<?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>IRCT20220522054960N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-12</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of egg white formulation on bed sore healing</public_title>
      <acronym></acronym>
      <scientific_title>The effect of egg white formulation on bed sore healing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63915</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: Random assignment of patients to intervention and control groups will be done by block random method using 6 blocks. In each block, 3 people will be in the intervention group and 3 people in the control group, but the order of placement will be It will be a random form that will be done with WinPepi software, Blinding description: In this study, the manufacturer of the formulation numbered the container containing the drug formula and the placebo, while none of the participants in the study included the researcher, clinical caregiver, outcome assessor, data analyst, and content monitoring committee. Every dish is unknowingly studied.</study_design>
      <phase>3</phase>
      <hc_freetext>Compression ulcer, which is a disorder of skin cohesion, occurs due to the compression of the soft tissue between the skeletal joints and an external surface such as the bed or chair..</hc_freetext>
      <i_freetext>This study examined second- and third-degree wounds and none of the patients are deprived of their main treatment, which is a daily dressing with phenytoin ointment or camphil dressing. The treatment protocol is such that patients' wound dressings are changed daily according to the hospital dressing routine. In this way, after preparing the dressing changing equipment, including sterile gloves, sterile gauze, washing serum, sterilized changing dressing set and hand glue with washed water and soap, then the previous dressing is removed along with the process of changing the previous dressing position. The wound is examined ، After wearing sterile gloves, the wound is washed with serum and dried with sterile gauze. Then, the egg white formulation is used in the intervention group and placebo in the control group with phenytoin cream or camphile, depending on the doctor's prescription. The wound is bandaged. Wounds are then examined at the end of each week for four weeks according to push criteria. Using the push tool, three criteria of wound size, amount of secretions and type of tissue formed in the wound are detected and scored. Sampling of samples in both intervention and control groups is performed by the researcher. Because environmental factors may affect the observer, two observers are used to score in the observed position. In order to prevent bias from the wounds of patients in the treatment process, digital photos are taken and the photos are examined by the third observer, who is not aware of the type of dressing, in terms of the healing process. The observer is required to read the completed questionnaire for patients as soon as possible after observation, in order to avoid inconsistencies and ambiguities due to the time interval between observation and study..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Tadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Karun 3 Complex, between Dey and Bahman St, Shahrivar St, Golestan.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135935700</zip>
        <telephone>+98 38 3372 4813</telephone>
        <email>atefehtadi@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh  Tadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Karun 3 Complex, between Dey and Bahman St, Shahrivar St, Golestan.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135935700</zip>
        <telephone>+98 38 3372 4813</telephone>
        <email>atefehtadi@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Age over 18 years
2. Clinical diagnosis of grade 2 and 3 pressure ulcers
3. Hospitalized in the intensive care unit of Golestan and Imam Ahvaz hospitals
4. Antibiotic use was the same in both groups
5. No cancer
6. Do not use immunosuppressants
7. Do not have chronic diseases that affect the wound healing process, such as diabetes, severe vascular disease, lupus, rheumatoid arthritis and kidney failure, which is determined by the patient's medical history and record.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pressure ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study examined second- and third-degree wounds and none of the patients are deprived of their main treatment, which is a daily dressing with phenytoin ointment or camphil dressing. The treatment protocol is such that patients' wound dressings are changed daily according to the hospital dressing routine. In this way, after preparing the dressing changing equipment, including sterile gloves, sterile gauze, washing serum, sterilized changing dressing set and hand glue with washed water and soap, then the previous dressing is removed along with the process of changing the previous dressing position. The wound is examined ، After wearing sterile gloves, the wound is washed with serum and dried with sterile gauze. Then, the egg white formulation is used in the intervention group and placebo in the control group with phenytoin cream or camphile, depending on the doctor's prescription. The wound is bandaged. Wounds are then examined at the end of each week for four weeks according to push criteria. Using the push tool, three criteria of wound size, amount of secretions and type of tissue formed in the wound are detected and scored. Sampling of samples in both intervention and control groups is performed by the researcher. Because environmental factors may affect the observer, two observers are used to score in the observed position. In order to prevent bias from the wounds of patients in the treatment process, digital photos are taken and the photos are examined by the third observer, who is not aware of the type of dressing, in terms of the healing process. The observer is required to read the completed questionnaire for patients as soon as possible after observation, in order to avoid inconsistencies and ambiguities due to the time interval between observation and study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound healing is the healing and return of complete health to the damaged tissue in this study Acupressure wound healing means that according to the standard dressing checklist, the score given to the wound is reduced compared to the initial score (week zero). Timepoint: End each week for four weeks. Method of measurement: Wound measurement and control tools, which consist of three criteria: wound size, amount of secretions and type of tissue, examine the wound and determine the wound healing status by combining these three criteria. In this checklist, the extent of the wound is 10-0. The amount of wound discharge is 0-3 and the type of wound tissue is 0-4. A score of zero indicates wound healing and a highest score of 17 indicates wound healing.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-07</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Golestan Alley, Esfand St., Ahvaz University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
