<?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>IRCT2014122220393N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-16</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of grape seed on wound healing</public_title>
      <acronym></acronym>
      <scientific_title>The effect of grape seed ointment (Vitis Vinifera)  on women cesarean wound healing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>129</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18086</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cesarean.</hc_freetext>
      <i_freetext>Intervention 1: A coded package of ointment will be given to the mothers, and they will be trained on how to use it; that is,having washed their hands thouroughly and while wearing disposable gloves, they are expected to rub the ointment as much as the tip of a finger on the stitched area and repeat the steps twice a day (12 hours ± 2) from the second day after the operation to the fifteenth day .Health care points  will be taught to all mothers .on the fifth and twelfth days after cesarean section,the researcher will do the follow-up by phone.Cesarean wound healing will be measured by REEDA scale. in three stages: the second day after surgery, before treatment with ointments, eighth and sixteenth days after surgery. Early intervention will be performed by the researcher and subsequent interventions  by the trained mother. The first stage will be carried out at the hospital, the second stage in the clinic and the third phase by the researcher at the research center of Birjand University of Medical Sciences. Intervention 2: In placebo group, placebo  ointment will use instead of grape seed ointment.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sima.soorgi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No29,Narang 2.1 Alley,Avinne Ave,Birjand</address>
        <city>birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717433693</zip>
        <telephone>+98 56 3234 0109</telephone>
        <email>sima.soorgi@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Mohammad Izadpanah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari Street</address>
        <city>birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>971785357</zip>
        <telephone>+98 56 3244 3042</telephone>
        <email>izadpanahy@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
 Mothers in 37-42 weeks of pregnancy -cesarean with beneath cut- 18 to 35 years of age - BMI in the range of 18/5-25 in early pregnancy - Single fetus – Iranian -no acute or chronic illness - no-disruptive healing (disease i.e Diabetes, kidney disease, anemia, liver disease, mental) –non-consumption of drugs and tobacco  - non-use of drugs affecting wound healing(Glucocorticoids, anticoagulants, immunosuppressant drugs, antibiotics and chemotherapy) - non- allergy grape seed ointment&#13;
Exclusion criteria:&#13;
Unwillingness to continue cooperation – irregular ointment use  and as directed - Complications arising from the use of grape seed ointment - Antibiotics change from the patient's routine - Wound infection</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disruption of caesarean section wound</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A coded package of ointment will be given to the mothers, and they will be trained on how to use it; that is,having washed their hands thouroughly and while wearing disposable gloves, they are expected to rub the ointment as much as the tip of a finger on the stitched area and repeat the steps twice a day (12 hours ± 2) from the second day after the operation to the fifteenth day .Health care points  will be taught to all mothers .on the fifth and twelfth days after cesarean section,the researcher will do the follow-up by phone.Cesarean wound healing will be measured by REEDA scale. in three stages: the second day after surgery, before treatment with ointments, eighth and sixteenth days after surgery. Early intervention will be performed by the researcher and subsequent interventions  by the trained mother. The first stage will be carried out at the hospital, the second stage in the clinic and the third phase by the researcher at the research center of Birjand University of Medical Sciences</i_keyword>
      <i_keyword>In placebo group, placebo  ointment will use instead of grape seed ointment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound Healing. Timepoint: Days of 2, 8,16 after cesarean. Method of measurement: Reeda questionnaire.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-30</approval_date>
        <contact_name>Birjand University of Medical Sciences</contact_name>
        <contact_address>Birjand University of Medical Sciences in Ghaffari Street birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
