<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/NCT03788239</url>
  </required_header>
  <id_info>
    <org_study_id>IRD_IRB_2017_06_006</org_study_id>
    <nct_id>NCT03788239</nct_id>
  </id_info>
  <brief_title>Wound Closure After Total Knee Replacement</brief_title>
  <official_title>Wound Closure After Total Knee Replacement: Comparison Between Staples and Sutures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indus Hospital and Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indus Hospital and Health Network</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To compare the wound healing after total knee replacement wound closure with staples versus&#xD;
      subcuticular prolene suture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      .Informed consent will be taken from all the patients who meet the inclusion and exclusion&#xD;
      criteria and then will be randomized into one of the two study arms (Arm 1: will undergo&#xD;
      wound closure with staples and Arm 2 wound closure with subcuticular prolene suture).&#xD;
&#xD;
      before the start of surgery. The primary investigator will open the sealed envelopes provided&#xD;
      by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study&#xD;
      arm allocation. The envelopes will follow the SNOSE protocol i.e. they will be sequentially&#xD;
      numbered, opaque sealed envelopes. Before opening the envelope, the primary investigator will&#xD;
      write the patient's medical record number, date and will sign the envelope. The envelope will&#xD;
      contain carbon paper which will transfer the data allocation paper inside.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound healing</measure>
    <time_frame>Surgery till 1 year post-op</time_frame>
    <description>Wound healing will be assessed using Hollander Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>Surgery till 1 year post-op</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">211</enrollment>
  <condition>Wound of Knee</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Right knee wound closure by staples and Left Knee wound closure by sutures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Right knee wound closure by sutures and Left Knee wound closure by staples</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Staples versus sutures</intervention_name>
    <description>Prolene suture: non-absorbable, sterile surgical suture composed of an isotactic crystalline steroisomer of polypropylene, a synthetic linear polyolefin. After completion of the procedure, deep tissues will closed with subcuticular prolene suture. Compared to the absorbable sutures, prolene is known to cause less infection since it is a monofilament material.&#xD;
Staples: specialized staples used in surgery in place of sutures to close skin wounds. After completion of the procedure, deep tissues were closed with absorbable braided suture, then the skin will be closed by staples.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing primary total knee replacements for osteoarthritis or&#xD;
             post-traumatic arthritis (diagnosed on X-rays and history)&#xD;
&#xD;
          -  Bilateral knee surgeries&#xD;
&#xD;
          -  Patients giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having previous skin, neuromuscular or connective tissue disorder (confirmed&#xD;
             by history)&#xD;
&#xD;
          -  Patients taking steroids (confirmed by history)&#xD;
&#xD;
          -  Body mass index &gt; 30 (increases chances of wound dehiscence)&#xD;
&#xD;
          -  Lack of consent&#xD;
&#xD;
          -  Pregnant females (confirmed by history)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Indus Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>75100</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Waseem Memon</last_name>
      <phone>03313334112</phone>
      <email>dr.waseemmemon@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>December 24, 2018</last_update_submitted>
  <last_update_submitted_qc>December 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</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>Wounds and Injuries</mesh_term>
  </condition_browse>
  <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/NCT03788239
org study id: IRD_IRB_2017_06_006
nct id: NCT03788239
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the wound healing after total knee replacement wound closure with staples versus
      subcuticular prolene suture.
.Informed consent will be taken from all the patients who meet the inclusion and exclusion
      criteria and then will be randomized into one of the two study arms (Arm 1: will undergo
      wound closure with staples and Arm 2 wound closure with subcuticular prolene suture).

      before the start of surgery. The primary investigator will open the sealed envelopes provided
      by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study
      arm allocation. The envelopes will follow the SNOSE protocol i.e. they will be sequentially
      numbered, opaque sealed envelopes. Before opening the envelope, the primary investigator will
      write the patient's medical record number, date and will sign the envelope. The envelope will
      contain carbon paper which will transfer the data allocation paper inside.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Wound healing
time frame: Surgery till 1 year post-op
description: Wound healing will be assessed using Hollander Score
measure: Complications
time frame: Surgery till 1 year post-op
arm group label: Arm 1
arm group type: Experimental
description: Right knee wound closure by staples and Left Knee wound closure by sutures
arm group label: Arm 2
arm group type: Experimental
description: Right knee wound closure by sutures and Left Knee wound closure by staples
intervention type: Other
intervention name: Staples versus sutures
description: Prolene suture: non-absorbable, sterile surgical suture composed of an isotactic crystalline steroisomer of polypropylene, a synthetic linear polyolefin. After completion of the procedure, deep tissues will closed with subcuticular prolene suture. Compared to the absorbable sutures, prolene is known to cause less infection since it is a monofilament material.
Staples: specialized staples used in surgery in place of sutures to close skin wounds. After completion of the procedure, deep tissues were closed with absorbable braided suture, then the skin will be closed by staples.
arm group label: Arm 1
arm group label: Arm 2
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Pakistan
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: Undecided