<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/NCT04453319</url>
  </required_header>
  <id_info>
    <org_study_id>RP.19.12.52.R1 - 2020/01/31</org_study_id>
    <nct_id>NCT04453319</nct_id>
  </id_info>
  <brief_title>Efficacy of Negative Pressure Wound Closure Therapy by PICO System in Prevention of Complications of Femoral Artery Exposure</brief_title>
  <official_title>Efficacy of Negative Pressure Wound Closure Therapy by PICO System in Prevention of Complications of Femoral Artery Exposure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      Evaluate negative pressure wound closure therapy by PICO system in Prevention of&#xD;
      complications of femoral artery exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION:&#xD;
&#xD;
      Wound infection is a very common complication in patients who undergo femoral artery&#xD;
      exposure. It can lead to prolonged hospital stays, increased healthcare expenditures,&#xD;
      admission times, graft failure, and limb loss and is recognized as a significant cause of&#xD;
      postoperative morbidity and mortality.&#xD;
&#xD;
      Negative pressure wound therapy (NPWT) has been developped as a method for reducing the risk&#xD;
      of wound complications and is the wound dressing of choice in many vascular procedures during&#xD;
      the arterial exposure.&#xD;
&#xD;
      The idea of NPWT is a therapeutic technique wherein subatmospheric pressure is applied to a&#xD;
      wound using a sealed wound dressing that is connected to a vacuum pump, which can be&#xD;
      continuously or intermittently applied.&#xD;
&#xD;
      The mechanism of NPWT, is that it facilitates wound healing by decreasing the bacterial&#xD;
      burden; promoting granulation tissue formation, capillary blood flow, endothelial&#xD;
      proliferation, and angiogenesis; and restoring the integrity of the capillary basement&#xD;
      membrane.&#xD;
&#xD;
      The clinical efficacy of NPWT for closed incisions has been extensively studied in surgical&#xD;
      disciplines such as orthopedics, cardiothoracic, and plastic surgery, and its use in&#xD;
      promoting wound healing and improving patient outcomes has been validated. The use of&#xD;
      vacuum-assisted closure dressings (PICO system) is currently no evidenced that supports the&#xD;
      use PICO system of for lower limb femoral incisions. Therefore, we aimed to evaluate the&#xD;
      outcomes of PICO system in preventing wound complication in patients with femoral artery&#xD;
      exposure.&#xD;
&#xD;
      Aim of the work Evaluate negative pressure wound closure therapy by PICO system in Prevention&#xD;
      of complications of femoral artery exposure.&#xD;
&#xD;
      Outcome&#xD;
&#xD;
      Primary outcomes:&#xD;
&#xD;
      Infection Hematoma seroma&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
      Wound Dehiscence. Patients and methods Study location: The study will be conducted at the&#xD;
      department of vascular surgery in Mansoura university hospitals Type of study: Randomized&#xD;
      controlled Prospective study Study duration: 2 years: 2019-2021 Sample size: 250 patients&#xD;
      n=(Z^2 p(1-p))/d^2 Where: Z= 1.96 at 95% confidence level, P= expected prevalence, d=&#xD;
      precision (margin of error)&#xD;
&#xD;
      Study population: The study will be conducted in all patients suspected to femoral artery&#xD;
      exposure whatever the type of surgery Inclusion criteria: all patients suspected to femoral&#xD;
      artery exposure whatever the type of surgery Exclusion criteria who can't give consent&#xD;
      (unconscious)? Those with mental or behavioral disorders will be excluded. Consent: Patients&#xD;
      after signing informed consent that possible complication from the procedure ought to happen&#xD;
      and what are the alternatives.&#xD;
&#xD;
      Data collection: The demographics, Symptoms and preoperative clinical data will be collected&#xD;
      History Data: included patient's demographics, underlying medical conditions, any previous&#xD;
      associated morbidity.&#xD;
&#xD;
      Examination: Arterial assessments. Laboratory: Blood picture, Blood sugar level, Kidney&#xD;
      functions, Liver functions and Coagulation profile.&#xD;
&#xD;
      Imaging: Duplex US and CTA Method of Randomization: Block randomization: Two elements A for&#xD;
      Application of the device, B for conventional dressing A A B B A B A B A B B A B B A A B A B&#xD;
      A B A A B Technique After closure of Femoral wound the PICO system is applied for up to 5-7&#xD;
      days. PICO® is a disposable, single-use pump without a canister that generates an effective,&#xD;
      non-adjustable, negative pressure of -80 mmHg and that can be used for up to 7 days.(-1113)&#xD;
      It incorporates leak detection and low battery indicators and is connected to a 4-layer&#xD;
      absorbent dressing that primarily removes wound exudates through evaporative loss. The&#xD;
      mechanism of action has been postulated to occur because of the combined effects of a&#xD;
      reduction in the frequency of dressing changes, a reduction in stress concentration in the&#xD;
