<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/NCT03289247</url>
  </required_header>
  <id_info>
    <org_study_id>HVH-SBTKA-Adhaesive</org_study_id>
    <nct_id>NCT03289247</nct_id>
  </id_info>
  <brief_title>Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty</brief_title>
  <official_title>A Prospective Single-blinded Randomized Controlled Study Evaluating Efficacy of Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</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>
      The study's primary objective is to compare the following parameters between wound closure&#xD;
      following primary TKA with and without supplement tissue adhesive (Leukosan®):&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prolonged wound drainage following total joint replacement surgery has been shown to be a&#xD;
      predictor of Periprosthetic Joint Infection (PJI) 1-3. Several studies have highlighted this&#xD;
      subject, and estimates of the risk of postoperative infection range from 1.3% to 50% among&#xD;
      patients with persistent wound drainage 4. Such infections can be one of the most challenging&#xD;
      complications following joint replacement surgery and is one of the leading causes of&#xD;
      revision surgery following primary hip and knee arthroplasty 5,6.&#xD;
&#xD;
      Several patient-related factors have been associated with delayed wound healing and increased&#xD;
      risk of infection following joint replacement surgery. Obesity 4,7, diabetes 8, smoking 9,10&#xD;
      and autoimmune disease 11 have been shown to have a detrimental effect on wound healing.&#xD;
      Recently there has also been reports that patients with hypertension 12 have impaired wound&#xD;
      healing following total hip arthroplasty (THA) and total knee arthroplasty (TKA).&#xD;
&#xD;
      Surgery related factors such as surgical approach, pneumatic tourniquet time and use of&#xD;
      peri-articular local anesthesia have also been shown to have an effect on postoperative wound&#xD;
      oozing 9,13.&#xD;
&#xD;
      Finally, several pharmacological factors, such as thromboembolic chemoprophylaxis 4, steroid&#xD;
      treatment 9,14 and possibly statins 15,16 might also influence wound healing.&#xD;
&#xD;
      In recent years tissue adhesives for wound closure have been introduced as a replacement or a&#xD;
      supplement to conventional closure techniques. Currently very few studies investigate the&#xD;
      effect of such tissue adhesives in Total Knee Arthroplasty, and high quality randomized&#xD;
      controlled trials (RCT) are lacking.&#xD;
&#xD;
      In this project we wish to:&#xD;
&#xD;
      Evaluate the effect of supplemental wound closure using a high viscosity tissue adhaesive&#xD;
      (Leukosan®) in primary TKA with respect to postoperative wound drainage and wound healing.&#xD;
&#xD;
      This project is carried out as a randomized single-blinded controlled trial, in which the&#xD;
      clinical outcomes after wound closure following primary bilateral simultaneous TKA with&#xD;
      either 1) standard 3-layer closure methods with skin staples or 2) 3-layer closure methods&#xD;
      with skin staples supplemented with tissue adhesive (Leukosan®) are compared.&#xD;
&#xD;
      After written informed consent is obtained patients scheduled for a primary bilateral&#xD;
      simultaneous TKA will be enrolled in this study and left knee will be randomized to receive&#xD;
      either 1) standard 3-layer closure methods with skin staples or 2) 3-layer closure methods&#xD;
      with skin staples supplemented with tissue adhesive (Leukosan®), with the opposite treatment&#xD;
      on the contralateral knee. All patients will receive AGC total knee prosthesis in both knees&#xD;
      (department standard). The standard 3-layer closure consist of: size 2 coated VICRYL® Plus&#xD;
      Antibacterial suture for capsule closure, size 2-0 coated VICRYL® Plus Antibacterial suture&#xD;
      for subcutaneous tissue closure and stainless steel staples using PROXIMATE® Fixed-Head&#xD;
      stapler for cutaneous closure. Wound oozing will be assessed by project nurses during&#xD;
      postoperative day 1-3 as well as patient reported wound oozing on postoperative day 3-21.&#xD;
      Wound healing will be assessed using ASEPSIS 17,18 score 3 weeks postoperatively.&#xD;
&#xD;
      Range of motion (ROM) will also be recorded at 3 months postoperatively. Allocation of the&#xD;
      participants to one of the two treatment groups is done intraoperatively after initial&#xD;
      incision has been made. Participants as well as the research coordinator handling the&#xD;
      collected questionnaires postoperatively and evaluating wound healing are all unaware of&#xD;
      which method was used for skin closure.&#xD;
&#xD;
      Recruitment of participants to this project is expected to begin in September 2015 or as soon&#xD;
