<?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>IRCT2016020418842N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-16</date_registration>
      <primary_sponsor>Vice chancellor for research,Tehran University of Medical Sciences.</primary_sponsor>
      <public_title>The effectiveness of PRP Gel in wound healing caused by resection of Pilonidal sinus</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study on potential of platelet-rich plasma Gel and regular dressing in duration of  wound healing in  patients who underwent pilonidal sinus surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>123</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16975</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Pilonidal Sinus Disease with abscess.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group,the obtained PRP was additionally injected into the depth (13mm) of the wound. It was also applied to center of each circle (0.1cc) and wound site (1 cm in diameter) through injection. The injection was preformed right after surgery and then weekly. Then the PRP Gel (activated by CaCl2) was added 2ml/cm3 of wound volume and the casual dressing performed. Washing the wound with normal saline (0.9%) twice a day was ordered. Wound debridement was also performed to remove the necrotic tissues if necessary. Intervention 2: Classical dressing (sterile absorbent cotton gauze) was applied for the control group. Washing the wound with normal saline (0.9%) twice a day was ordered. Wound debridement was also done in order to remove the necrotic tissues whenever necessary.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kamran Alimoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, North Kargar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2635</telephone>
        <email>alimgh@sina.tums.ac.ir</email>
        <affiliation>Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, North Kargar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2635</telephone>
        <email>saeedm_58@yahoo.com</email>
        <affiliation>Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
Any patient diagnosed with pilonidal sinus disease with a scheduled surgery.&#13;
Exclusion criteria:&#13;
 lower platelet count of &lt;103/µL; hemoglobin &lt;10 mg/dl; anti-proliferative therapies such as chemotherapy and also radiation in past 3 months; anti-inflammation medications in past 2 weeks; growth factor therapies in last 2 weeks, history of diabetes, history of mal-absorption (celiac disease); any contra-indication in peripheral venues access ; not willing to participate in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>47 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L05.02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pilonidal sinus with abscess</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group,the obtained PRP was additionally injected into the depth (13mm) of the wound. It was also applied to center of each circle (0.1cc) and wound site (1 cm in diameter) through injection. The injection was preformed right after surgery and then weekly. Then the PRP Gel (activated by CaCl2) was added 2ml/cm3 of wound volume and the casual dressing performed. Washing the wound with normal saline (0.9%) twice a day was ordered. Wound debridement was also performed to remove the necrotic tissues if necessary.</i_keyword>
      <i_keyword>Classical dressing (sterile absorbent cotton gauze) was applied for the control group. Washing the wound with normal saline (0.9%) twice a day was ordered. Wound debridement was also done in order to remove the necrotic tissues whenever necessary.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound healing time. Timepoint: Weekly up to full healing. Method of measurement: Wound volume measurement by filling the wound with saline. The volume dispensed from the syringe equals the wound volume.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Weekly after start treatment up to average 8 weeks. Method of measurement: Quality of life questionnaire SF12 and 26.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Angiogenesis. Timepoint: In PRP group: between 4-6 weeks  In control group: between 8-10 weeks. Method of measurement: Immuno Histochemistery (IHC)  on biopsy sample.</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>Vice chancellor for research,Tehran University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-24</approval_date>
        <contact_name>Ethics committee of Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran Unive</contact_name>
        <contact_address>Shariat Hospital, North Kargar St. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