      tissue surrounding the incision, and an enhancement in the appositional strength of the&#xD;
      incision line, thus reducing dead space and minimizing the risk of wound contamination.(14)&#xD;
      PICO® has also been demonstrated to enhance lymphatic clearance and decrease the risk of&#xD;
      hematomas or seromas(15) Follow up Every patient will be followed every week till first&#xD;
      month, then every 3 months till 1 years.&#xD;
&#xD;
      Hemodynamic improvement was assessed by ankle brachial pressure index (ABI), performed before&#xD;
      and after the procedure and every 3 months.&#xD;
&#xD;
      Evaluation made to determine wound complications (Infection, Hematoma, seroma and wound&#xD;
      dehiscence)&#xD;
&#xD;
      Statistical analysis The data will be analyzed using Statistical Package for the Social&#xD;
      Sciences. The numerical outcomes e.g. age is calculated as mean. Gender will be recorded as&#xD;
      frequency and percentage. Chi Square test is applied to assess the association of various&#xD;
      parameters. The results will be considered statistically significant if the p-value is found&#xD;
      to be less than or equal to 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 31, 2020</start_date>
  <completion_date type="Anticipated">January 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 30, 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>
    <intervention_model_description>Randomized Comparative study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Block randomization</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Infection</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical( fever, collection) and Radiological</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hematoma</measure>
    <time_frame>12 months</time_frame>
    <description>Blood collected under the suture line</description>
  </primary_outcome>
  <primary_outcome>
    <measure>seroma</measure>
    <time_frame>12 months</time_frame>
    <description>Fluid collected under the suture line</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound Dehiscence</measure>
    <time_frame>12 Months</time_frame>
    <description>a wound ruptures along a surgical incision</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Wound Infection</condition>
  <condition>Wound Surgical</condition>
  <arm_group>
    <arm_group_label>Application of the device (PICO)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PICO® is a disposable, single-use pump without a canister that generates an effective, non-adjustable, negative pressure of -80 mmHg and that can be used for up to 7 days.(-1113) It incorporates leak detection and low battery indicators and is connected to a 4-layer absorbent dressing that primarily removes wound exudates through evaporative loss. The mechanism of action has been postulated to occur because of the combined effects of a reduction in the frequency of dressing changes, a reduction in stress concentration in the tissue surrounding the incision, and an enhancement in the appositional strength of the incision line, thus reducing dead space and minimizing the risk of wound contamination.(14) PICO® has also been demonstrated to enhance lymphatic clearance and decrease the risk of hematomas or seromas</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Dressing of the femoral wound</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional Dressing of the femoral wound</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Femoral Wound Closure and dressing</intervention_name>
    <description>Femoral Wound Closure and dressing</description>
    <arm_group_label>Application of the device (PICO)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All femoral artery exposure whatever the type of surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who can't give consent (unconscious)&#xD;
&#xD;
          -  Those with mental or behavioral disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mosaad A Soliman, P.h.D</last_name>
    <phone>01001535711</phone>
    <phone_ext>002</phone_ext>
    <email>soliman_mosaad@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mansoura</name>
      <address>
        <city>Mansoura</city>
        <state>Mansoura University</state>
        <zip>35111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mansoura UH Hospitals</last_name>
      <phone>0502202876</phone>
      <phone_ext>0200</phone_ext>
      <email>muh@mans.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Mansoura UH Hospitals</last_name>
      <phone>050 2202750</phone>
      <phone_ext>0200</phone_ext>
      <email>muh@mans.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</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>Wound Infection</mesh_term>
    <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/NCT04453319
org study id: RP.19.12.52.R1 - 2020/01/31
nct id: NCT04453319
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluate negative pressure wound closure therapy by PICO system in Prevention of
      complications of femoral artery exposure.
INTRODUCTION:

