<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/NCT03269864</url>
  </required_header>
  <id_info>
    <org_study_id>17200122</org_study_id>
    <nct_id>NCT03269864</nct_id>
  </id_info>
  <brief_title>Use of Perforator Flaps for Leg and Foot Reconstruction</brief_title>
  <official_title>Use of Perforator Flaps for Leg and Foot Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Perforator vessels are those where the source artery is deep and the branch that carries&#xD;
      blood to the fasciocutaneous tissues passes through the overlying deep fascia.&#xD;
&#xD;
      Soft tissue defects in the lower extremity, especially distal third of leg, present a&#xD;
      challenge to reconstructive surgeons due to lack of reliable local flaps, conventional&#xD;
      reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross&#xD;
      leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free&#xD;
      tissue transfer. All these procedures have their limitations and associated morbidity at&#xD;
      donor site&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Taylor and Palmer defined an angiosome as a three-dimensional vascular territory supplied by&#xD;
      a source artery and vein through branches for all tissue layers between the skin and the&#xD;
      bone, and showed that between neighboring angiosomes there are choked and true anastomotic&#xD;
      arteries.&#xD;
&#xD;
      Koshima and Soeda in 1989, described an inferior epigastric artery skin flap without the&#xD;
      rectus abdominis muscle for reconstruction of floor of mouth, began the era of perforator&#xD;
      flaps.&#xD;
&#xD;
      The big popularity gained by the local perforator flaps was due to their main advantages: 1)&#xD;
      Sparing of the source artery and underlying muscle and fascia, 2) Combining the very good&#xD;
      blood supply of a musculocutaneous flap with the reduced donor-site morbidity of a skin flap,&#xD;
      3) Replacing like with like, 4) Limiting the donor-site to the same area, 5) Possibility of&#xD;
      completely or partially primarily closure, 6) Technically less demanding, because they are&#xD;
      microsurgical procedures, but without microvascular sutures, 7) Shorter operating time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 5, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>two arms, one will be managed by pedicled perforator flaps the other will be managed by free perforator flaps</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the perforator flap</measure>
    <time_frame>This will be assessed in the first week postoperative</time_frame>
    <description>The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Post Traumatic Skin Defect in Leg and Foot</condition>
  <arm_group>
    <arm_group_label>pedicled perforator flaps</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Once the perforator is identified, the flap will be designed around the perforator or perforators according to the location and size of the defect.&#xD;
A tourniquet is inflated without prior exsanguination. This maneuver facilitates identification of perforators as they remain filled with the blood.&#xD;
An exploratory incision along the margin of flap is made keeping the position of marked perforator in mind. The incision is made through the skin, subcutaneous tissue, deep fascia (sub-fascial approach) and the perforator vessel is directly visualized. The incision is initially always made from one side of the flap only to properly identify the perforator.&#xD;
Careful and meticulous dissection is done in a blunt way isolating the perforator.&#xD;
After deflation of the tourniquet, hemostasis is performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>free perforator flaps</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A two-team approach is used for microvascular free tissue transfer. The first team starts exploring the limb for the recipient vessel. The second team simultaneously begins elevating the perforator flap and its vascular pedicle.&#xD;
Microvascular anastomosis will be carried out under operating microscope for one artery and one or two accompanying veins.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>perforator flaps</intervention_name>
    <description>40 patients with post traumatic skin defect at leg and foot will be managed by perforator flaps, 20 with pedicled perforator flaps and other 20 with free perforator flaps</description>
    <arm_group_label>free perforator flaps</arm_group_label>
    <arm_group_label>pedicled perforator flaps</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Traumatic soft tissue defects on foot and leg.&#xD;
&#xD;
          2. Simple defects i.e., soft tissue loss, with or without, tendon injury.&#xD;
&#xD;
          3. Patients from 6 years to 60 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other causes of soft tissue defects e.g. (Diabetic, Vascular, post malignant&#xD;
             resection).&#xD;
&#xD;
          2. Complex defects (soft tissue with bone injury).&#xD;
&#xD;
          3. Patients below 6 years or above 60 years old.&#xD;
&#xD;
          4. Patients with debilitating diseases e.g chronic renal failure, diabetes mellitus….etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Youssef Saleh Hassan, prof</last_name>
    <phone>01001166118</phone>
    <phone_ext>002</phone_ext>
    <email>plasticclinic66@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Kamal Osman, Dr</last_name>
    <phone>01060118001</phone>
    <phone_ext>002</phone_ext>
    <email>ahmedkamal@aun.edu.eg</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Adel</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <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/NCT03269864
org study id: 17200122
nct id: NCT03269864
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Perforator vessels are those where the source artery is deep and the branch that carries
      blood to the fasciocutaneous tissues passes through the overlying deep fascia.

