<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/NCT04430413</url>
  </required_header>
  <id_info>
    <org_study_id>PRP injection in operated PNS</org_study_id>
    <nct_id>NCT04430413</nct_id>
  </id_info>
  <brief_title>Effect of Platelet Rich Plasma on Healing of Operated Pilonidal Sinus by Open Method</brief_title>
  <official_title>Assessment of the Effect of Platelet Rich Plasma on the Healing of Operated Sacrococcygeal Pilonidal Sinus by Open Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kafrelsheikh University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kafrelsheikh 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>
      The aim of the study is to assess the healing promotion effect of platelet rich plasma in&#xD;
      patient being operated for sacrococcygeal pilonidal sinus disease by open excision&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sacrococcygeal Pilonidal disease is an infection of the skin and subcutaneous tissue at or&#xD;
      near the upper part of the natal cleft of the buttocks. Pilonidal cavities are not true cysts&#xD;
      and lack a fully epithelialized lining; however, the sinus tracts may be epithelialized.&#xD;
&#xD;
      Pilonidal sinus disease (PNS) has an incidence of approximately 26 per 100,000 population&#xD;
      with a male predominance of 2:1 and the mean age of those affected is from 19 to 30 years of&#xD;
      age. It occurs rarely after the age of 45 and children.&#xD;
&#xD;
      Pilonidal sinus disease is characterized by natal cleft suppuration due to hair follicle&#xD;
      infection. The disease results from chronic infection of hair follicles and subsequent&#xD;
      formation of a subcutaneous abscess because of persistent folliculitis. Hair then enters the&#xD;
      abscess cavity and provokes a foreign body tissue reaction; chronic suppuration and discharge&#xD;
      through a midline sinus follow.&#xD;
&#xD;
      Some individuals are asymptomatic with midline pits in the sacrococcygeal area, Symptomatic&#xD;
      Pilonidal sinus results in chronic discharging wounds that cause pain and impact upon quality&#xD;
      of life and social function. These sinuses may become infected and present as acute&#xD;
      abscesses. Management of these abscesses is uncontroversial and revolves around incision and&#xD;
      drainage, however, the mode of surgical management of the chronic discharging sinus is&#xD;
      variable, contentious, and problematic.&#xD;
&#xD;
      The Principles of Surgical strategies require eradication of the sinus tract, complete&#xD;
      healing of the overlying skin, and prevention of recurrence. Many methods are available for&#xD;
      surgical management of PNS which is treated by wide excision. After excision, the wound may&#xD;
      be left open to heal with granulation tissue, or may be immediate closed with a midline&#xD;
      closure or by using a flap (Z-plasty, karydakis, Bascom or Rhomboid flaps). However, there is&#xD;
      not yet a consensus on the optimal treatment.&#xD;
&#xD;
      Excision and healing by granulation is still preferred due to the low recurrence rate of&#xD;
      (3.4%) compering with other methods (20.6%) for midline closure and (10.3%) for off-midline&#xD;
      closure but the healing time is lengthy and requires a prolonged time of daily dressing with&#xD;
      a risk of infection and delayed wound healing. Therefore, the search for a treatment with&#xD;
      minimal pain, accelerated healing time and a short span of time for returning to the normal&#xD;
      daily activities is vastly pursued.&#xD;
&#xD;
      A recent method to promote the wound-healing process is the local administration of an&#xD;
      autologous platelet concentrate suspended in plasma named as platelet rich plasma (PRP) which&#xD;
      contains growth factors. Concentrated growth factors have been reported to accelerate wound&#xD;
      healing by 30-40% giving a satisfactory outcome in the treatment of chronic skin and soft&#xD;
      tissue lesions, maxillofacial and plastic surgeries by presenting these high amounts of&#xD;
      growth factors and chemokines.&#xD;
&#xD;
      When platelets become activated, Seven fundamental protein growth factors that are actively&#xD;
