<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/NCT01667874</url>
  </required_header>
  <id_info>
    <org_study_id>102635</org_study_id>
    <nct_id>NCT01667874</nct_id>
  </id_info>
  <brief_title>Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections</brief_title>
  <official_title>Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if Collatamp, a small flat sponge soaked with&#xD;
      antibiotics will help to improve the success rate of the treatment of acute joint infections&#xD;
      after a joint replacement surgery. Our hypothesis is that those patients receiving the&#xD;
      Collatamp sponges will have an improved success with respect to the eradication of infection&#xD;
      at one year following treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While total hip and knee replacement surgery remains a highly successful treatment for&#xD;
      arthritis of the hip and knee, infection following a joint replacement still remains an&#xD;
      issue, occurring in approximately 1-2% of joint replacement patients. Treatment of infection&#xD;
      remains very difficult with the successful elimination of the infection being quite variable,&#xD;
      ranging from as low as 10% to approximately 85-90%, following a two stage revision. A two&#xD;
      stage revision involves removing the joint replacement implant and replacing it with a cement&#xD;
      spacer until the surgeon is comfortable that the infection has been eliminated. In the second&#xD;
      part of a two stage revision the cement spacer is removed and a new joint replacement implant&#xD;
      is inserted in the joint space. In particular, the treatment of an acute infection, that is,&#xD;
      infection occurring in the early postoperative period or in a patient with less than two&#xD;
      weeks duration of symptoms, is particularly problematic. As a first line of treatment,&#xD;
      surgeons often perform an irrigation (washing out a wound with a stream of water) and&#xD;
      debridement (the surgical removal of contaminated tissue) surrounding the joint in the hopes&#xD;
      of preserving the joint replacement, although the success rate is highly variable. Most&#xD;
      treatment routines involve irrigation of the joint with copious (large) amounts of fluid,&#xD;
      removal of infected soft tissue, replacement of any removable parts (example plastic liners&#xD;
      or femoral heads) and then intravenous antibiotics for a prolonged period of time (6-8&#xD;
      weeks). It is thought that part of the reason for failure with this form of treatment is the&#xD;
      inability to adequately provide local antibiotics to the joint environment while the joint&#xD;
      replacement components are in place. In particular, the formation of a bacterial slime by the&#xD;
      infecting organism, which can attach itself to the metallic components, is thought to be a&#xD;
      major hindrance to removing infection. In theory, the ability to infuse local antibiotics to&#xD;
      the joint could prove advantageous to the treatment of joint replacement infections.&#xD;
&#xD;
      Collatamp® is a like a small flat sponge soaked with antibiotics that delivers a consistent&#xD;
      dose of fast-release antibiotics called Gentamicin Sulphate (2.0 mg/cm2). The antibiotic is&#xD;
      concentrated locally in the tissue around the joint replacement. The sponge is reabsorbed by&#xD;
      the body and therefore does not need to be surgically removed. Collatamp® sponges have been&#xD;
      utilized in the clinical setting for over 20 yrs. This material has been used in treatment of&#xD;
      other orthopaedic, general surgery, and cardiac infections, but has not been studied in the&#xD;
      setting of infected total joint replacements. The purpose of this study is to examine the use&#xD;
      of CollatampTM sponges as an addition to the treatment of acute joint infections after a&#xD;
      total joint replacement surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty in recruiting patients for the study&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 1, 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 3</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eradication of infection</measure>
    <time_frame>One year</time_frame>
    <description>Success will be defined as those patients whose implant is still in place at one year and demonstrate no clinical signs or symptoms of infection. Eradication of infection will be defined as those patients whose inflammatory markers (ESR and CRP)have returned to normal values following one year treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>No Collatamp sponge</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Joint infection treated without the use of the Collatamp G sponge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collatamp G sponge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Collatamp G Gentamicin impregnated sponge for the treatment of early total joint infections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Collatamp G sponge</intervention_name>
    <description>Collatamp G is an antibiotic impregnated sponge</description>
    <arm_group_label>Collatamp G sponge</arm_group_label>
    <other_name>Gentamicin Sulphate 2.0 mg/cm2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an acute total joint infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of alcoholism&#xD;
&#xD;
          -  Unable to return for follow-up&#xD;
&#xD;
          -  Refuses to participate in the study&#xD;
&#xD;
          -  Does not speak English&#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>Richard McCalden, MD, MPhil(Edin), F.R.C.S.(C)</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre - University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Stemberger A, Grimm H, Bader F, Rahn HD, Ascherl R. Local treatment of bone and soft tissue infections with the collagen-gentamicin sponge. Eur J Surg Suppl. 1997;(578):17-26. No abstract available.</citation>
    <PMID>9167145</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>February 14, 2017</last_update_submitted>
  <last_update_submitted_qc>February 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Richard McCalden</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Randomized controlled trial</keyword>
  <keyword>early joint infection</keyword>
  <keyword>gentamicin impregnated sponges</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gentamicins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01667874
org study id: 102635
nct id: NCT01667874
lead sponsor: 
has dmc: No
The purpose of this study is to determine if Collatamp, a small flat sponge soaked with
      antibiotics will help to improve the success rate of the treatment of acute joint infections
      after a joint replacement surgery. Our hypothesis is that those patients receiving the
      Collatamp sponges will have an improved success with respect to the eradication of infection
      at one year following treatment.
