<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/NCT03781882</url>
  </required_header>
  <id_info>
    <org_study_id>PRP surgical wounds</org_study_id>
    <nct_id>NCT03781882</nct_id>
  </id_info>
  <brief_title>Local Injection of PRP During Repair of Disrupted Surgical Wounds</brief_title>
  <official_title>Local Injection of Autologous Platelet Rich Plasma During Repair of Disrupted Surgical Wounds at Obstetrics and Gynecology Department: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta 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>
      Patients with disrupted wounds will either managed as usual or managed by Platelet rich&#xD;
      plasma local infiltration in the wound edges&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with disrupted surgical wounds will be cleansed, debrided and closed with&#xD;
      infiltration of platelet rich plasma in one group and the other group will be closed without&#xD;
      infiltration of Platelet rich plasma&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>All cases with disrupted surgical wounds admitted at Obstetrics and Gynecology departments</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients were not allowed to know allocations</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Complete wound healing</measure>
    <time_frame>30 days</time_frame>
    <description>time needed for complete wound closure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>Time during which patient is admitted</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure of complete wound healing</measure>
    <time_frame>30 days</time_frame>
    <description>No complete closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need fo tertiary suture</measure>
    <time_frame>30 days</time_frame>
    <description>need to re-operate the case again</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Role of Platelet Rich Plasma in Wound Healing</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients in this group will be manged as usual with infiltration of platelet rich plasma in thee wound edges during closure of the wounds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients in this group will be managed by repair of wounds without infiltration of platelet rich plasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Platelet rich plasma infiltration in the wound edges</intervention_name>
    <description>platelet rich plasma will be injected in the wound edges</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Closure of wound without platelet rich plasma infiltration</intervention_name>
    <description>No infiltration of platelet rich plasma is done</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Disrupted surgical wounds after cesarean sections and other gynecological operations&#xD;
&#xD;
          -  Body mass index 18-25&#xD;
&#xD;
          -  Hemoglobin &gt; 10.5gm/dl&#xD;
&#xD;
          -  Albumin &gt;3.5gm/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical disorders asDiabetes mellitus (DM), Liver disease or systemic lupus&#xD;
             erythymatosus (SLE)&#xD;
&#xD;
          -  Patient on corticosteriod therapy&#xD;
&#xD;
          -  Thrombocytopenia&#xD;
&#xD;
          -  Coagulation disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ayman Shehata Dawood</name>
      <address>
        <city>Tanta</city>
        <zip>31111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Ayman S Dawood, MD</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Platelet rich plasma</keyword>
  <keyword>disrupted wounds</keyword>
  <keyword>Obstetrics and Gynecology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will share unidentified data</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>30 days</ipd_time_frame>
  </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/NCT03781882
org study id: PRP surgical wounds
nct id: NCT03781882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with disrupted wounds will either managed as usual or managed by Platelet rich
      plasma local infiltration in the wound edges
The patients with disrupted surgical wounds will be cleansed, debrided and closed with
      infiltration of platelet rich plasma in one group and the other group will be closed without
      infiltration of Platelet rich plasma
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All cases with disrupted surgical wounds admitted at Obstetrics and Gynecology departments
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients were not allowed to know allocations
measure: Complete wound healing
time frame: 30 days
description: time needed for complete wound closure
measure: Duration of hospital stay
time frame: 30 days
description: Time during which patient is admitted
measure: Failure of complete wound healing
time frame: 30 days
description: No complete closure
measure: Need fo tertiary suture
time frame: 30 days
description: need to re-operate the case again
arm group label: Intervention group
arm group type: Active Comparator
description: All patients in this group will be manged as usual with infiltration of platelet rich plasma in thee wound edges during closure of the wounds
arm group label: Control group
arm group type: Active Comparator
description: All patients in this group will be managed by repair of wounds without infiltration of platelet rich plasma
intervention type: Procedure
intervention name: Platelet rich plasma infiltration in the wound edges
description: platelet rich plasma will be injected in the wound edges
arm group label: Intervention group
intervention type: Procedure
intervention name: Closure of wound without platelet rich plasma infiltration
description: No infiltration of platelet rich plasma is done
arm group label: Control group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Ayman S Dawood, MD
investigator title: Lecturer
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: Yes
ipd description: We will share unidentified data
ipd info type: Study Protocol
ipd time frame: 30 days