      as permission from the Regional Ethics Committee and the Danish Data Protections Agency is&#xD;
      obtained. A total of 30 participants are to be included at our institution. Recruitment is&#xD;
      expected completed after a maximum period of 1.5 years. The project is expected to be&#xD;
      completed 1 year after recruitment of the last participant (2018).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2017</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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Investigator evaluating primary outcome is blinded to intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Wound discharge during stay</measure>
    <time_frame>3 days post op</time_frame>
    <description>The wound will be defined as actively oozing, if the standard bandage Mepilex Border Post-op®, is soaked to the border. Bandages soaked to the border will be replaced. Number of replaced bandages for each knee will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ASEPSIS score</measure>
    <time_frame>3 weeks post op</time_frame>
    <description>Wound healing score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Infection</condition>
  <condition>Arthroplasty Complications</condition>
  <arm_group>
    <arm_group_label>Regular</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular closure:&#xD;
The standard 3-layer closure is performed using: 1) size 2 coated VICRYL® Plus Antibacterial suture for capsule closure 2) size 2-0 coated VICRYL® Plus Antibacterial suture for subcutaneous tissue closure and 3) stainless steel stables using PROXIMATE® Fixed-Head stapler for cutaneous closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Additional tissue adhaesive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The standard 3-layer closure is performed using: 1) size 2 coated VICRYL® Plus Antibacterial suture for capsule closure 2) size 2-0 coated VICRYL® Plus Antibacterial suture for subcutaneous tissue closure and 3) stainless steel stables using PROXIMATE® Fixed-Head stapler for cutaneous closure. tissue adhesive (Leukosan®) is applied on top of the staples according to manufacturer instructions. One layer (one tube) of tissue adhesive is applied following air-drying for 30 seconds, followed by a placement of a second layer with a second layer (one tube), and a second air-drying period of 60 seconds</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tissue adhesive (Leukosan®)</intervention_name>
    <description>Tissue ahaesive</description>
    <arm_group_label>Additional tissue adhaesive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Patient &gt; 18 years of age.&#xD;
&#xD;
          -  Patients determined to be suitable for primary simultaneous bilateral TKA based on&#xD;
             physical exam and medical history including the following:&#xD;
&#xD;
             o Osteoarthritis (OA)&#xD;
&#xD;
          -  Patient is skeletally mature.&#xD;
&#xD;
          -  Patient is willing and able to provide written informed consent.&#xD;
&#xD;
          -  Participants must be able to speak and understand Danish&#xD;
&#xD;
          -  Patient is willing and able to cooperate in the required post-operative therapy.&#xD;
&#xD;
          -  Patient is willing and able to complete scheduled follow-up evaluations as described&#xD;
             in the Informed Consent.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Patients with previous open knee surgery on either knee (i.e., osteotomy,&#xD;
             unicompartemental arthroplasty, osteosynthesis)&#xD;
&#xD;
          -  Patients with previous major trauma to either knee resulting in deformity og scarring.&#xD;
&#xD;
          -  Patients receiving treatment for DVT or PE postoperatively.&#xD;
&#xD;
          -  Patients with known allergy to skin adhesives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Kirill Gromov</investigator_full_name>
    <investigator_title>MD, PhD, Ass. professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03289247
org study id: HVH-SBTKA-Adhaesive
nct id: NCT03289247
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study's primary objective is to compare the following parameters between wound closure
      following primary TKA with and without supplement tissue adhesive (Leukosan®):
Prolonged wound drainage following total joint replacement surgery has been shown to be a
      predictor of Periprosthetic Joint Infection (PJI) 1-3. Several studies have highlighted this
      subject, and estimates of the risk of postoperative infection range from 1.3% to 50% among
      patients with persistent wound drainage 4. Such infections can be one of the most challenging
      complications following joint replacement surgery and is one of the leading causes of
      revision surgery following primary hip and knee arthroplasty 5,6.

