<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/NCT03764657</url>
  </required_header>
  <id_info>
    <org_study_id>OCavalese172018</org_study_id>
    <nct_id>NCT03764657</nct_id>
  </id_info>
  <brief_title>Pilonidal Sinus Disease: Preliminare Study</brief_title>
  <official_title>Pilonidal Sinus Disease: Preliminary Case-control Study on Heat-related Wound Dehiscence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale di Cavalese</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale di Cavalese</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>
      Pilonidal disease is morbid condition of young productive population, that could impair&#xD;
      quality of life with high cost for health care system. No consensus exists on optimal&#xD;
      surgical treatment, even if several techniques have been proposed. In this preliminary&#xD;
      experimental case-control study the investigators compared excision by knife and diathermy&#xD;
      with the aim to investigate if wound dehiscence could be related to heat spreading during&#xD;
      excision of the sinus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between January 2017 and February 2018, 29 patients underwent to sinus excision. The&#xD;
      investigators considered 16 sinus excision performed by diathermy as a case group (named&#xD;
      &quot;Hot&quot; group) and the last 13 procedures performed by knife as control group (named &quot;Cold&quot;&#xD;
      group). Temperature data were recorded for both group. Follow-up was carried out until&#xD;
      complete healing. Were considered primary and secondary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Number of complete wound healed and not healed after 8 postoperative days</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>We established as primary outcomes, the number of wound completely healed after 8-12 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>types of complications (Dindo-Clavien)</measure>
    <time_frame>follow-up 12 months</time_frame>
    <description>the type of complication was divided into 2 types, Grade I and II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative pain in first postoperative day (analogue pain score, VAS)</measure>
    <time_frame>7 days</time_frame>
    <description>postoperative pain was recorded in the two groups using the analog pain scale (VAS, range 0-10, the lowest value indicates less pain and the highest value indicates)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operative time for complete excision of the sinus (minutes)</measure>
    <time_frame>minutes (range 0-30 minutes)</time_frame>
    <description>the operative time for complete excision was compared into the two group</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Pilonidal Sinus</condition>
  <arm_group>
    <arm_group_label>16 patients, named &quot;Hot&quot; group</arm_group_label>
    <description>We considered 16 sinus excision by diathermy as a case group (named &quot;Hot&quot; group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>13 patients, named &quot;Cold group&quot;</arm_group_label>
    <description>13 procedures performed by knife as control group (named &quot;Cold&quot; group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>In &quot;hot&quot; group 16 patients were treated by diathermy in &quot;Cold&quot;</intervention_name>
    <description>In all interventions, the patients were placed in prone position on operating table with the gluteal line opened wide by adhesive patches; after skin disinfection, dimension and extension of cystic disease was studied by injection of hydrogen peroxide through superficial skin orifice. The same procedure was performed: an elliptical incision on midline around the sinus was made and the sinus was excided laterally and in depth on healthy tissue, down till the pre-sacral fascia: this common approach was made both using scalpel and electrosurgery in the two groups. During dissection and excision, in each group were measured and recorded the temperatures developing, both on the section surface using an infrared thermometer and thermal imaging camera, and deeper until 1 cm from the section frontline using a &quot;immersion thermometer&quot; sealed by a steri-drape to guarantee the sterility on surgical field. In this group excision was carried out with diatermocoagulation</description>
    <arm_group_label>13 patients, named &quot;Cold group&quot;</arm_group_label>
    <arm_group_label>16 patients, named &quot;Hot&quot; group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>in &quot;Cold&quot; group 13 patients were treated by scalpel.</intervention_name>
    <description>the position and preparation of the patient on the operating table were the same as in the &quot;hot&quot; group, while the excision procedure performed with knife</description>
    <arm_group_label>13 patients, named &quot;Cold group&quot;</arm_group_label>
    <arm_group_label>16 patients, named &quot;Hot&quot; group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients were enrolled by outpatient surgical control for signs and symptoms of chronic&#xD;
        sinus referred to us by a family doctor; median age was 19.2 ± 4.3 years, ranging from 14&#xD;
        to 52 years old; 6 patients were females and 23 males and them were request to give&#xD;
        informed consensus to underwent to pilonidal sinus excision; 16 patients of whom 12 males&#xD;
        and 4 females, were treated by electrosurgery as case group (&quot;hot&quot;), while in the control&#xD;