      Wound infection is a very common complication in patients who undergo femoral artery
      exposure. It can lead to prolonged hospital stays, increased healthcare expenditures,
      admission times, graft failure, and limb loss and is recognized as a significant cause of
      postoperative morbidity and mortality.

      Negative pressure wound therapy (NPWT) has been developped as a method for reducing the risk
      of wound complications and is the wound dressing of choice in many vascular procedures during
      the arterial exposure.

      The idea of NPWT is a therapeutic technique wherein subatmospheric pressure is applied to a
      wound using a sealed wound dressing that is connected to a vacuum pump, which can be
      continuously or intermittently applied.

      The mechanism of NPWT, is that it facilitates wound healing by decreasing the bacterial
      burden; promoting granulation tissue formation, capillary blood flow, endothelial
      proliferation, and angiogenesis; and restoring the integrity of the capillary basement
      membrane.

      The clinical efficacy of NPWT for closed incisions has been extensively studied in surgical
      disciplines such as orthopedics, cardiothoracic, and plastic surgery, and its use in
      promoting wound healing and improving patient outcomes has been validated. The use of
      vacuum-assisted closure dressings (PICO system) is currently no evidenced that supports the
      use PICO system of for lower limb femoral incisions. Therefore, we aimed to evaluate the
      outcomes of PICO system in preventing wound complication in patients with femoral artery
      exposure.

      Aim of the work Evaluate negative pressure wound closure therapy by PICO system in Prevention
      of complications of femoral artery exposure.

      Outcome

      Primary outcomes:

      Infection Hematoma seroma

      Secondary outcomes:

      Wound Dehiscence. Patients and methods Study location: The study will be conducted at the
      department of vascular surgery in Mansoura university hospitals Type of study: Randomized
      controlled Prospective study Study duration: 2 years: 2019-2021 Sample size: 250 patients
      n=(Z^2 p(1-p))/d^2 Where: Z= 1.96 at 95% confidence level, P= expected prevalence, d=
      precision (margin of error)

      Study population: The study will be conducted in all patients suspected to femoral artery
      exposure whatever the type of surgery Inclusion criteria: all patients suspected to femoral
      artery exposure whatever the type of surgery Exclusion criteria who can't give consent
      (unconscious)? Those with mental or behavioral disorders will be excluded. Consent: Patients
      after signing informed consent that possible complication from the procedure ought to happen
      and what are the alternatives.

      Data collection: The demographics, Symptoms and preoperative clinical data will be collected
      History Data: included patient's demographics, underlying medical conditions, any previous
      associated morbidity.

      Examination: Arterial assessments. Laboratory: Blood picture, Blood sugar level, Kidney
      functions, Liver functions and Coagulation profile.

      Imaging: Duplex US and CTA Method of Randomization: Block randomization: Two elements A for
      Application of the device, B for conventional dressing A A B B A B A B A B B A B B A A B A B
      A B A A B Technique After closure of Femoral wound the PICO system is applied for up to 5-7
      days. PICO® is a disposable, single-use pump without a canister that generates an effective,
      non-adjustable, negative pressure of -80 mmHg and that can be used for up to 7 days.(-1113)
      It incorporates leak detection and low battery indicators and is connected to a 4-layer
      absorbent dressing that primarily removes wound exudates through evaporative loss. The
      mechanism of action has been postulated to occur because of the combined effects of a
      reduction in the frequency of dressing changes, a reduction in stress concentration in the
      tissue surrounding the incision, and an enhancement in the appositional strength of the
      incision line, thus reducing dead space and minimizing the risk of wound contamination.(14)
      PICO® has also been demonstrated to enhance lymphatic clearance and decrease the risk of
      hematomas or seromas(15) Follow up Every patient will be followed every week till first
      month, then every 3 months till 1 years.

      Hemodynamic improvement was assessed by ankle brachial pressure index (ABI), performed before
      and after the procedure and every 3 months.

      Evaluation made to determine wound complications (Infection, Hematoma, seroma and wound
      dehiscence)

      Statistical analysis The data will be analyzed using Statistical Package for the Social
      Sciences. The numerical outcomes e.g. age is calculated as mean. Gender will be recorded as
      frequency and percentage. Chi Square test is applied to assess the association of various
      parameters. The results will be considered statistically significant if the p-value is found
      to be less than or equal to 0.05.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Comparative study
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Block randomization
measure: Infection
time frame: 12 months
description: Clinical( fever, collection) and Radiological
measure: Hematoma
time frame: 12 months
description: Blood collected under the suture line
measure: seroma
time frame: 12 months
description: Fluid collected under the suture line
measure: Wound Dehiscence
time frame: 12 Months
description: a wound ruptures along a surgical incision
arm group label: Application of the device (PICO)
arm group type: Experimental
description: PICO® is a disposable, single-use pump without a canister that generates an effective, non-adjustable, negative pressure of -80 mmHg and that can be used for up to 7 days.(-1113) It incorporates leak detection and low battery indicators and is connected to a 4-layer absorbent dressing that primarily removes wound exudates through evaporative loss. The mechanism of action has been postulated to occur because of the combined effects of a reduction in the frequency of dressing changes, a reduction in stress concentration in the tissue surrounding the incision, and an enhancement in the appositional strength of the incision line, thus reducing dead space and minimizing the risk of wound contamination.(14) PICO® has also been demonstrated to enhance lymphatic clearance and decrease the risk of hematomas or seromas
arm group label: Conventional Dressing of the femoral wound
arm group type: No Intervention
description: Conventional Dressing of the femoral wound
intervention type: Procedure
intervention name: Femoral Wound Closure and dressing
description: Femoral Wound Closure and dressing
arm group label: Application of the device (PICO)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mosaad A Soliman, P.h.D
phone: 01001535711
phone ext: 002
email: soliman_mosaad@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Sponsor
mesh term: Wound Infection
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: No