      Soft tissue defects in the lower extremity, especially distal third of leg, present a
      challenge to reconstructive surgeons due to lack of reliable local flaps, conventional
      reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross
      leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free
      tissue transfer. All these procedures have their limitations and associated morbidity at
      donor site
Taylor and Palmer defined an angiosome as a three-dimensional vascular territory supplied by
      a source artery and vein through branches for all tissue layers between the skin and the
      bone, and showed that between neighboring angiosomes there are choked and true anastomotic
      arteries.

      Koshima and Soeda in 1989, described an inferior epigastric artery skin flap without the
      rectus abdominis muscle for reconstruction of floor of mouth, began the era of perforator
      flaps.

      The big popularity gained by the local perforator flaps was due to their main advantages: 1)
      Sparing of the source artery and underlying muscle and fascia, 2) Combining the very good
      blood supply of a musculocutaneous flap with the reduced donor-site morbidity of a skin flap,
      3) Replacing like with like, 4) Limiting the donor-site to the same area, 5) Possibility of
      completely or partially primarily closure, 6) Technically less demanding, because they are
      microsurgical procedures, but without microvascular sutures, 7) Shorter operating time.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: two arms, one will be managed by pedicled perforator flaps the other will be managed by free perforator flaps
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of the perforator flap
time frame: This will be assessed in the first week postoperative
description: The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering).
arm group label: pedicled perforator flaps
arm group type: Active Comparator
description: Once the perforator is identified, the flap will be designed around the perforator or perforators according to the location and size of the defect.
A tourniquet is inflated without prior exsanguination. This maneuver facilitates identification of perforators as they remain filled with the blood.
An exploratory incision along the margin of flap is made keeping the position of marked perforator in mind. The incision is made through the skin, subcutaneous tissue, deep fascia (sub-fascial approach) and the perforator vessel is directly visualized. The incision is initially always made from one side of the flap only to properly identify the perforator.
Careful and meticulous dissection is done in a blunt way isolating the perforator.
After deflation of the tourniquet, hemostasis is performed.
arm group label: free perforator flaps
arm group type: Active Comparator
description: A two-team approach is used for microvascular free tissue transfer. The first team starts exploring the limb for the recipient vessel. The second team simultaneously begins elevating the perforator flap and its vascular pedicle.
Microvascular anastomosis will be carried out under operating microscope for one artery and one or two accompanying veins.
intervention type: Procedure
intervention name: perforator flaps
description: 40 patients with post traumatic skin defect at leg and foot will be managed by perforator flaps, 20 with pedicled perforator flaps and other 20 with free perforator flaps
arm group label: free perforator flaps
arm group label: pedicled perforator flaps
criteria: 
gender: All
minimum age: 6 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Youssef Saleh Hassan, prof
phone: 01001166118
phone ext: 002
email: plasticclinic66@gmail.com
last name: Ahmed Kamal Osman, Dr
phone: 01060118001
phone ext: 002
email: ahmedkamal@aun.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Adel
investigator title: Principal investigator
sharing ipd: No