      secreted by platelet initiate all wound healing process, including platelet derived growth&#xD;
      factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular&#xD;
      endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth&#xD;
      factor (CTGF) &amp; insulin like growth factor (ILGF 1) all participate in the acceleration of&#xD;
      wound-healing process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the wound capacity</measure>
    <time_frame>One Year</time_frame>
    <description>Evaluation of Wound volume on postoperative days till complete healing of the wound in each group and compare rate of healing in both groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pilonidal Disease of Natal Cleft</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>50 Participants who underwent a total excision of the pilonidal sinus and the wound remained open for secondary healing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 Participants who underwent the same operation with secondary healing intention but on postoperative days 4 and 12 the platelet rich plasma was injected to the surgical wound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Rich Plasma</intervention_name>
    <description>Autologous PRP obtained via double centrifugation process of the participant's blood sample. PRP was prepared by the double Spain strategy.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient age &gt;18 years and &lt;45 years.&#xD;
&#xD;
          2. All patient who underwent sacrococcygeal pilonidal sinus operation (Open method).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pilonidal abscess.&#xD;
&#xD;
          2. Diabetic patient.&#xD;
&#xD;
          3. HGB &lt; 10 g/dl.&#xD;
&#xD;
          4. Platelet count &lt; 105/ul.&#xD;
&#xD;
          5. Anticoagulant treatment.&#xD;
&#xD;
          6. Wound cavity &gt;35cc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kafr El Sheikh University Hospital</name>
      <address>
        <city>Kafr Ash Shaykh</city>
        <state>Kafr El Sheikh Governorate</state>
        <zip>33511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Acarturk TO, Parsak CK, Sakman G, Demircan O. Superior gluteal artery perforator flap in the reconstruction of pilonidal sinus. J Plast Reconstr Aesthet Surg. 2010 Jan;63(1):133-9. doi: 10.1016/j.bjps.2008.07.017. Epub 2008 Nov 14.</citation>
    <PMID>19010110</PMID>
  </reference>
  <reference>
    <citation>Al-Jaberi TM. Excision and simple primary closure of chronic pilonidal sinus. Eur J Surg. 2001 Feb;167(2):133-5. doi: 10.1080/110241501750070600.</citation>
    <PMID>11266254</PMID>
  </reference>
  <reference>
    <citation>McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006213. doi: 10.1002/14651858.CD006213.pub2.</citation>
    <PMID>17943897</PMID>
  </reference>
  <reference>
    <citation>Anderson JH, Yip CO, Nagabhushan JS, Connelly SJ. Day-case Karydakis flap for pilonidal sinus. Dis Colon Rectum. 2008 Jan;51(1):134-8. doi: 10.1007/s10350-007-9150-y. Epub 2008 Jan 12.</citation>
    <PMID>18193323</PMID>
  </reference>
  <reference>
    <citation>Aksahin E, Dogruyol D, Yuksel HY, Hapa O, Dogan O, Celebi L, Bicimoglu A. The comparison of the effect of corticosteroids and platelet-rich plasma (PRP) for the treatment of plantar fasciitis. Arch Orthop Trauma Surg. 2012 Jun;132(6):781-5. doi: 10.1007/s00402-012-1488-5. Epub 2012 Mar 8.</citation>
    <PMID>22399039</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kafrelsheikh University</investigator_affiliation>
    <investigator_full_name>Mohamed Gohar</investigator_full_name>
    <investigator_title>Assistant Lecturer of General Surgery</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/NCT04430413
org study id: PRP injection in operated PNS
nct id: NCT04430413
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess the healing promotion effect of platelet rich plasma in
      patient being operated for sacrococcygeal pilonidal sinus disease by open excision
Sacrococcygeal Pilonidal disease is an infection of the skin and subcutaneous tissue at or
      near the upper part of the natal cleft of the buttocks. Pilonidal cavities are not true cysts
      and lack a fully epithelialized lining; however, the sinus tracts may be epithelialized.

