<?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>IRCT20190813044523N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-06</date_registration>
      <primary_sponsor>Ramsar Campus - Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Two Suturing Methods in Appendectomy Repairs</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Subcuticular and Semi-matress Suture Size and Complications in Appendectomy Surgical Scar</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41484</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with blocks of 5 Considering the sample size of 50, 10 blocks with 20 cards (10 cards for each group) will be selected; by selecting each block, 5 patients will be assigned into each group.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute appendicitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A (Subcuticular suture): In this group of patients, after appendectomy, the subcutaneous tissue is repaired with absorbable stitches and then, the skin is going to be sutured subcutaneously with 3-0 nylon stitches. In subcuticular suturing method, needle is introduced in beginning of the wound then its run through subcuticular layer of skin. In the end needle exits through the end of the wound. Intervention 2: Intervention group B (Semi-matress suture): In this group of patients, after appendectomy, subcutaneous tissue is repaired with absorbable stitches and then, the skin is sutured with semi-mattress technique with 3-0 nylon stitches. Semi-mattress suturing method is a variant of Vertical mattress sutures, In Semi-mattress method, needle is introduced through edge of the wound then it is run through subdermal layers and after passing through subcuticular layer of the opposite edge, needle exits on the same side of introduction. each suture is done separately.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all collected deidentified data for primary and secondary outcome measures are going to be shared

When:
after publishing the study, data are going to be available

To whom:
data are going to be available to all researchers and clinician irrespective to their employment sector

Conditions:
permission are granted upon request for secondary and meta-analysis

Where to obtain:
requests are gathered through principle researcher's e-mail address

How to obtain:
upon verification of request and reason data are given in three month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hadizadeh Neisanghalb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani St, Taleghani 20th St.</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691786953</zip>
        <telephone>+98 11 5522 6108</telephone>
        <email>h.of.mohammad@gmail.com</email>
        <affiliation>Ramsar Campus - Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hadizadeh Neisanghalb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani St, Taleghani 20th St.</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691786953</zip>
        <telephone>+98 11 5522 6108</telephone>
        <email>h.of.mohammad@gmail.com</email>
        <affiliation>Ramsar Campus - Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Uncomplicated acute appendicitis
Informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Immunodeficiency
BMI&lt;30 kg/m2</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute appendicitis</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 A (Subcuticular suture): In this group of patients, after appendectomy, the subcutaneous tissue is repaired with absorbable stitches and then, the skin is going to be sutured subcutaneously with 3-0 nylon stitches. In subcuticular suturing method, needle is introduced in beginning of the wound then its run through subcuticular layer of skin. In the end needle exits through the end of the wound.</i_keyword>
      <i_keyword>Intervention group B (Semi-matress suture): In this group of patients, after appendectomy, subcutaneous tissue is repaired with absorbable stitches and then, the skin is sutured with semi-mattress technique with 3-0 nylon stitches. Semi-mattress suturing method is a variant of Vertical mattress sutures, In Semi-mattress method, needle is introduced through edge of the wound then it is run through subdermal layers and after passing through subcuticular layer of the opposite edge, needle exits on the same side of introduction. each suture is done separately.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Width of scar. Timepoint: One month after surgical intervention. Method of measurement: Ruler.</prim_outcome>
      <prim_outcome>Aesthetic of surgical scar. Timepoint: One month after surgical intervention. Method of measurement: VAS (visual analog scale).</prim_outcome>
      <prim_outcome>Wound dehiscence. Timepoint: 3rd, 7th and month after surgical intervention. Method of measurement: Physical examination by physician.</prim_outcome>
      <prim_outcome>Pain at surgical site. Timepoint: 3rd and 7th day after surgical intervention. Method of measurement: VAS (visual analog scale).</prim_outcome>
      <prim_outcome>Wound infection. Timepoint: 3rd and 7th day after surgical intervention. Method of measurement: Physical examination by physician.</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>Ramsar Campus - Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-20</approval_date>
        <contact_name>Ethical committe of Ramsar Campus- Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Taleghani St, Taleghani 20 Alley Ramsar Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
