel dressing postoperatively.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Level I: Prospective Cohort Study Patients will be recruited into the study after completing&#xD;
        a standard questionnaire for pre-operative enrollment. After meeting inclusion criteria and&#xD;
        passing the screening process, the patient will be enrolled into the study. Variables of&#xD;
        interest related to sociodemographic status, operative details and postoperative outcomes.&#xD;
  &#xD;
        Relevant variables that will be collected include:&#xD;
  &#xD;
        Inclusion Criteria:&#xD;
  &#xD;
          1. Patients older than 18 years that underwent primary total hip arthroplasty (THA)&#xD;
  &#xD;
          2. Patients older than 18 years that underwent primary total or unicompartmental knee&#xD;
             arthroplasty (TKA/UKA)&#xD;
  &#xD;
        Exclusion Criteria:&#xD;
  &#xD;
          1. Revision surgery&#xD;
  &#xD;
          2. Prior history of allergic contact dermatitis&#xD;
  &#xD;
          3. Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op&#xD;
  &#xD;
          4. Occupational exposure to surgical dressings&#xD;
  &#xD;
          5. Documented history of silver allergy&#xD;
  &#xD;
        Sample Size:&#xD;
  &#xD;
        A power analysis to determine how many patients need to be enrolled was performed with a rate&#xD;
        of ACD in the AQUACEL Ag naïve group and the AQAUCEL Ag-exposed group of 1% and 2%,&#xD;
        respectively. A one-tailed z-test of proportions between the two groups with 80% power, a 5%&#xD;
        level of significance, and 1:1 allocation ratio, requires a sample size of 314 (157 per&#xD;
        group). To account for 20% attrition rate amongst both cohorts, we plan to enroll 400&#xD;
        patients (200 each group).&#xD;
  &#xD;
        Demographic/Patient Specific Data Collected:&#xD;
  &#xD;
        Age, Sex, Body Mass Index (BMI), Allergy History, Past Surgical History, Prior exposure to&#xD;
        surgical dressing (Either occupational (i.e. healthcare worker) or as a patient), Number of&#xD;
        prior arthroplasty surgeries with AQUACEL Ag dressing (i.e. 0, 1, 2, 3), Past adverse&#xD;
        reaction to AQUACEL Ag dressing, Any Adverse Skin Reactions with any past adhesive exposure&#xD;
  &#xD;
        Operative details:&#xD;
  &#xD;
        Surgical date, Operation/Laterality (THA/TKA/UKA, Left/Right), Length of incision, Patient&#xD;
        reported skin check at 1 week (via picture from patient if wound issue/skin reaction&#xD;
        present), Size of Rash if present, Provider skin Check at 1st post-operative appointment (2-4&#xD;
        weeks post-op), Any Wound Complications&#xD;
  &#xD;
        Primary Outcome Measure:&#xD;
  &#xD;
        The primary outcome is the rate of contact allergic dermatitis or adverse skin reaction at 1&#xD;
        week post op and 1st post operative visit (2-3 weeks after surgery). We will also quantify&#xD;
        time from surgery to reaction onset (Days). We will measure the size of the rash at&#xD;
        post-operative follow up as well as classify the rash according to the classification system&#xD;
        used in prior studies examining ACD.&#xD;
  &#xD;
        Secondary Outcome Measures&#xD;
  &#xD;
          1. Wound complications&#xD;
  &#xD;
          2. Any workup for PJI (Serologic labs (ESR/CRP), arthrocentesis)&#xD;
  &#xD;
          3. Any administration of post-operative antibiotics outside of normal protocol&#xD;
  &#xD;
          4. Return to Operating Room for debridement, manipulation, other surgical interventions&#xD;
  &#xD;
          5. Surgical Site Infection (SSI)&#xD;
  &#xD;
          6. Confirmed Periprosthetic Joint Infection (PJI)&#xD;
  &#xD;
          7. Stiffness requiring Manipulation Under Anesthesia (MUA)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery</measure>
      <time_frame>7 days post surgery</time_frame>
      <description>Using a classification of skin reactions from mild, moderate to severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery</measure>
      <time_frame>2-3 weeks following surgery</time_frame>
      <description>Using a classification of skin reactions from mild, moderate to severe</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Wound complications (if applicable)</measure>
      <time_frame>1 week post surgery</time_frame>
      <description>If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wound complications (if applicable)</measure>
      <time_frame>2-3 weeks after surgery</time_frame>
      <description>If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Contact Allergic Dermatitis</condition>
    <condition>Adverse Skin Reaction</condition>
    <arm_group>
      <arm_group_label>Arthroplasty-naïve Aquacel group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Aquacel dressing but have not had previous joint replacement surgery. Therefore, we consider them the arthroplasty-naïve Aquacel group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prior Aquacel group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All subject's receive the Aquacel dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a Aquacel dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Aquacel dressing</intervention_name>
      <description>Patients will be recruited into the study after completing a standard questionnaire for pre-operative enrollment. After meeting inclusion criteria and passing the screening process, the patient will be enrolled into the study. Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who received a Aquacel dressing postoperatively.</description>
      <arm_group_label>Arthroplasty-naïve Aquacel group</arm_group_label>
      <arm_group_label>Prior Aquacel group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients older than 18 years that underwent primary total hip arthroplasty (THA)&#xD;
  &#xD;
            2. Patients older than 18 years that underwent primary total or unicompartmental knee&#xD;
               arthroplasty (TKA/UKA)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Revision surgery&#xD;
  &#xD;
            2. Prior history of allergic contact dermatitis&#xD;
  &#xD;
            3. Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op&#xD;
  &#xD;
            4. Occupational exposure to surgical dressings&#xD;
  &#xD;
            5. Documented history of silver allergy&#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_contact>
      <last_name>Anne DeBenedetti, MSc</last_name>
      <phone>3124322468</phone>
      <email>anne.debenedetti@rushortho.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Conor Jones, MD</last_name>
      <phone>3124322468</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rush University Medical Center</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anne DeBenedetti, MSc</last_name>
        <phone>312-432-2468</phone>
      </contact>
      <contact_backup>
        <last_name>Conor Jones, MD</last_name>
        <phone>3124322468</phone>
      </contact_backup>
      <investigator>
        <last_name>Vasili Karas, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Craig Della Valle, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 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 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</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>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Dermatitis, Allergic Contact</mesh_term>
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carboxymethylcellulose Sodium</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Once complete, we will share the summary of the data along with study protocol and SAP</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Once the study is fully enrolled</ipd_time_frame>
    </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/NCT06011629
  org study id: 23050308
  nct id: NCT06011629
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The aim of this multi-surgeon, single institution study is to prospectively evaluate the
        incidence of allergic contact dermatitis (ACD) following application of AQUACEL Ag, a
        silver-containing hydrofiber dressing, in total hip and knee arthroplasty patients.
        Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who
        received a Aquacel dressing postoperatively.
  Level I: Prospective Cohort Study Patients will be recruited into the study after completing
        a standard questionnaire for pre-operative enrollment. After meeting inclusion criteria and
        passing the screening process, the patient will be enrolled into the study. Variables of
        interest related to sociodemographic status, operative details and postoperative outcomes.
  