      Pilonidal sinus disease (PNS) has an incidence of approximately 26 per 100,000 population
      with a male predominance of 2:1 and the mean age of those affected is from 19 to 30 years of
      age. It occurs rarely after the age of 45 and children.

      Pilonidal sinus disease is characterized by natal cleft suppuration due to hair follicle
      infection. The disease results from chronic infection of hair follicles and subsequent
      formation of a subcutaneous abscess because of persistent folliculitis. Hair then enters the
      abscess cavity and provokes a foreign body tissue reaction; chronic suppuration and discharge
      through a midline sinus follow.

      Some individuals are asymptomatic with midline pits in the sacrococcygeal area, Symptomatic
      Pilonidal sinus results in chronic discharging wounds that cause pain and impact upon quality
      of life and social function. These sinuses may become infected and present as acute
      abscesses. Management of these abscesses is uncontroversial and revolves around incision and
      drainage, however, the mode of surgical management of the chronic discharging sinus is
      variable, contentious, and problematic.

      The Principles of Surgical strategies require eradication of the sinus tract, complete
      healing of the overlying skin, and prevention of recurrence. Many methods are available for
      surgical management of PNS which is treated by wide excision. After excision, the wound may
      be left open to heal with granulation tissue, or may be immediate closed with a midline
      closure or by using a flap (Z-plasty, karydakis, Bascom or Rhomboid flaps). However, there is
      not yet a consensus on the optimal treatment.

      Excision and healing by granulation is still preferred due to the low recurrence rate of
      (3.4%) compering with other methods (20.6%) for midline closure and (10.3%) for off-midline
      closure but the healing time is lengthy and requires a prolonged time of daily dressing with
      a risk of infection and delayed wound healing. Therefore, the search for a treatment with
      minimal pain, accelerated healing time and a short span of time for returning to the normal
      daily activities is vastly pursued.

      A recent method to promote the wound-healing process is the local administration of an
      autologous platelet concentrate suspended in plasma named as platelet rich plasma (PRP) which
      contains growth factors. Concentrated growth factors have been reported to accelerate wound
      healing by 30-40% giving a satisfactory outcome in the treatment of chronic skin and soft
      tissue lesions, maxillofacial and plastic surgeries by presenting these high amounts of
      growth factors and chemokines.

      When platelets become activated, Seven fundamental protein growth factors that are actively
      secreted by platelet initiate all wound healing process, including platelet derived growth
      factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular
      endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth
      factor (CTGF) & insulin like growth factor (ILGF 1) all participate in the acceleration of
      wound-healing process.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Assessment of the wound capacity
time frame: One Year
description: Evaluation of Wound volume on postoperative days till complete healing of the wound in each group and compare rate of healing in both groups.
arm group label: Group A
arm group type: No Intervention
description: 50 Participants who underwent a total excision of the pilonidal sinus and the wound remained open for secondary healing.
arm group label: Group B
arm group type: Active Comparator
description: 50 Participants who underwent the same operation with secondary healing intention but on postoperative days 4 and 12 the platelet rich plasma was injected to the surgical wound.
intervention type: Biological
intervention name: Platelet Rich Plasma
description: Autologous PRP obtained via double centrifugation process of the participant's blood sample. PRP was prepared by the double Spain strategy.
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Acarturk TO, Parsak CK, Sakman G, Demircan O. Superior gluteal artery perforator flap in the reconstruction of pilonidal sinus. J Plast Reconstr Aesthet Surg. 2010 Jan;63(1):133-9. doi: 10.1016/j.bjps.2008.07.017. Epub 2008 Nov 14.
PMID: 19010110
citation: Al-Jaberi TM. Excision and simple primary closure of chronic pilonidal sinus. Eur J Surg. 2001 Feb;167(2):133-5. doi: 10.1080/110241501750070600.
PMID: 11266254
citation: McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006213. doi: 10.1002/14651858.CD006213.pub2.
PMID: 17943897
citation: Anderson JH, Yip CO, Nagabhushan JS, Connelly SJ. Day-case Karydakis flap for pilonidal sinus. Dis Colon Rectum. 2008 Jan;51(1):134-8. doi: 10.1007/s10350-007-9150-y. Epub 2008 Jan 12.
PMID: 18193323
citation: Aksahin E, Dogruyol D, Yuksel HY, Hapa O, Dogan O, Celebi L, Bicimoglu A. The comparison of the effect of corticosteroids and platelet-rich plasma (PRP) for the treatment of plantar fasciitis. Arch Orthop Trauma Surg. 2012 Jun;132(6):781-5. doi: 10.1007/s00402-012-1488-5. Epub 2012 Mar 8.
PMID: 22399039
responsible party type: Principal Investigator
investigator affiliation: Kafrelsheikh University
investigator full name: Mohamed Gohar
investigator title: Assistant Lecturer of General Surgery
mesh term: Pilonidal Sinus