<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210926052604N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-21</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the results of pilonidal sinus repair with methods of swing flap and secondary intension</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the results of pilonidal sinus repair with methods of swing flap and secondary intension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59012</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pilonidal sinus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pilonidal sinus repair by swing flap surgery. In this method, the wound repair by displacement of adjacent tissue after removig of pilonidal sinus. Intervention 2: Control group: pilonidal sinus repair by secondary method. the wound is left open and is not repaired In this method, after removing the pilonidal sinus.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed-Ahmad Seyed-Alagheband</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Blvd shohadaye ashayer hospital</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1438863184</zip>
        <telephone>+98 66 3330 5006</telephone>
        <email>Ahmadalagheband@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed-ahmad seyed-alagheband</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Blvd Shohadaye ashayer hospital</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1438863184</zip>
        <telephone>+98 66 3330 5006</telephone>
        <email>Ahmadalagheband@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to participate in the study
Patients referred to Shohada Ashayer Hospital in Khorramabad for pilonidal sinus surgery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with pilonidal sinus abscess
Patient with recurrence of the pilonidal sinus
Patients with purulent hydroadenitis in the sacrococcygeal region
Patient who have risk factors for wound healing (such as iron deficiency anemia, malnutrition, immunodeficiency, diabetes and the use of corticosteroids and anti-metabolic drugs)
pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L05.92</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pilonidal sinus without abscess</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pilonidal sinus repair by swing flap surgery. In this method, the wound repair by displacement of adjacent tissue after removig of pilonidal sinus.</i_keyword>
      <i_keyword>Control group: pilonidal sinus repair by secondary method. the wound is left open and is not repaired In this method, after removing the pilonidal sinus.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of operation. Timepoint: Operation time. Method of measurement: Time to minutes.</prim_outcome>
      <prim_outcome>Postoperative site Infection. Timepoint: First week and Second weak after surgery. Method of measurement: Doctor examination.</prim_outcome>
      <prim_outcome>Hematoma and postoperative bleeding. Timepoint: First week and second week after surgery. Method of measurement: Doctor examination.</prim_outcome>
      <prim_outcome>Surgery site seroma. Timepoint: 1week and 2week and 1month after surgery. Method of measurement: Doctor examination.</prim_outcome>
      <prim_outcome>Flap necrosis. Timepoint: 1weak and 2weak after surgery. Method of measurement: Doctor examination.</prim_outcome>
      <prim_outcome>Recurrence of disease. Timepoint: 3month and 6month after surgery. Method of measurement: Doctor examination.</prim_outcome>
      <prim_outcome>Interval of recurrence of the disease from the first surgery. Timepoint: 6 month after surgery. Method of measurement: Doctor examination.</prim_outcome>
      <prim_outcome>Severity of postoperative position pain. Timepoint: 1weak and 2weak and1month and 3month after surgery. Method of measurement: Visual analogue scale questionnaire.</prim_outcome>
      <prim_outcome>Surgical site scar. Timepoint: 1month and 6month after surgery. Method of measurement: Doctor examination.</prim_outcome>
      <prim_outcome>Wound dehiscence. Timepoint: 1weak and 2weak and 1month after surgery. Method of measurement: Doctor examination.</prim_outcome>
      <prim_outcome>Time of wound healing. Timepoint: 3month and 6month after surgery. Method of measurement: Doctor examinatiob.</prim_outcome>
      <prim_outcome>Return time to daily work. Timepoint: 1 month and 3month after surgery. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Postoperative satisfaction. Timepoint: 6month after surgery. Method of measurement: Licrd satisfaction questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-29</approval_date>
        <contact_name>Ethics committee of Lorestan university of medical sciences</contact_name>
        <contact_address>Enghelab Blvd shohadaye ashayer hospital Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
