<?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>IRCT2014082618939N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-10-06</date_registration>
      <primary_sponsor>Vice chancellor for research, Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>probing effect in contaminated surgical wounds</public_title>
      <acronym></acronym>
      <scientific_title>A survey of wound probing effectiveness on surgical site infection in patients with perforated appendicitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17052</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Other design features: In this survey, after obtaining informed consent and based on inclusion and exclusion criteria, patients are entered in study. A number is granted to each patient in order of entering to study; (from 1 to 114). To randomization, odd numbers are placed in the intervention group and even numbers in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Perforated acute appendicitis.</hc_freetext>
      <i_freetext>Intervention 1: Just a simple dressing is done daily. Intervention 2: Surgical wound probing is done only once a day during hospitalization until the wound is impenetrable. Probing is done with a cotton-tipped, sterile dry swab between stitches to depth of external oblique fascia. Simple dressing is applied after wound probing. Swabs are purchased from Bistoon-Teb company and become sterile in Imam Reza Hospital. Cotton-tipped swab contains no antiseptic or antibiotics.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>   Background: While advances have been made in infection control practices, including prophylactic and sterile methods, surgical site infections remain a substantial cause of morbidity, prolonged hospitalization, and death. But in the age of antibiotic resistance and in order of preventing wound infection, various local methods have been devised. Wound probing is one of them that needs for more investigations.&lt;br /&gt;&#13;
Material and methods: A total of 114 patients with perforated appendicitis were included in this single blind clinical trial. All of them were given standardized preoperative antibiotic and underwent appendectomy through Mc-burney incision with primary closure. They were randomized into two equal groups of control (A) and wound probing (B). In control group we only used simple  daily dressing and in probing group we used a cotton-tipped swab for probing between stitches every morning. Our follow-up for assessing wound infection was at 1 week and 3 weeks after discharge.&lt;br /&gt;&#13;
Results: Of the 114 patients enrolled in this study, there were eleven (9.6%) wound infection (seven in group A and four in group B). In the base of our survey, although the patients in probing group had a lower wound infection (7%) in comparison with control group (12.3%), but statistic analysis did not demonstrate any significant difference (p &gt; 0.05). Hospitalization length and charge, and wound healing were similar between two groups.&lt;br /&gt;&#13;
Conclusion: Use of surgical wound probing in patients underwent appendectomy for perforated appendicitis has no significant effect in preventing wound infection. &lt;br /&gt;&#13;
Keywords: Wound infection, Prophylaxis, Perforated appendicitis, Primary closure, Wound healing&lt;br /&gt;&#13;
</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>Amir Hosein Parniaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Parastar Blvd.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3427 6309</telephone>
        <email>amirparnia@gmil.com; ah.parniaee@kums.ac.ir; dr.makhsosy@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behnam Reza Makhsousi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>General surgery service, Imam Reza Hospital, Parastar Blvd.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3427 6309</telephone>
        <email>dr.makhsosy@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1.Ages between 12-60 years old; 2.Operation via Mc-Burney incision due to acute appendicitis; 3.Evidences of perforated appendicitis e.g., a hole, fecalith, abscess or puss observed by surgeon. &#13;
        Exclusion criteria: 1.Non perforated appendicitis; 2.Incision other than Mc-Burney; 3.Pregnancy; 4.Ages less than 12 years old and more than 60 years old; 5.Severe sepsis and Immunodeficiency, diabetes, cardiovascular or renal or respiratory or hepatic insufficiency; 6.Body mass index higher than 30.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K35.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute appendicitis with perforation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Just a simple dressing is done daily.</i_keyword>
      <i_keyword>Surgical wound probing is done only once a day during hospitalization until the wound is impenetrable. Probing is done with a cotton-tipped, sterile dry swab between stitches to depth of external oblique fascia. Simple dressing is applied after wound probing. Swabs are purchased from Bistoon-Teb company and become sterile in Imam Reza Hospital. Cotton-tipped swab contains no antiseptic or antibiotics.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound infection. Timepoint: Daily during hospitalization, one week and three weeks after discharge. Method of measurement: Based on clinical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospitalization time period. Timepoint: At the time of discharge. Method of measurement: Calculating days of hospitalization.</sec_outcome>
      <sec_outcome>Wound healing. Timepoint: Three weeks after discharge. Method of measurement: Based on clinical examination.</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, Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-07</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, Building No.2, Shahid Beheshty Blvd. Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