      Several patient-related factors have been associated with delayed wound healing and increased
      risk of infection following joint replacement surgery. Obesity 4,7, diabetes 8, smoking 9,10
      and autoimmune disease 11 have been shown to have a detrimental effect on wound healing.
      Recently there has also been reports that patients with hypertension 12 have impaired wound
      healing following total hip arthroplasty (THA) and total knee arthroplasty (TKA).

      Surgery related factors such as surgical approach, pneumatic tourniquet time and use of
      peri-articular local anesthesia have also been shown to have an effect on postoperative wound
      oozing 9,13.

      Finally, several pharmacological factors, such as thromboembolic chemoprophylaxis 4, steroid
      treatment 9,14 and possibly statins 15,16 might also influence wound healing.

      In recent years tissue adhesives for wound closure have been introduced as a replacement or a
      supplement to conventional closure techniques. Currently very few studies investigate the
      effect of such tissue adhesives in Total Knee Arthroplasty, and high quality randomized
      controlled trials (RCT) are lacking.

      In this project we wish to:

      Evaluate the effect of supplemental wound closure using a high viscosity tissue adhaesive
      (Leukosan®) in primary TKA with respect to postoperative wound drainage and wound healing.

      This project is carried out as a randomized single-blinded controlled trial, in which the
      clinical outcomes after wound closure following primary bilateral simultaneous TKA with
      either 1) standard 3-layer closure methods with skin staples or 2) 3-layer closure methods
      with skin staples supplemented with tissue adhesive (Leukosan®) are compared.

      After written informed consent is obtained patients scheduled for a primary bilateral
      simultaneous TKA will be enrolled in this study and left knee will be randomized to receive
      either 1) standard 3-layer closure methods with skin staples or 2) 3-layer closure methods
      with skin staples supplemented with tissue adhesive (Leukosan®), with the opposite treatment
      on the contralateral knee. All patients will receive AGC total knee prosthesis in both knees
      (department standard). The standard 3-layer closure consist of: size 2 coated VICRYL® Plus
      Antibacterial suture for capsule closure, size 2-0 coated VICRYL® Plus Antibacterial suture
      for subcutaneous tissue closure and stainless steel staples using PROXIMATE® Fixed-Head
      stapler for cutaneous closure. Wound oozing will be assessed by project nurses during
      postoperative day 1-3 as well as patient reported wound oozing on postoperative day 3-21.
      Wound healing will be assessed using ASEPSIS 17,18 score 3 weeks postoperatively.

      Range of motion (ROM) will also be recorded at 3 months postoperatively. Allocation of the
      participants to one of the two treatment groups is done intraoperatively after initial
      incision has been made. Participants as well as the research coordinator handling the
      collected questionnaires postoperatively and evaluating wound healing are all unaware of
      which method was used for skin closure.

      Recruitment of participants to this project is expected to begin in September 2015 or as soon
      as permission from the Regional Ethics Committee and the Danish Data Protections Agency is
      obtained. A total of 30 participants are to be included at our institution. Recruitment is
      expected completed after a maximum period of 1.5 years. The project is expected to be
      completed 1 year after recruitment of the last participant (2018).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: Investigator evaluating primary outcome is blinded to intervention
measure: Wound discharge during stay
time frame: 3 days post op
description: The wound will be defined as actively oozing, if the standard bandage Mepilex Border Post-op®, is soaked to the border. Bandages soaked to the border will be replaced. Number of replaced bandages for each knee will be recorded.
measure: ASEPSIS score
time frame: 3 weeks post op
description: Wound healing score
arm group label: Regular
arm group type: No Intervention
description: Regular closure:
The standard 3-layer closure is performed using: 1) size 2 coated VICRYL® Plus Antibacterial suture for capsule closure 2) size 2-0 coated VICRYL® Plus Antibacterial suture for subcutaneous tissue closure and 3) stainless steel stables using PROXIMATE® Fixed-Head stapler for cutaneous closure.
arm group label: Additional tissue adhaesive
arm group type: Experimental
description: The standard 3-layer closure is performed using: 1) size 2 coated VICRYL® Plus Antibacterial suture for capsule closure 2) size 2-0 coated VICRYL® Plus Antibacterial suture for subcutaneous tissue closure and 3) stainless steel stables using PROXIMATE® Fixed-Head stapler for cutaneous closure. tissue adhesive (Leukosan®) is applied on top of the staples according to manufacturer instructions. One layer (one tube) of tissue adhesive is applied following air-drying for 30 seconds, followed by a placement of a second layer with a second layer (one tube), and a second air-drying period of 60 seconds
intervention type: Device
intervention name: tissue adhesive (Leukosan®)
description: Tissue ahaesive
arm group label: Additional tissue adhaesive
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Kirill Gromov
investigator title: MD, PhD, Ass. professor
sharing ipd: Undecided