<?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>IRCT20220516054869N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-07</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation and comparison of the incidence of infection of repaired wound wounds with different dressing models in the emergency room</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of the incidence of infection of repaired wound wounds with different dressing models in the emergency room</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63574</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: .Random allocation of patients to two groups is done by permuted block stratified randomization. In this way, first, the eligible patients are classified according to age and sex, respectively. Then, based on 6 blocks (consisting of three groups A, B and C and two repetitions for each) that are randomly selected from all possible modes of permutations, they are assigned to the desired group. These blocks are created using R statistical software version 4.0.2. These codes are located in a sealed package to hide the allocation in the envelope, which will be assigned to patients in order.
Matching

The two groups are matched in terms of age and sex (Frequency matching) using the permutation block stratified randomization method, Blinding description: The outcome assessor and data analyst are unaware of the types of interventions (different dressing models).</study_design>
      <phase>3</phase>
      <hc_freetext>Sutured wound infection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dressing with sterile gauze impregnated with saline. Put a layer of 0.9% saline-impregnated gas on the wound and then put a layer of dry sterile gas on it and fix it on the skin with glue. We change the dressing for up to 7 sessions daily. Intervention 2: Intervention group: Gas stove to Vaseline. Put a layer of Vaseline impregnated gas on the wound and then put a layer of dry sterile gas on it and then fix it on the wound with glue. We change the dressing up to 7 times a day. Intervention 3: Intervention group: Gas tetracycline-impregnated topical antibiotic gas. Apply a layer of tetracycline topical antibiotic-impregnated gas to the wound, then apply a layer of dry sterile gauze, and then fix the adhesive to the wound. We change the dressing up to 7 times a day.</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 data is potentially shareable after unidentifiable individuals

When:
Access period starts 6 months after the results are published

To whom:
The data will be available to researchers, including in laboratory and scientific institutions.

Conditions:
In order to use the data in research work and after sending the request, if the researcher agrees, the data responsible will be provided to the applicant.

Where to obtain:
Correspond with the responsible researcher (Ali Abdolrazaqnejad) via email.

How to obtain:
After submitting the request, the applicant will have access to the data up to 1 month after the request, if he / she meets the conditions.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ali abdolrazaghnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3323 2890</telephone>
        <email>ali.abdorazzagh@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ali abdolrazaghnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>daneshgah blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3323 2890</telephone>
        <email>ali.abdorazzagh@gamil.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with limb wounds who are admitted to the emergency room of Khatam Al-Anbi Hospital for wound healing.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients receiving antibiotics while taking injectable antibiotics.
Wounds that have healed in more than one layer.
People with immunodeficiency / chronic corticosteroids / DM
Wounds caused by animal bites
Wounds with fractures
People with chronic internal diseases (RF / RA / SLE / endocrine disorders)
Clearly dirty wounds
Complex, crushed and twisted wounds
The size of the wounds is more than 20 cm
Wounds that have been repaired in other centers and referred to the emergency room of Khatam Al-Anbia Hospital for dressing.
Patients who have referred for wound healing for more than 6 hours
People with malnutrition, obesity and smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dressing with sterile gauze impregnated with saline. Put a layer of 0.9% saline-impregnated gas on the wound and then put a layer of dry sterile gas on it and fix it on the skin with glue. We change the dressing for up to 7 sessions daily.</i_keyword>
      <i_keyword>Intervention group: Gas stove to Vaseline. Put a layer of Vaseline impregnated gas on the wound and then put a layer of dry sterile gas on it and then fix it on the wound with glue. We change the dressing up to 7 times a day.</i_keyword>
      <i_keyword>Intervention group: Gas tetracycline-impregnated topical antibiotic gas. Apply a layer of tetracycline topical antibiotic-impregnated gas to the wound, then apply a layer of dry sterile gauze, and then fix the adhesive to the wound. We change the dressing up to 7 times a day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound infection (having or not having). Timepoint: Daily up to 7 days after the initial dressing. Method of measurement: check list.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-17</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Daneshgah blvd Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