        group (&quot;cold&quot;), 13 patients 11 were male and 2 were females.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male and female patients between 14 and 65 years old,&#xD;
&#xD;
          -  primary, non recurrent pilonidal disease&#xD;
&#xD;
          -  midline and intergluteal location&#xD;
&#xD;
          -  spinal anesthesia&#xD;
&#xD;
          -  dimension no more than 5 cm in length, primary closure performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 14 and &gt; 65 years old,&#xD;
&#xD;
          -  secondary fistulous tracts or lateral developing/cutaneous opening&#xD;
&#xD;
          -  dimension over 5 cm in length,&#xD;
&#xD;
          -  local anesthesia employ&#xD;
&#xD;
          -  smoker and obese patients (BMI&gt; 25 kg/m2)&#xD;
&#xD;
          -  diabetic and coagulopathies affected one&#xD;
&#xD;
          -  flogged or acute or infected or abscessed forms&#xD;
&#xD;
          -  ASA score &gt; IV,&#xD;
&#xD;
          -  normal range WBC and Hb preoperative values.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>52 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ospedale di Cavalese</name>
      <address>
        <city>Cavalese</city>
        <state>Trento</state>
        <zip>38033</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pilonidal sinus disease</keyword>
  <keyword>wound deiscence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pilonidal Sinus</mesh_term>
    <mesh_term>Paranasal Sinus Diseases</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/NCT03764657
org study id: OCavalese172018
nct id: NCT03764657
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pilonidal disease is morbid condition of young productive population, that could impair
      quality of life with high cost for health care system. No consensus exists on optimal
      surgical treatment, even if several techniques have been proposed. In this preliminary
      experimental case-control study the investigators compared excision by knife and diathermy
      with the aim to investigate if wound dehiscence could be related to heat spreading during
      excision of the sinus.
Between January 2017 and February 2018, 29 patients underwent to sinus excision. The
      investigators considered 16 sinus excision performed by diathermy as a case group (named
      "Hot" group) and the last 13 procedures performed by knife as control group (named "Cold"
      group). Temperature data were recorded for both group. Follow-up was carried out until
      complete healing. Were considered primary and secondary outcomes.
observational model: Case-Control
time perspective: Prospective
measure: Number of complete wound healed and not healed after 8 postoperative days
time frame: Up to 4 weeks
description: We established as primary outcomes, the number of wound completely healed after 8-12 days
measure: types of complications (Dindo-Clavien)
time frame: follow-up 12 months
description: the type of complication was divided into 2 types, Grade I and II
measure: post-operative pain in first postoperative day (analogue pain score, VAS)
time frame: 7 days
description: postoperative pain was recorded in the two groups using the analog pain scale (VAS, range 0-10, the lowest value indicates less pain and the highest value indicates)
measure: operative time for complete excision of the sinus (minutes)
time frame: minutes (range 0-30 minutes)
description: the operative time for complete excision was compared into the two group
arm group label: 16 patients, named "Hot" group
description: We considered 16 sinus excision by diathermy as a case group (named "Hot" group)
arm group label: 13 patients, named "Cold group"
description: 13 procedures performed by knife as control group (named "Cold" group).
intervention type: Procedure
intervention name: In "hot" group 16 patients were treated by diathermy in "Cold"
description: In all interventions, the patients were placed in prone position on operating table with the gluteal line opened wide by adhesive patches; after skin disinfection, dimension and extension of cystic disease was studied by injection of hydrogen peroxide through superficial skin orifice. The same procedure was performed: an elliptical incision on midline around the sinus was made and the sinus was excided laterally and in depth on healthy tissue, down till the pre-sacral fascia: this common approach was made both using scalpel and electrosurgery in the two groups. During dissection and excision, in each group were measured and recorded the temperatures developing, both on the section surface using an infrared thermometer and thermal imaging camera, and deeper until 1 cm from the section frontline using a "immersion thermometer" sealed by a steri-drape to guarantee the sterility on surgical field. In this group excision was carried out with diatermocoagulation
arm group label: 13 patients, named "Cold group"
arm group label: 16 patients, named "Hot" group
intervention type: Procedure
intervention name: in "Cold" group 13 patients were treated by scalpel.
description: the position and preparation of the patient on the operating table were the same as in the "hot" group, while the excision procedure performed with knife
arm group label: 13 patients, named "Cold group"
arm group label: 16 patients, named "Hot" group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 52 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Pilonidal Sinus
mesh term: Paranasal Sinus Diseases
sharing ipd: Undecided