xml: <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/NCT05996614</url>
    </required_header>
    <id_info>
      <org_study_id>PRP in skin grafts</org_study_id>
      <nct_id>NCT05996614</nct_id>
    </id_info>
    <brief_title>Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas</brief_title>
    <official_title>Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. To evaluate the effect of the platelet rich plasma on the take of split thickness skin&#xD;
             graft and its early and late results in resurfacing of post burn raw areas.&#xD;
  &#xD;
          2. To evaluate the effect of PRP on wound healing on skin graft donor site.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Burn injuries involve tissue destruction due to energy transfer,The burn injuries can be&#xD;
        caused by heat from hot liquids, solids or fire, an less common causes are friction, heat,&#xD;
        chemical or electric sources The treatment of burns is complex due to the combination of&#xD;
        hypermetabolic physiological response and the need for good functional and cosmetic recovery.&#xD;
        Split thickness skin grafts (STSGs) are commonly used to resurface large areas of Post burn&#xD;
        raw areas.&#xD;
  &#xD;
        The time to complete wound healing ranged from 2 to 75 days. Factors that significantly&#xD;
        affected time to complete wound healing were graft loss by seroma, presence of&#xD;
        hypergranulation tissue, premorbid conditions, and total body surface area burned.&#xD;
  &#xD;
        Generally, skin graft undertakes three steps for healing: anchorage, inosculation, and&#xD;
        maturation. Haematoma, shearing, and infection on recipient sites of skin graft can reduce&#xD;
        skin graft take, and even lead to skin graft loss.&#xD;
  &#xD;
        Platelet-rich plasma (PRP) is an autologous blood-derived biomaterial that is enriched with a&#xD;
        2- to 6-fold concentration of platelets in comparison to normal human platelet concentration.&#xD;
        Multiple growth factors and bioactive proteins are stored in α-granules of platelets. These&#xD;
        growth factors can promote proliferation of endothelial cells, epithelial cells as well as&#xD;
        fibroblasts, and increase angiogenesis. The potential clinical application of PRP in skin&#xD;
        graft might rely on its haemostasis, adhesive, antibacterial and healing properties.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>histopathological biopsy from both groups by punch Biopsy (vancouver scale )</measure>
      <time_frame>3 months</time_frame>
      <description>pigmentation (0-2) ,normal 0, Hypopigmentation 1 ,Hyperpigmentation 2 Vascularity (0-3) ,Normal 0, Pink 1, Red 2, Purple 3 Pliability (0-5) Normal 0 ,Supple 1 ,Yielding 2,Firm 3, Banding 4, Contracture 5 Height (0-3) Normal(flat)0 ,(0-2mm)1,(2-5mm)2,(&gt;5mm)3</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Skin Burn</condition>
    <arm_group>
      <arm_group_label>group with PRP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of patients with post burn raw areas treated with application of platelet rich plasma</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group without PRP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of patients with post burn raw areas treated with conventional methods</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PRP in skin grafts</intervention_name>
      <description>topical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas</description>
      <arm_group_label>group with PRP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>conventional methods in skin grafts</intervention_name>
      <description>fixation of the graft with stitches and staplers</description>
      <arm_group_label>group without PRP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age (15- 60 years).&#xD;
  &#xD;
            2. Post burn Raw area less than 10 % of total body surface area .&#xD;
  &#xD;
            3. Selected donor sites.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Raw area due to other causes ( trauma, ischemia,..etc)&#xD;
  &#xD;
            2. Patients with bleeding tendency.&#xD;
  &#xD;
            3. Patients with comorbidities(diabetes, malignancy,..etc)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mostafa Elsonbaty, prof</last_name>
      <role>Study Chair</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ibrahim Ragab Ibrahim, master</last_name>
      <phone>00201060865454</phone>
      <email>himo_nimo9@icloud.com</email>
    </overall_contact>
    <results_reference>
      <citation>Garcia-Sanchez JM, Mirabet Lis V, Ruiz-Valls A, Perez-Plaza A, Sepulveda Sanchis P, Perez-Del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clinical trial. Burns. 2022 Nov;48(7):1662-1670. doi: 10.1016/j.burns.2021.10.001. Epub 2021 Oct 22.</citation>
      <PMID>34952738</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>October 7, 2022</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Ibrahim Ragab Ibrahim ali</investigator_full_name>
      <investigator_title>principal investigator</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996614
  org study id: PRP in skin grafts
  nct id: NCT05996614
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  1. To evaluate the effect of the platelet rich plasma on the take of split thickness skin
             graft and its early and late results in resurfacing of post burn raw areas.
  
