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/NCT06011603</url>
    </required_header>
    <id_info>
      <org_study_id>23041601</org_study_id>
      <nct_id>NCT06011603</nct_id>
    </id_info>
    <brief_title>Prineo Sensitivity Dressing Study</brief_title>
    <official_title>Prospective Evaluation of Type IV Hypersensitivity Reactions After Prineo 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>
        Wound complications can be devastating following total joint arthroplasty, resulting in an&#xD;
        increased practice burden in the form of more frequent follow ups, increased clinic visits&#xD;
        potential for wound dehiscence, superficial infection and deep infection with possible return&#xD;
        to the operating room and revision surgery. Several dressing options are currently on the&#xD;
        market designed to minimize wound complications in addition to traditional dressings,&#xD;
        including negative pressure dressing, antimicrobial dressing, occlusive dressings, and/or&#xD;
        skin adhesives. Prineo dressing (2-octyl cyanoacrylate adhesive (Dermabond) and&#xD;
        n-butyl-2-cyanoacrylate adhesive) has increased in popularity as a dressing option used by&#xD;
        joint arthroplasty surgeons. There is a well-documented adverse allergic response with these&#xD;
        dressings resulting in peri-incisional erythema, urticaria, and/or an eczematous skin&#xD;
        reaction. Recently, Mayman et al reported a rate of 1-1.5%, suggesting a possible rising&#xD;
        incidence of ACD attributable to increased utilization of the specific dressing and&#xD;
        sensitization.&#xD;
  &#xD;
        To our knowledge, no prospective trial has compared the rates of adverse allergic reactions&#xD;
        in Prineo naive patients to patients who have undergone previous total joint arthroplasty&#xD;
        (TJA) and received Prineo dressings in the past. We will utilize a prospective controlled&#xD;
        study design to assess the rate of adverse allergic reactions in patients naive to Prineo&#xD;
        versus those with previous exposure. We will assess rates of allergic reactions at one week&#xD;
        post-op and at their first post-op clinic visit, 2 to 3 weeks post-op, tracking rates of&#xD;
        allergic reactions as well as severity, the use of post-operative antibiotics, work up for&#xD;
        prosthetic joint infection, return to the operating room, surgical site infection, confirmed&#xD;
        prosthetic joint infection and stiffness requiring manipulation under anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Level I: Prospective Cohort Study&#xD;
  &#xD;
        Patients will be recruited into the study after completing a standard questionnaire for&#xD;
        pre-operative enrollment. After meeting inclusion criteria and passing the screening process,&#xD;
        the patient will be enrolled into the study. Variables of interest related to&#xD;
        sociodemographic status, operative details and postoperative outcomes will be taken from the&#xD;
        electronic medical records associated with Midwest Orthopedics at Rush and Rush University&#xD;
        Medical Center will be performed. This review will comprise patients of multiple providers at&#xD;
        Midwest Orthopedics at Rush, including Dr. Vasili Karas, Dr. Richard Berger and Dr. Brett&#xD;
        Levine. 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. Occupational exposure to glues and surgical dressing&#xD;
  &#xD;
          4. Prior operative procedure non-TJA with use of Prineo dressing&#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 surgical dressing naïve group and the surgical dressing-exposed group of 1% and&#xD;
        2%, respectively. A one-tailed z-test of proportions between the two groups with 80% power, a&#xD;
        5% 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;
        glue/mesh dressing (Either occupational (i.e. healthcare worker) or as a patient), Number of&#xD;
        prior arthroplasty surgeries with Prineo dressing (i.e. 0, 1, 2, 3), Past adverse reaction to&#xD;
        Prineo 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 Prineo-related ACD.[9]&#xD;
  &#xD;
        Classification of 2-Octyl Cyanoacrylate Reactions[12]&#xD;
  &#xD;
        Mild&#xD;
  &#xD;
        Erythema, infiltration, possible papules&#xD;
  &#xD;
        Moderate&#xD;
  &#xD;
        Erythema, infiltration, papules and vesicles&#xD;
  &#xD;
        Severe&#xD;
  &#xD;
        Spreading reaction (outside area of application), bullous reaction, extreme pruritus&#xD;
  &#xD;
        Secondary Outcome Measures&#xD;
  &#xD;
        Wound complications Any workup for PJI (Serologic labs (ESR/CRP), arthrocentesis) Any&#xD;
        administration of post-operative antibiotics outside of normal protocol Return to Operating&#xD;
        Room for debridement, manipulation, other surgical interventions Surgical Site Infection&#xD;
        (SSI) Confirmed Periprosthetic Joint Infection (PJI) Stiffness requiring Manipulation Under&#xD;
        Anesthesia (MUA)&#xD;
  &#xD;
        Patient Enrollment:&#xD;
  &#xD;
        Patients will be enrolled from the clinics of the surgeons in the division of Hip and Knee&#xD;
