<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/NCT01700595</url>
  </required_header>
  <id_info>
    <org_study_id>hocaoglupediatricperforator1</org_study_id>
    <secondary_id>emrehocaoglu</secondary_id>
    <nct_id>NCT01700595</nct_id>
  </id_info>
  <brief_title>Preexpanded Perforator Flaps in Children</brief_title>
  <official_title>Preexpanded Perforator Flaps in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Contractures and broad scars of the axilla, anterior chest wall and neck have detrimental&#xD;
      effects on functional, physical and psychological development of children. Perforator flaps&#xD;
      have already been shown to be reliable options for the reconstruction of contractures but&#xD;
      there have been no reports demonstrating the value of preexpanded perforator flaps of&#xD;
      dorsolateral trunk region in treatment of extensive contractures and scars of pediatric&#xD;
      patients. The purpose of this study is to demonstrate these techniques by a case series&#xD;
      formed of pediatric patients with broad scars and contractures of anterior chest wall,&#xD;
      axilla, neck and breasts. Seven pediatric patients (mean age, 11,6 years) who were treated by&#xD;
      preexpanded perforator flaps are presented. By this means, clinical experience on intercostal&#xD;
      artery perforator (ICAP) flap, thoracodorsal artery perforator (TDAP) flap, circumflex&#xD;
      scapular artery perforator (CSAP) flap and lumbar artery perforator flap was shared. Flaps as&#xD;
      large as 20,5x10,5 cm in size could be successfully transferred in pediatric patients. Broad&#xD;
      scar tissues were resurfaced with broad flaps carrying similar characteristics with the&#xD;
      uninjured anterior chest wall and neck skin in six of our patients. In one patient with&#xD;
      partial necrosis, full thickness skin graft was used for the residual defect. The mean&#xD;
      duration of postoperative (after flap transfer) follow-ups was 17,2 months. The preexpanded&#xD;
      TDAP, ICAP and CSAP flaps are revealed to be useful reconstructive options for the treatment&#xD;
      of scars and contractures of anterior chest wall, axilla, neck and breast in pediatric&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Range of motion of the particular joint</measure>
    <time_frame>at least three months after flap tarnsfer</time_frame>
    <description>Disruption of the contracture band and releasing the contracture of a particular joint results in achievement of the healthy range of motion of that joint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Replaced tissue dimensions</measure>
    <time_frame>at least three months after the operation</time_frame>
    <description>Transferred flap sizes will be documented. It is a way of demonstrating the amount of replaced scar tissue and exhibiting the success of the technique.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Developement of related anatomic structures</measure>
    <time_frame>at least a year after flap transfer</time_frame>
    <description>Resurfacing the broad scar tissue and releasing the contracture leads to normal developement of the relevant extremity, chest, neck, breast and posture of the patient, thus, providing the healthy developement of the child.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Contractures</condition>
  <condition>Scars</condition>
  <arm_group>
    <arm_group_label>new technical intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>''new technical intervention'' represents the surgical procedure which is applied for the patients assigned to this group because of their certain characteristics. Namely, pediatric patients with broad axillary, anterior chest wall, mammary and neck scars are treated with this surgical approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>new technical intervention</intervention_name>
    <description>Contractures and broad scars of the subjects are treated by this surgical intervention which is a reconstructive surgery that is performed by the transfer of preexpanded perforator flaps to the recipient sites of skin deficiency.</description>
    <arm_group_label>new technical intervention</arm_group_label>
    <other_name>reconstructive surgery by transfer of preexpanded perforator flaps</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric age group&#xD;
&#xD;
          -  broad scars and contractures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
          -  minimal scars and skin defects that could be treated by minor interventions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul University, Istanbul Faculty of Medicine</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Emre Hocaoglu</investigator_full_name>
    <investigator_title>Specialist, M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contracture</mesh_term>
  </condition_browse>
  <!-- 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/NCT01700595
org study id: hocaoglupediatricperforator1
secondary id: emrehocaoglu
nct id: NCT01700595
lead sponsor: 
has dmc: No
Contractures and broad scars of the axilla, anterior chest wall and neck have detrimental
      effects on functional, physical and psychological development of children. Perforator flaps
      have already been shown to be reliable options for the reconstruction of contractures but
      there have been no reports demonstrating the value of preexpanded perforator flaps of
      dorsolateral trunk region in treatment of extensive contractures and scars of pediatric
      patients. The purpose of this study is to demonstrate these techniques by a case series
      formed of pediatric patients with broad scars and contractures of anterior chest wall,
      axilla, neck and breasts. Seven pediatric patients (mean age, 11,6 years) who were treated by
      preexpanded perforator flaps are presented. By this means, clinical experience on intercostal
      artery perforator (ICAP) flap, thoracodorsal artery perforator (TDAP) flap, circumflex
      scapular artery perforator (CSAP) flap and lumbar artery perforator flap was shared. Flaps as
      large as 20,5x10,5 cm in size could be successfully transferred in pediatric patients. Broad
      scar tissues were resurfaced with broad flaps carrying similar characteristics with the
      uninjured anterior chest wall and neck skin in six of our patients. In one patient with
      partial necrosis, full thickness skin graft was used for the residual defect. The mean
      duration of postoperative (after flap transfer) follow-ups was 17,2 months. The preexpanded
      TDAP, ICAP and CSAP flaps are revealed to be useful reconstructive options for the treatment
      of scars and contractures of anterior chest wall, axilla, neck and breast in pediatric
      patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Range of motion of the particular joint
time frame: at least three months after flap tarnsfer
description: Disruption of the contracture band and releasing the contracture of a particular joint results in achievement of the healthy range of motion of that joint.
measure: Replaced tissue dimensions
time frame: at least three months after the operation
description: Transferred flap sizes will be documented. It is a way of demonstrating the amount of replaced scar tissue and exhibiting the success of the technique.
measure: Developement of related anatomic structures
time frame: at least a year after flap transfer
description: Resurfacing the broad scar tissue and releasing the contracture leads to normal developement of the relevant extremity, chest, neck, breast and posture of the patient, thus, providing the healthy developement of the child.
arm group label: new technical intervention
arm group type: Experimental
description: ''new technical intervention'' represents the surgical procedure which is applied for the patients assigned to this group because of their certain characteristics. Namely, pediatric patients with broad axillary, anterior chest wall, mammary and neck scars are treated with this surgical approach.
intervention type: Procedure
intervention name: new technical intervention
description: Contractures and broad scars of the subjects are treated by this surgical intervention which is a reconstructive surgery that is performed by the transfer of preexpanded perforator flaps to the recipient sites of skin deficiency.
arm group label: new technical intervention
other name: reconstructive surgery by transfer of preexpanded perforator flaps
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Emre Hocaoglu
investigator title: Specialist, M.D.
mesh term: Contracture