<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/NCT03791710</url>
  </required_header>
  <id_info>
    <org_study_id>AbouqirBurn1</org_study_id>
    <nct_id>NCT03791710</nct_id>
  </id_info>
  <brief_title>Effect of Autologous Fat Grafting on Acute Burn Wound Healing</brief_title>
  <official_title>Effect of Autologous Fat Grafting and Nanofat Usage on Burn Wound Healing and Early Scarring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmed Mohamed Abouzaid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abouqir General 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 study evaluates the role of autologous fat grafting and the usage of nanofat in the&#xD;
      treatment of the acute burn injuries in different genders and its influences on the healing&#xD;
      time and hospital stay, pain control, the need and take of a split thickness skin graft and&#xD;
      its size, and the end resulting early scarring, in comparison with control group that were&#xD;
      treated with traditional methods, so as to find out new method of treating burn injuries and&#xD;
      decreasing its morbidity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      as the patient is admitted, full evaluation locally ( as regard the wound itself and the&#xD;
      areas of fat harvesting) and generally (assessment of the general condition) is done, fluid&#xD;
      resuscitation is started as the unit protocol hand in hand with the analgesia and other&#xD;
      medications prescribed according to the unit protocol.&#xD;
&#xD;
      the patient's general condition is optimized for surgery of the fat extraction and grafting&#xD;
      which typically should be within the first 6 days of admission.&#xD;
&#xD;
      then under anesthesia (any possible type from local and regional up to general anesthesia)&#xD;
      liposuction procedure is performed, then fat is processed then grafted at the wound site with&#xD;
      other portion prepared as nanofat for topical use and wound coverage, then sterile dressing&#xD;
      is applied.&#xD;
&#xD;
      typically follow up is held daily with the dressing change day after another with the use of&#xD;
      the nanofat only and sterile dressing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>Phase 3</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>two groups one will have the fat grafting and the other will be the control group treated with the conventional methods</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>wound healing time</measure>
    <time_frame>one to three weeks</time_frame>
    <description>the effect of the fat grafting on the wound healing time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>effect on pain perception, subjective assessment scale</measure>
    <time_frame>immediate post-operative and up to three weeks</time_frame>
    <description>effect of the fat grafting on the pain sensation in the burn wound, assessment through a numerical scale starting at &quot;0&quot; indicating no pain at all to &quot;10&quot; the most intense severe pain. the range between &quot;1&quot; and &quot;3&quot; describes mild pain, between &quot;4&quot; and &quot;6&quot; describes moderate pain, and lastly from &quot;7&quot; to &quot;10&quot; severe pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fat grafting group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group of patients will have the autologous fat grafting for their burn wounds</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>autologous fat grafting</intervention_name>
    <description>regular liposuction procedure at which sufficient amount of fat is extracted from the patient and then the fat is processed then grafted underneath the burn wound</description>
    <arm_group_label>fat grafting group</arm_group_label>
    <other_name>liposuction and lipofilling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Cream</intervention_name>
    <description>serial dressing with topical agents e.g Silver Sulphadiazine</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>dressing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>split thickness skin grafting</intervention_name>
    <description>depridment and split thickness skin grafting</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>fat grafting group</arm_group_label>
    <other_name>skin grafting</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  both males and females within the age frame are candidates.&#xD;
&#xD;
          -  previously healthy individuals with no co-morbid conditions e.g cardiac, hepatic,&#xD;
             diabetic, vascular or renal disease.&#xD;
&#xD;
          -  with TBSA of 10 to 30% affected and of deep dermal to full thickness wound depth, at&#xD;
             any part of the body except the genitalia, perineum or the perianal region or those&#xD;
             with inhalational injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other patients aged younger or older than the specified age group.&#xD;
&#xD;
          -  patients with co-morbid conditions.&#xD;
&#xD;
          -  patients with smaller or larger BSA than the specified BSA.&#xD;
&#xD;
          -  burns involving the genitalia, perineum or the perianal region and patients with&#xD;
             inhalational injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed M Abouzaid, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abouqir GH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abouqir General Hospital</name>
      <address>
        <city>Alexandria</city>
        <zip>21527</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Abouqir General Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abouzaid</investigator_full_name>
    <investigator_title>specialist plastic, reconstructive surgery and burn therapy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</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/NCT03791710
org study id: AbouqirBurn1
nct id: NCT03791710
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the study evaluates the role of autologous fat grafting and the usage of nanofat in the
      treatment of the acute burn injuries in different genders and its influences on the healing
      time and hospital stay, pain control, the need and take of a split thickness skin graft and
      its size, and the end resulting early scarring, in comparison with control group that were
      treated with traditional methods, so as to find out new method of treating burn injuries and
      decreasing its morbidity.
as the patient is admitted, full evaluation locally ( as regard the wound itself and the
      areas of fat harvesting) and generally (assessment of the general condition) is done, fluid
      resuscitation is started as the unit protocol hand in hand with the analgesia and other
      medications prescribed according to the unit protocol.

      the patient's general condition is optimized for surgery of the fat extraction and grafting
      which typically should be within the first 6 days of admission.

      then under anesthesia (any possible type from local and regional up to general anesthesia)
      liposuction procedure is performed, then fat is processed then grafted at the wound site with
      other portion prepared as nanofat for topical use and wound coverage, then sterile dressing
      is applied.

      typically follow up is held daily with the dressing change day after another with the use of
      the nanofat only and sterile dressing
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: two groups one will have the fat grafting and the other will be the control group treated with the conventional methods
primary purpose: Treatment
masking: None (Open Label)
measure: wound healing time
time frame: one to three weeks
description: the effect of the fat grafting on the wound healing time
measure: effect on pain perception, subjective assessment scale
time frame: immediate post-operative and up to three weeks
description: effect of the fat grafting on the pain sensation in the burn wound, assessment through a numerical scale starting at "0" indicating no pain at all to "10" the most intense severe pain. the range between "1" and "3" describes mild pain, between "4" and "6" describes moderate pain, and lastly from "7" to "10" severe pain.
arm group label: control group
arm group type: Placebo Comparator
description: this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine
arm group label: fat grafting group
arm group type: Active Comparator
description: this group of patients will have the autologous fat grafting for their burn wounds
intervention type: Procedure
intervention name: autologous fat grafting
description: regular liposuction procedure at which sufficient amount of fat is extracted from the patient and then the fat is processed then grafted underneath the burn wound
arm group label: fat grafting group
other name: liposuction and lipofilling
intervention type: Drug
intervention name: Topical Cream
description: serial dressing with topical agents e.g Silver Sulphadiazine
arm group label: control group
other name: dressing
intervention type: Procedure
intervention name: split thickness skin grafting
description: depridment and split thickness skin grafting
arm group label: control group
arm group label: fat grafting group
other name: skin grafting
criteria: 
gender: All
minimum age: 13 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ahmed M Abouzaid, MSc
role: Principal Investigator
affiliation: Abouqir GH
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Abouqir General Hospital
investigator full name: Ahmed Mohamed Abouzaid
investigator title: specialist plastic, reconstructive surgery and burn therapy
mesh term: Burns
sharing ipd: Undecided