While total hip and knee replacement surgery remains a highly successful treatment for
      arthritis of the hip and knee, infection following a joint replacement still remains an
      issue, occurring in approximately 1-2% of joint replacement patients. Treatment of infection
      remains very difficult with the successful elimination of the infection being quite variable,
      ranging from as low as 10% to approximately 85-90%, following a two stage revision. A two
      stage revision involves removing the joint replacement implant and replacing it with a cement
      spacer until the surgeon is comfortable that the infection has been eliminated. In the second
      part of a two stage revision the cement spacer is removed and a new joint replacement implant
      is inserted in the joint space. In particular, the treatment of an acute infection, that is,
      infection occurring in the early postoperative period or in a patient with less than two
      weeks duration of symptoms, is particularly problematic. As a first line of treatment,
      surgeons often perform an irrigation (washing out a wound with a stream of water) and
      debridement (the surgical removal of contaminated tissue) surrounding the joint in the hopes
      of preserving the joint replacement, although the success rate is highly variable. Most
      treatment routines involve irrigation of the joint with copious (large) amounts of fluid,
      removal of infected soft tissue, replacement of any removable parts (example plastic liners
      or femoral heads) and then intravenous antibiotics for a prolonged period of time (6-8
      weeks). It is thought that part of the reason for failure with this form of treatment is the
      inability to adequately provide local antibiotics to the joint environment while the joint
      replacement components are in place. In particular, the formation of a bacterial slime by the
      infecting organism, which can attach itself to the metallic components, is thought to be a
      major hindrance to removing infection. In theory, the ability to infuse local antibiotics to
      the joint could prove advantageous to the treatment of joint replacement infections.

      Collatamp® is a like a small flat sponge soaked with antibiotics that delivers a consistent
      dose of fast-release antibiotics called Gentamicin Sulphate (2.0 mg/cm2). The antibiotic is
      concentrated locally in the tissue around the joint replacement. The sponge is reabsorbed by
      the body and therefore does not need to be surgically removed. Collatamp® sponges have been
      utilized in the clinical setting for over 20 yrs. This material has been used in treatment of
      other orthopaedic, general surgery, and cardiac infections, but has not been studied in the
      setting of infected total joint replacements. The purpose of this study is to examine the use
      of CollatampTM sponges as an addition to the treatment of acute joint infections after a
      total joint replacement surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Eradication of infection
time frame: One year
description: Success will be defined as those patients whose implant is still in place at one year and demonstrate no clinical signs or symptoms of infection. Eradication of infection will be defined as those patients whose inflammatory markers (ESR and CRP)have returned to normal values following one year treatment.
arm group label: No Collatamp sponge
arm group type: No Intervention
description: Joint infection treated without the use of the Collatamp G sponge.
arm group label: Collatamp G sponge
arm group type: Experimental
description: Use of Collatamp G Gentamicin impregnated sponge for the treatment of early total joint infections
intervention type: Drug
intervention name: Collatamp G sponge
description: Collatamp G is an antibiotic impregnated sponge
arm group label: Collatamp G sponge
other name: Gentamicin Sulphate 2.0 mg/cm2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard McCalden, MD, MPhil(Edin), F.R.C.S.(C)
role: Principal Investigator
affiliation: London Health Sciences Centre - University Hospital
facility: 
country: Canada
citation: Stemberger A, Grimm H, Bader F, Rahn HD, Ascherl R. Local treatment of bone and soft tissue infections with the collagen-gentamicin sponge. Eur J Surg Suppl. 1997;(578):17-26. No abstract available.
PMID: 9167145
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Richard McCalden
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Gentamicins
sharing ipd: No