<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/NCT02246192</url>
  </required_header>
  <id_info>
    <org_study_id>Sinusprgf</org_study_id>
    <nct_id>NCT02246192</nct_id>
  </id_info>
  <brief_title>Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision</brief_title>
  <official_title>Application of PRGF (Plasma Rich in Growth Factors) to Reduce the Healing Time After Pilonidal Sinus Excision. A Randomized 5-years Prospective Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Quiron Sagrado Corazon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Quiron Sagrado Corazon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the&#xD;
      healing process of the wound, when compared with the usual technique of daily local healing.&#xD;
      The investigators propose the objective of evaluating the efficacy of intra- and&#xD;
      postoperative application of plasma rich in growth factors, to reduce healing time and&#xD;
      complications, arising from its removal, compared to the standard surgical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      prospective randomized control trial, comparing PRGF application vs daily local care(betadine&#xD;
      +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and&#xD;
      infiltrated in the pilonidal wound every week. this treatment is compared with betadine and&#xD;
      saline wound care in terms of wound healing time, pospoperative pain and other complications.&#xD;
&#xD;
      this study try to keeps the advantages of using open technique for pilonidal desease( low&#xD;
      recurrence rate and surgical site infections) and improving the disadvantages (high wound&#xD;
      healing time and postperative pain with wore quality of life) when it´s compared with direct&#xD;
      closure or flap techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>healing time(days) of pilonidal sinus wound excision</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>1 month</time_frame>
    <description>using VAS to assess postoperative pain</description>
  </secondary_outcome>
  <other_outcome>
    <measure>postoperative bleeding</measure>
    <time_frame>1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>surgical site infection rate</measure>
    <time_frame>1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>sinus recurrence rate</measure>
    <time_frame>4 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Pilonidal Sinus</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sinus pilonidal excision and standard cares</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRGF group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sinus pilonidal excision+ PRGF</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sinus pilonidal excision+ PRGF</intervention_name>
    <description>open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively</description>
    <arm_group_label>PRGF group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sinus pilonidal excision and standard cares</intervention_name>
    <description>sinus pilonidal excision and postoperative standard care with povidone daily</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients among 13 and 65 years old&#xD;
&#xD;
          -  Possibility of observation during the follow-up period&#xD;
&#xD;
          -  Patients who have read and signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abscessed pilonidal sinus&#xD;
&#xD;
          -  Recurrent pilonidal sinus&#xD;
&#xD;
          -  Patients treated with immunosuppressive drugs or anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Bellido Luque</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quirón Sagrado Corazón Hospital, Seville, Spain</affiliation>
  </overall_official>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>March 18, 2015</last_update_submitted>
  <last_update_submitted_qc>March 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Quiron Sagrado Corazon</investigator_affiliation>
    <investigator_full_name>Juan Bellido Luque.MD</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pilonidal Sinus</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/NCT02246192
org study id: Sinusprgf
nct id: NCT02246192
lead sponsor: 
has dmc: Yes
The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the
      healing process of the wound, when compared with the usual technique of daily local healing.
      The investigators propose the objective of evaluating the efficacy of intra- and
      postoperative application of plasma rich in growth factors, to reduce healing time and
      complications, arising from its removal, compared to the standard surgical treatment.
prospective randomized control trial, comparing PRGF application vs daily local care(betadine
      +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and
      infiltrated in the pilonidal wound every week. this treatment is compared with betadine and
      saline wound care in terms of wound healing time, pospoperative pain and other complications.

      this study try to keeps the advantages of using open technique for pilonidal desease( low
      recurrence rate and surgical site infections) and improving the disadvantages (high wound
      healing time and postperative pain with wore quality of life) when it´s compared with direct
      closure or flap techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: healing time(days) of pilonidal sinus wound excision
time frame: 6 months
measure: postoperative pain
time frame: 1 month
description: using VAS to assess postoperative pain
measure: postoperative bleeding
time frame: 1 week
measure: surgical site infection rate
time frame: 1 month
measure: sinus recurrence rate
time frame: 4 years
measure: quality of life
time frame: 6 months
description: this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly.
arm group label: control group
arm group type: Experimental
description: sinus pilonidal excision and standard cares
arm group label: PRGF group
arm group type: Experimental
description: sinus pilonidal excision+ PRGF
intervention type: Procedure
intervention name: sinus pilonidal excision+ PRGF
description: open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively
arm group label: PRGF group
intervention type: Procedure
intervention name: sinus pilonidal excision and standard cares
description: sinus pilonidal excision and postoperative standard care with povidone daily
arm group label: control group
criteria: 
gender: All
minimum age: 13 Years
maximum age: 65 Years
healthy volunteers: No
last name: Juan Bellido Luque
role: Principal Investigator
affiliation: Quirón Sagrado Corazón Hospital, Seville, Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Quiron Sagrado Corazon
investigator full name: Juan Bellido Luque.MD
investigator title: Ph.D
mesh term: Pilonidal Sinus