        Relevant variables that will be collected include:
  
        Inclusion Criteria:
  
          1. Patients older than 18 years that underwent primary total hip arthroplasty (THA)
  
          2. Patients older than 18 years that underwent primary total or unicompartmental knee
             arthroplasty (TKA/UKA)
  
        Exclusion Criteria:
  
          1. Revision surgery
  
          2. Prior history of allergic contact dermatitis
  
          3. Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op
  
          4. Occupational exposure to surgical dressings
  
          5. Documented history of silver allergy
  
        Sample Size:
  
        A power analysis to determine how many patients need to be enrolled was performed with a rate
        of ACD in the AQUACEL Ag naïve group and the AQAUCEL Ag-exposed group of 1% and 2%,
        respectively. A one-tailed z-test of proportions between the two groups with 80% power, a 5%
        level of significance, and 1:1 allocation ratio, requires a sample size of 314 (157 per
        group). To account for 20% attrition rate amongst both cohorts, we plan to enroll 400
        patients (200 each group).
  
        Demographic/Patient Specific Data Collected:
  
        Age, Sex, Body Mass Index (BMI), Allergy History, Past Surgical History, Prior exposure to
        surgical dressing (Either occupational (i.e. healthcare worker) or as a patient), Number of
        prior arthroplasty surgeries with AQUACEL Ag dressing (i.e. 0, 1, 2, 3), Past adverse
        reaction to AQUACEL Ag dressing, Any Adverse Skin Reactions with any past adhesive exposure
  
        Operative details:
  
        Surgical date, Operation/Laterality (THA/TKA/UKA, Left/Right), Length of incision, Patient
        reported skin check at 1 week (via picture from patient if wound issue/skin reaction
        present), Size of Rash if present, Provider skin Check at 1st post-operative appointment (2-4
        weeks post-op), Any Wound Complications
  
        Primary Outcome Measure:
  
        The primary outcome is the rate of contact allergic dermatitis or adverse skin reaction at 1
        week post op and 1st post operative visit (2-3 weeks after surgery). We will also quantify
        time from surgery to reaction onset (Days). We will measure the size of the rash at
        post-operative follow up as well as classify the rash according to the classification system
        used in prior studies examining ACD.
  
        Secondary Outcome Measures
  
          1. Wound complications
  
          2. Any workup for PJI (Serologic labs (ESR/CRP), arthrocentesis)
  
          3. Any administration of post-operative antibiotics outside of normal protocol
  
          4. Return to Operating Room for debridement, manipulation, other surgical interventions
  
          5. Surgical Site Infection (SSI)
  
          6. Confirmed Periprosthetic Joint Infection (PJI)
  
          7. Stiffness requiring Manipulation Under Anesthesia (MUA)
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery
  time frame: 7 days post surgery
  description: Using a classification of skin reactions from mild, moderate to severe
  measure: Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery
  time frame: 2-3 weeks following surgery
  description: Using a classification of skin reactions from mild, moderate to severe
  measure: Wound complications (if applicable)
  time frame: 1 week post surgery
  description: If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia
  measure: Wound complications (if applicable)
  time frame: 2-3 weeks after surgery
  description: If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia
  arm group label: Arthroplasty-naïve Aquacel group
  arm group type: Other
  description: All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Aquacel dressing but have not had previous joint replacement surgery. Therefore, we consider them the arthroplasty-naïve Aquacel group.
  arm group label: Prior Aquacel group
  arm group type: Other
  description: All subject's receive the Aquacel dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a Aquacel dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.
  intervention type: Device
  intervention name: Aquacel dressing
  description: Patients will be recruited into the study after completing a standard questionnaire for pre-operative enrollment. After meeting inclusion criteria and passing the screening process, the patient will be enrolled into the study. Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who received a Aquacel dressing postoperatively.
  arm group label: Arthroplasty-naïve Aquacel group
  arm group label: Prior Aquacel group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anne DeBenedetti, MSc
  phone: 3124322468
  email: anne.debenedetti@rushortho.com
  last name: Conor Jones, MD
  phone: 3124322468
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Dermatitis, Allergic Contact
  mesh term: Hypersensitivity
  mesh term: Carboxymethylcellulose Sodium
  sharing ipd: Yes
  ipd description: Once complete, we will share the summary of the data along with study protocol and SAP
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Once the study is fully enrolled