          2. To evaluate the effect of PRP on wound healing on skin graft donor site.
  Burn injuries involve tissue destruction due to energy transfer,The burn injuries can be
        caused by heat from hot liquids, solids or fire, an less common causes are friction, heat,
        chemical or electric sources The treatment of burns is complex due to the combination of
        hypermetabolic physiological response and the need for good functional and cosmetic recovery.
        Split thickness skin grafts (STSGs) are commonly used to resurface large areas of Post burn
        raw areas.
  
        The time to complete wound healing ranged from 2 to 75 days. Factors that significantly
        affected time to complete wound healing were graft loss by seroma, presence of
        hypergranulation tissue, premorbid conditions, and total body surface area burned.
  
        Generally, skin graft undertakes three steps for healing: anchorage, inosculation, and
        maturation. Haematoma, shearing, and infection on recipient sites of skin graft can reduce
        skin graft take, and even lead to skin graft loss.
  
        Platelet-rich plasma (PRP) is an autologous blood-derived biomaterial that is enriched with a
        2- to 6-fold concentration of platelets in comparison to normal human platelet concentration.
        Multiple growth factors and bioactive proteins are stored in α-granules of platelets. These
        growth factors can promote proliferation of endothelial cells, epithelial cells as well as
        fibroblasts, and increase angiogenesis. The potential clinical application of PRP in skin
        graft might rely on its haemostasis, adhesive, antibacterial and healing properties.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: histopathological biopsy from both groups by punch Biopsy (vancouver scale )
  time frame: 3 months
  description: pigmentation (0-2) ,normal 0, Hypopigmentation 1 ,Hyperpigmentation 2 Vascularity (0-3) ,Normal 0, Pink 1, Red 2, Purple 3 Pliability (0-5) Normal 0 ,Supple 1 ,Yielding 2,Firm 3, Banding 4, Contracture 5 Height (0-3) Normal(flat)0 ,(0-2mm)1,(2-5mm)2,(>5mm)3
  arm group label: group with PRP
  arm group type: Experimental
  description: Group of patients with post burn raw areas treated with application of platelet rich plasma
  arm group label: group without PRP
  arm group type: Experimental
  description: Group of patients with post burn raw areas treated with conventional methods
  intervention type: Procedure
  intervention name: PRP in skin grafts
  description: topical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas
  arm group label: group with PRP
  intervention type: Procedure
  intervention name: conventional methods in skin grafts
  description: fixation of the graft with stitches and staplers
  arm group label: group without PRP
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mostafa Elsonbaty, prof
  role: Study Chair
  affiliation: Assiut University
  last name: Ibrahim Ragab Ibrahim, master
  phone: 00201060865454
  email: himo_nimo9@icloud.com
  citation: Garcia-Sanchez JM, Mirabet Lis V, Ruiz-Valls A, Perez-Plaza A, Sepulveda Sanchis P, Perez-Del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clinical trial. Burns. 2022 Nov;48(7):1662-1670. doi: 10.1016/j.burns.2021.10.001. Epub 2021 Oct 22.
  PMID: 34952738
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Ibrahim Ragab Ibrahim ali
  investigator title: principal investigator
  mesh term: Burns
  sharing ipd: No