        Replacement at Midwest Orthopaedics at Rush. These surgeons include Dr. Brett Levine, Dr.&#xD;
        Vasili Karas, and Dr. Richard Berger. The clinical research coordinator will screen each&#xD;
        surgeon'supcoming surgical schedule two weeks in advance. Patients undergoing primary TJA at&#xD;
        Rush University Medical Center, meeting the inclusion and exclusion criteria, will be&#xD;
        contacted via telephone or in clinic and will be explained the purposes of this&#xD;
        investigation. If the patient is willing to participate, they will give verbal consent prior&#xD;
        to the day of their surgical procedure. Informed consent will be obtained by either the&#xD;
        clinical research coordinator or physician on the surgical team.&#xD;
  &#xD;
        Informed Consent:&#xD;
  &#xD;
        The study staff will review the informed consent document and study requirements with the&#xD;
        patient and answer any questions the patient may have over the telephone or in a private&#xD;
        clinic area. The patient will have the opportunity to review the information packet and do&#xD;
        his/her own research on the topic if desired. Once all of the patients' questions have been&#xD;
        answered and if the patient has given verbal consent, he/she will be enrolled in the study.&#xD;
  &#xD;
        Sample Size: A power analysis has been completed using allergic reaction as the primary&#xD;
        endpoint. This analysis was based on an investigation by Mayman et al 9 that demonstrated a&#xD;
        wound complication rate of 1% in the TJA setting using Prineo dressings. We feel an increase&#xD;
        in allergic reaction from 1% in Prineo naive patients to 2% in patients with previous Prineo&#xD;
        use will be clinically significant. Therefore, 200 patients per treatment group will provide&#xD;
        an overall type 1 error rate (alpha) of 0.05 and power of at least 80% . Our institution&#xD;
        serves as a major referral center in the region for total joint arthroplasty, and we perform&#xD;
        over hundreds of primary total joint replacements annually. Therefore, we believe the&#xD;
        required sample size can be achieved in approximately one year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">December 1, 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>Allergic Reaction</condition>
    <condition>Wound Complication</condition>
    <arm_group>
      <arm_group_label>Prineo naive 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 Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prineo-exposed group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo 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>Prineo dressing</intervention_name>
      <description>Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.</description>
      <arm_group_label>Prineo naive group</arm_group_label>
      <arm_group_label>Prineo-exposed group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 18 years that underwent primary total joint arthroplasty (total&#xD;
               hip, total knee, partial knee)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Revision surgery&#xD;
  &#xD;
            -  Prior history of allergic contact dermatitis&#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>Vasili Karas, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rush University Medical Center</affiliation>
    </overall_official>
    <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>
      <investigator>
        <last_name>Vasili Karas, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Brett Levine, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Richard Berger, 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>Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Once complete, we will share the summary of the data</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/NCT06011603
  org study id: 23041601
  nct id: NCT06011603
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Wound complications can be devastating following total joint arthroplasty, resulting in an
        increased practice burden in the form of more frequent follow ups, increased clinic visits
        potential for wound dehiscence, superficial infection and deep infection with possible return
        to the operating room and revision surgery. Several dressing options are currently on the
        market designed to minimize wound complications in addition to traditional dressings,
        including negative pressure dressing, antimicrobial dressing, occlusive dressings, and/or
        skin adhesives. Prineo dressing (2-octyl cyanoacrylate adhesive (Dermabond) and
        n-butyl-2-cyanoacrylate adhesive) has increased in popularity as a dressing option used by
        joint arthroplasty surgeons. There is a well-documented adverse allergic response with these
        dressings resulting in peri-incisional erythema, urticaria, and/or an eczematous skin
        reaction. Recently, Mayman et al reported a rate of 1-1.5%, suggesting a possible rising
        incidence of ACD attributable to increased utilization of the specific dressing and
        sensitization.
  
