<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/NCT04422119</url>
  </required_header>
  <id_info>
    <org_study_id>AC-16-016-CEIMPS</org_study_id>
    <nct_id>NCT04422119</nct_id>
  </id_info>
  <brief_title>Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis</brief_title>
  <acronym>APOSIT-PTG</acronym>
  <official_title>Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Germans Trias i Pujol Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundació Institut Germans Trias i Pujol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Germans Trias i Pujol 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 aim of the study is: to evaluate the efficacy of two post-operative dressings in the&#xD;
      management of the surgical wounds in patients who received a knee prosthesis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomised, controlled, clinical trial on patients who received a primary knee&#xD;
      prosthesis in 2018-2019. Treatment group was given a multi-layer foam dressing with Safetac.&#xD;
      The control group received standard treatment with povidone-iodine and a gauze dressing with&#xD;
      plaster. 50 patients was needed for sufficient power. Primary outcome measures were; the&#xD;
      characteristics of the surgical wound, patient reported comfort and adaptability according to&#xD;
      the physiotherapist. Secondary outcome measures were: the clinical status and quality of life&#xD;
      level according to the Western Ontario and McMaster Universities Osteoarthritis Index&#xD;
      (WOMAC). Statistical analysis was performed by using IBM SPSS version 25, with a statistical&#xD;
      significance of 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of dressing changes</measure>
    <time_frame>From fist day post-surgery to 7th postoperative day</time_frame>
    <description>Number of dressing applications to the patients required</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in patient comfort</measure>
    <time_frame>From fist day post-surgery to 7th postoperative day</time_frame>
    <description>Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Surgical Wound</condition>
  <condition>Knee Disease</condition>
  <arm_group>
    <arm_group_label>Multi-layer foam dressing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multi-Foam dressing</intervention_name>
    <description>Application of a multi-layer foam dressing with Safetac in surgical wound</description>
    <arm_group_label>Multi-layer foam dressing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Care of surgical wound with povidone-iodine and a gauze dressing with plaster.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgical intervention of total primary knee prosthesis&#xD;
&#xD;
          -  Informed consent approved and signed by participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sensitivity or allergy to study dressings&#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>Antonia Salmerón-Ramírez, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Germans Trias i Pujol University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sergio Alonso-Fernández, RN,MSN,PhD</last_name>
    <phone>0034934978437</phone>
    <email>salonso.germanstrias@gencat.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Antonia Salmerón-Ramírez, RN</last_name>
    <phone>0034695560386</phone>
    <email>asalmeronr.germanstrias@gencat.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergio Alonso-Fernández, RN,MSN,PhD</last_name>
      <phone>0034934978437</phone>
      <email>salonso.germanstrias@gencat.cat</email>
    </contact>
    <contact_backup>
      <last_name>Antonia Salmerón-Ramírez, RN</last_name>
      <phone>0034934973497</phone>
    </contact_backup>
    <investigator>
      <last_name>Antonia Salmerón-Ramírez, RN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>José Antonio Hernández-Hermoso, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Juan Alberto Estévez-Moreno, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Miquel Àngel Barberà-Llorca, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nuria Templado Peñaranda, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Itziar Rodriguez Adrián, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria Llaberia Marcual, PT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>María del Carmen Blasco-García, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sergio Alonso-Fernández, RN,MSN,PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 3, 2019</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgical wound healing</keyword>
  <keyword>knee arthroplasty</keyword>
  <keyword>postoperative dressings</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_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/NCT04422119
org study id: AC-16-016-CEIMPS
nct id: NCT04422119
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is: to evaluate the efficacy of two post-operative dressings in the
      management of the surgical wounds in patients who received a knee prosthesis
This was a randomised, controlled, clinical trial on patients who received a primary knee
      prosthesis in 2018-2019. Treatment group was given a multi-layer foam dressing with Safetac.
      The control group received standard treatment with povidone-iodine and a gauze dressing with
      plaster. 50 patients was needed for sufficient power. Primary outcome measures were; the
      characteristics of the surgical wound, patient reported comfort and adaptability according to
      the physiotherapist. Secondary outcome measures were: the clinical status and quality of life
      level according to the Western Ontario and McMaster Universities Osteoarthritis Index
      (WOMAC). Statistical analysis was performed by using IBM SPSS version 25, with a statistical
      significance of 5%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in number of dressing changes
time frame: From fist day post-surgery to 7th postoperative day
description: Number of dressing applications to the patients required
measure: Change in patient comfort
time frame: From fist day post-surgery to 7th postoperative day
description: Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)
arm group label: Multi-layer foam dressing
arm group type: Experimental
description: Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound
arm group label: Usual care
arm group type: Active Comparator
description: Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster.
intervention type: Procedure
intervention name: Multi-Foam dressing
description: Application of a multi-layer foam dressing with Safetac in surgical wound
arm group label: Multi-layer foam dressing
intervention type: Procedure
intervention name: Usual care
description: Care of surgical wound with povidone-iodine and a gauze dressing with plaster.
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonia Salmerón-Ramírez, RN
role: Principal Investigator
affiliation: Germans Trias i Pujol University Hospital
last name: Sergio Alonso-Fernández, RN,MSN,PhD
phone: 0034934978437
email: salonso.germanstrias@gencat.cat
last name: Antonia Salmerón-Ramírez, RN
phone: 0034695560386
email: asalmeronr.germanstrias@gencat.cat
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: No