<?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>IRCT20200305046700N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Nylon and Monocryl Sutures for Skin Closure Following Hip Arthroplasty</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Nylon and Monocryl Sutures for Skin Closure and Their Effects on Wound Healing Outcomes in Patients Undergoing Hip Arthroplasty: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91464</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated in a 1:1 ratio to either the nylon or Monocryl suture group. Randomization will be performed using the Sealed Envelope online randomization service. A computer-generated permuted block randomization sequence with variable block sizes of 4 and 6 will be used. The randomization sequence will be generated before recruitment and will not be accessible to investigators responsible for patient enrollment.
For allocation concealment, each assignment will be associated with a sequentially numbered, sealed, opaque card. After confirming eligibility and enrolling the patient, the study secretary will open the next card in sequence and communicate the assigned group to the surgeon immediately before surgery. Thus, the treatment allocation will remain concealed until the patient has been enrolled and randomized, Blinding description: Patients will be blinded to the type of suture used and will not be informed of their group allocation. On the day of surgery, the patient’s group allocation will be communicated to the surgeon by the study secretary.
Postoperative data from patients in groups A and B will be collected and recorded by the study assistants. The data will be coded without identifying the suture type or treatment group and will subsequently be provided to the data analyst. The analyst will remain blinded to group allocation and suture type until completion of the statistical analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Total Hip Arthroplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1 (Nylon Suture): In this group, the wounds will be closed using nylon sutures with interrupted subcutaneous stitches. Intervention 2: Intervention group: Group 2 (Monocryl Suture): In this group, the wounds will be closed using Monocryl sutures with interrupted subcutaneous stitches.</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 not a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Razzaghof</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Joint Reconstruction Research Center, Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6658 1586</telephone>
        <email>m.razzaghof@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Razzaghof</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Joint Reconstruction Research Center, Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6658 1586</telephone>
        <email>m.razzaghof@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients requiring hip replacement surgery, aged 18 to 85 years,
confirmation of patient awareness regarding the study and provision of informed consent.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of prior surgery in the target joint area
patients with inflammatory joint diseases
patients who smoke or consume alcohol
patients with hypoalbuminemia or severe anemia
patients unable to provide informed consent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z96.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of orthopedic joint implants</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1 (Nylon Suture): In this group, the wounds will be closed using nylon sutures with interrupted subcutaneous stitches.</i_keyword>
      <i_keyword>Intervention group: Group 2 (Monocryl Suture): In this group, the wounds will be closed using Monocryl sutures with interrupted subcutaneous stitches.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound pain intensity. Timepoint: Days 5 and 14, and weeks 6 and 12, and months 3 and 6 after surgery. Method of measurement: A numerical scale ranging from 0 to 10, on which the patient self-reports the intensity of pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wound cosmetics. Timepoint: Days 5 and 14, and weeks 6 and 12, and months 3 and 6 after surgery. Method of measurement: POSAS (Patient and Observer Scar Assessment Scale), assessed by both the patient and the observer.</sec_outcome>
      <sec_outcome>Wound complications. Timepoint: Days 5 and 14, and weeks 6 and 12, and months 3 and 6 after surgery. Method of measurement: Clinical assessment and reporting by both the patient and the physician.</sec_outcome>
      <sec_outcome>Wound healing time. Timepoint: Days 5 and 14, and weeks 6 and 12, and months 3 and 6 after surgery. Method of measurement: Assessment of the time required for complete wound healing.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-02</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, International Campus, Office of Vice-President for Educational Affairs, Number 25, Hojat Dost St.,  Felestin St., Keshavarz Blvd., Tehran , Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