        To our knowledge, no prospective trial has compared the rates of adverse allergic reactions
        in Prineo naive patients to patients who have undergone previous total joint arthroplasty
        (TJA) and received Prineo dressings in the past. We will utilize a prospective controlled
        study design to assess the rate of adverse allergic reactions in patients naive to Prineo
        versus those with previous exposure. We will assess rates of allergic reactions at one week
        post-op and at their first post-op clinic visit, 2 to 3 weeks post-op, tracking rates of
        allergic reactions as well as severity, the use of post-operative antibiotics, work up for
        prosthetic joint infection, return to the operating room, surgical site infection, confirmed
        prosthetic joint infection and stiffness requiring manipulation under anesthesia.
  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 will be taken from the
        electronic medical records associated with Midwest Orthopedics at Rush and Rush University
        Medical Center will be performed. This review will comprise patients of multiple providers at
        Midwest Orthopedics at Rush, including Dr. Vasili Karas, Dr. Richard Berger and Dr. Brett
        Levine. 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. Occupational exposure to glues and surgical dressing
  
          4. Prior operative procedure non-TJA with use of Prineo dressing
  
        Sample Size:
  
        A power analysis to determine how many patients need to be enrolled was performed with a rate
        of ACD in the surgical dressing naïve group and the surgical dressing-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
        glue/mesh dressing (Either occupational (i.e. healthcare worker) or as a patient), Number of
        prior arthroplasty surgeries with Prineo dressing (i.e. 0, 1, 2, 3), Past adverse reaction to
        Prineo 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 Prineo-related ACD.[9]
  
        Classification of 2-Octyl Cyanoacrylate Reactions[12]
  
        Mild
  
        Erythema, infiltration, possible papules
  
        Moderate
  
        Erythema, infiltration, papules and vesicles
  
        Severe
  
        Spreading reaction (outside area of application), bullous reaction, extreme pruritus
  
        Secondary Outcome Measures
  
        Wound complications Any workup for PJI (Serologic labs (ESR/CRP), arthrocentesis) Any
        administration of post-operative antibiotics outside of normal protocol Return to Operating
        Room for debridement, manipulation, other surgical interventions Surgical Site Infection
        (SSI) Confirmed Periprosthetic Joint Infection (PJI) Stiffness requiring Manipulation Under
        Anesthesia (MUA)
  
        Patient Enrollment:
  
        Patients will be enrolled from the clinics of the surgeons in the division of Hip and Knee
        Replacement at Midwest Orthopaedics at Rush. These surgeons include Dr. Brett Levine, Dr.
        Vasili Karas, and Dr. Richard Berger. The clinical research coordinator will screen each
        surgeon'supcoming surgical schedule two weeks in advance. Patients undergoing primary TJA at
        Rush University Medical Center, meeting the inclusion and exclusion criteria, will be
        contacted via telephone or in clinic and will be explained the purposes of this
        investigation. If the patient is willing to participate, they will give verbal consent prior
        to the day of their surgical procedure. Informed consent will be obtained by either the
        clinical research coordinator or physician on the surgical team.
  
        Informed Consent:
  
        The study staff will review the informed consent document and study requirements with the
        patient and answer any questions the patient may have over the telephone or in a private
        clinic area. The patient will have the opportunity to review the information packet and do
        his/her own research on the topic if desired. Once all of the patients' questions have been
        answered and if the patient has given verbal consent, he/she will be enrolled in the study.
  
        Sample Size: A power analysis has been completed using allergic reaction as the primary
        endpoint. This analysis was based on an investigation by Mayman et al 9 that demonstrated a
        wound complication rate of 1% in the TJA setting using Prineo dressings. We feel an increase
        in allergic reaction from 1% in Prineo naive patients to 2% in patients with previous Prineo
        use will be clinically significant. Therefore, 200 patients per treatment group will provide
        an overall type 1 error rate (alpha) of 0.05 and power of at least 80% . Our institution
        serves as a major referral center in the region for total joint arthroplasty, and we perform
        over hundreds of primary total joint replacements annually. Therefore, we believe the
        required sample size can be achieved in approximately one year.
  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: Prineo naive 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 Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.
  arm group label: Prineo-exposed group
  arm group type: Other
  description: All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo 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: Prineo dressing
  description: Prineo dressing is a common dressing option used in Joint Arthroplasty surgery. It is an adhesive dressing growing in popularity that is thought to lead to reinforced tension across the wound while also decreasing the skin edge ischemia.
  arm group label: Prineo naive group
  arm group label: Prineo-exposed group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Vasili Karas, MD
  role: Principal Investigator
  affiliation: Rush University Medical Center
  last name: Anne DeBenedetti, MSc
  phone: 3124322468
  email: anne.debenedetti@rushortho.com
  last name: Conor Jones, MD
  phone: 3124322468
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Hypersensitivity
  sharing ipd: Yes
  ipd description: Once complete, we will share the summary of the data
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Once the study is fully enrolled