<?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>IRCT20180627040252N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-12</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>A comparison between  outcomes of simple suture and vertical mattress suture in palmar incisions</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between  outcomes of simple suture and vertical mattress suture in elective incisions of palmar hand; A prospective clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56548</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The site: https://www.graphpad.com/quickcalcs/randMenu/ is used for randomization. The samples are divided into two random groups based on random numbers created by the site. The letter A is considered for the simple suture group and the letter B is considered for the vertical mattress suture group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Carpal tunnel syndrome. Condition 2: Trigger finger. Condition 3: Trigger thumb.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In this group, patients undergoing carpal tunnel release surgery, trigger finger release and trigger thumb release are sutured with simple sutures. In simple suture, the needle is inserted from a distance of 3-5 mm from one edge of the wound and leaves the other edge of the wound at the same distance. Then a knot is secured. In this group, 4-0 nylon suture is used for skin closure. Intervention 2: Intervention group:  In this group, patients undergoing carpal tunnel release surgery, trigger finger release and trigger thumb release are sutured with vertical mattress sutures. In vertical mattress suture, the needle is inserted 4-8mm from the wound edge and a deep bite of tissue is taken before exiting the skin in the same position on the opposite wound edge. Then, the needle position is reversed in the needle holder, and the needle is inserted 1-2mm from the second side of the wound and a smaller bite of tissue is taken before exiting on the first side of the wound. Then a knot is secured. In this group, 4-0 nylon suture is used for skin closure.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Abdoli Tafti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadougi Hospital, Ebne Sina street, Shahid Ghandi BLvd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916886938</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>aabdoli2000@mail.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Abdoli Tafti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadougi Hospital, Ebne Sina street, Shahid Ghandi BLvd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916886938</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>aabdoli2000@mail.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidate patients for open carpal tunnel release surgery at the surgeon's discretion
Candidate patients for trigger finger release surgery at the surgeon's discretion
Candidate patients for trigger thumb release surgery at the surgeon's discretion
Ability to complete subsequent follow ups
Patients with informed consent</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous history of Palmar surgery
Hand Diseases (Dupuytren, Rheumatoid Arthritis)
Vascular disorders
Systemic diseases (diabetes, rheumatic diseases, malignancies, kidney failure)
Skin diseases (eczema, psoriasis)
Sensitivity to suture material
Use of corticosteroid and cytotoxic drugs
Pregnancy
Previous history of keloid and hypertrophic scars</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.0</hc_code>
      <hc_code>M65.3</hc_code>
      <hc_code>M65.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carpal tunnel syndrome</hc_keyword>
      <hc_keyword>Trigger finger</hc_keyword>
      <hc_keyword>Trigger thumb</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In this group, patients undergoing carpal tunnel release surgery, trigger finger release and trigger thumb release are sutured with simple sutures. In simple suture, the needle is inserted from a distance of 3-5 mm from one edge of the wound and leaves the other edge of the wound at the same distance. Then a knot is secured. In this group, 4-0 nylon suture is used for skin closure.</i_keyword>
      <i_keyword>Intervention group:  In this group, patients undergoing carpal tunnel release surgery, trigger finger release and trigger thumb release are sutured with vertical mattress sutures. In vertical mattress suture, the needle is inserted 4-8mm from the wound edge and a deep bite of tissue is taken before exiting the skin in the same position on the opposite wound edge. Then, the needle position is reversed in the needle holder, and the needle is inserted 1-2mm from the second side of the wound and a smaller bite of tissue is taken before exiting on the first side of the wound. Then a knot is secured. In this group, 4-0 nylon suture is used for skin closure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cosmetic. Timepoint: Third month. Method of measurement: Patient and Observer Scar Assessment Scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Third day, third week, third month. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Infection. Timepoint: Third day, third week. Method of measurement: Southampton Wound Assessment Scale.</prim_outcome>
      <prim_outcome>Patient satisfaction. Timepoint: Third month. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Functional outcome. Timepoint: Third month. Method of measurement: Shortened version of the disabilities of the arm, hand and shoulder Score.</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>Shahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-25</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine- Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Bahonar Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
