<?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>IRCT20230917059444N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-12</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Effects of early showering after coronary artery bypass graft surgery on wound infection, pain and patient comfort.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of early showering after coronary artery bypass graft surgery on wound infection, pain and patient comfort.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72627</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomized into two groups: early shower and late shower. Patients are not blinded. The data analyst will not be aware of the allocation of patients to groups. The selection of samples will be continuous and the allocation of samples to two groups will be done using the website https://www.sealedenvelope.com/, Blinding description: Patients are not blinded. The data analyst will not be aware of the allocation of patients to groups. The infectious specialist will not be aware of the division of groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Effects of early showering after coronary artery bypass graft surgery on wound infection. Condition 2: Effects of early showering on pain after coronary artery bypass graft surgery. Condition 3: Effects of early showering after coronary artery bypass surgery on patient comfort.</hc_freetext>
      <i_freetext>Intervention group: Preparation of culture from the nose to determine the carrier of nasal staphylococcus aureus before the operation, cutting the hair of the operation area and taking a shower before the operation, taking a written consent and completing the demographic information, dressing the wound with sterile gauze after the operation, Removal of chest tubes 48 to 72 hours after the operation by a nurse, performing a chest x-ray to check the possible complications of drain removal (such as pneumothorax) and evaluation by the surgeon, cleaning and disinfection of the bathroom environment by the service personnel, 4 to 6 hours later The wound dressings are removed from the exit of the chest tubes and while the place of exit of the chest tubes is covered with a waterproof dressing (of the same brand for all patients),Take a shower without rubbing or washing the wound strongly, with tap water, the total showering time will be 10 minutes, to maintain safety, patients sit on a chair and use the shower, to prevent hypothermia, the temperature of the bath is between 20 and 23 The temperature is maintained, for each patient, a separate slipper and a clean cover are used to throw on the chair, before going to the bathroom, vital signs and arterial blood oxygen saturation percentage of the patients are controlled, After bathing, do not get up suddenly from the chair, sit in a sitting position for at least 3 minutes, dry the body and the incision site with a sterilized towel, and the patient puts on his clothes, the waterproof dressing is removed from the place where the drains exit and The wound area is covered with antiseptic betadine and then with sterile gauze and straw glue, The wound of the sternotomy area is kept clean and open with betadine, the wound of the graft removal area of ​​the leg (saphenous vein outlet) is left and a varicose sock is worn. It is done up to 72 hours after the operation and then daily before showering. The first assessment of pain and comfort is done 48 to 72 hours after the operation and then daily 30 minutes after showering by the researcher. On the 14th day after the operation, the researcher comes to the clinic and evaluates pain and comfort, and the wound is evaluated for the possible occurrence of signs of infection on the same day in the clinic by an infectious specialist..</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Safarabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Street, Above Mirdamad Crossroads, Valiasr Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19967</zip>
        <telephone>+98 21 8123 5297</telephone>
        <email>mohsensafarabadi313@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Safarabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Street, Above Mirdamad Crossroads, Valiasr Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19967</zip>
        <telephone>+98 21 8123 5297</telephone>
        <email>mohsensafarabadi313@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 18 years
Ability to speak Persian
Performing CABG through median sternotomy and under cardiopulmonary pump
Removal of chest tubes 48 to 72 hours after surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cognitive disorders
Physical disorders
Prolonged exit of chest tubes after 72 hours
Need to go back to the operating room
In the data collection process, patients who develop postoperative complications such as cardiac tamponade, pleural effusion, or pneumonia, are transferred to another hospital, or require reoperation will be excluded.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Preparation of culture from the nose to determine the carrier of nasal staphylococcus aureus before the operation, cutting the hair of the operation area and taking a shower before the operation, taking a written consent and completing the demographic information, dressing the wound with sterile gauze after the operation, Removal of chest tubes 48 to 72 hours after the operation by a nurse, performing a chest x-ray to check the possible complications of drain removal (such as pneumothorax) and evaluation by the surgeon, cleaning and disinfection of the bathroom environment by the service personnel, 4 to 6 hours later The wound dressings are removed from the exit of the chest tubes and while the place of exit of the chest tubes is covered with a waterproof dressing (of the same brand for all patients),Take a shower without rubbing or washing the wound strongly, with tap water, the total showering time will be 10 minutes, to maintain safety, patients sit on a chair and use the shower, to prevent hypothermia, the temperature of the bath is between 20 and 23 The temperature is maintained, for each patient, a separate slipper and a clean cover are used to throw on the chair, before going to the bathroom, vital signs and arterial blood oxygen saturation percentage of the patients are controlled, After bathing, do not get up suddenly from the chair, sit in a sitting position for at least 3 minutes, dry the body and the incision site with a sterilized towel, and the patient puts on his clothes, the waterproof dressing is removed from the place where the drains exit and The wound area is covered with antiseptic betadine and then with sterile gauze and straw glue, The wound of the sternotomy area is kept clean and open with betadine, the wound of the graft removal area of ​​the leg (saphenous vein outlet) is left and a varicose sock is worn. It is done up to 72 hours after the operation and then daily before showering. The first assessment of pain and comfort is done 48 to 72 hours after the operation and then daily 30 minutes after showering by the researcher. On the 14th day after the operation, the researcher comes to the clinic and evaluates pain and comfort, and the wound is evaluated for the possible occurrence of signs of infection on the same day in the clinic by an infectious specialist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people with wound infection. Timepoint: Measurement of wound infection rate 48 hours after surgery and daily before showering until discharge and 14 days after surgery. Method of measurement: The profile of the incidence of surgical site infection.</prim_outcome>
      <prim_outcome>Pain score on visual analog scale. Timepoint: Measuring the pain score 48 hours after the operation and daily after showering until discharge and on the 14th day after the operation. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Patient comfort score on visual analog scale. Timepoint: Measuring the patient's comfort score 48 hours after the operation and daily after taking a shower until discharge and on the 14th day after the operation. Method of measurement: Visual analog scale.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-10</approval_date>
        <contact_name>Ethics Committee of Shahed University</contact_name>
        <contact_address>At the beginning of Tehran-Qom freeway, in front of Imam Khomeini's shrine Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
