<?xml version="1.0" encoding="UTF-8"?>

<trials>

    <trial>
        <main>
            <trial_id>RBR-7b5ycz</trial_id>
            <utrn>U1111-1128-5307</utrn>
            <reg_name>REBEC</reg_name>
            <date_registration>26/04/2012</date_registration>
            <primary_sponsor>Universidade Federal do Paraná - Curitiba, PR, Brazil</primary_sponsor>
            <public_title>Evaluation of dressing for central venous catheter</public_title>
            <acronym></acronym>
            <scientific_title>Evaluation of the effectiveness of the chlorhexidine antimicrobial dressing for central venous catheter</scientific_title>
            <scientific_acronym>: ClorHexidine Gluconate-Central Venous Catheter</scientific_acronym>
            <date_enrolment>17/10/2011</date_enrolment>
            <type_enrolment>actual</type_enrolment>
            <target_size>84</target_size>
            <recruitment_status>recruiting</recruitment_status>
            <url>http://www.ensaiosclinicos.gov.br/rg/RBR-7b5ycz/</url>
            <study_type></study_type>
            <study_design>Preventive, parallel, 2-arms, open, randomized controlled clinical trial.</study_design>
            <phase>N/A</phase>
            <hc_freetext>Catheter-related bloodstream infection

</hc_freetext>
            <i_freetext>84 patients using the first central venous catheter within 24 hours of insertion of the short-term catheter will be randomized to form two groups. Study group: 42 patients receive curative antimicrobial chlorhexidine. Control group: 42 patients receive Sterile gauze. The patient will be monitored and evaluated daily by the research team for collection of signs and symptoms, medications used, the dressing conditions and socio-demographic data. The dressing is changed every seven days in the study group and control group in every 48 hours, or when loose, moist dirt or signs that compromise its integrity. Patients will be followed until catheter removal or even puncture a second central catheter.</i_freetext>            
        </main>
        <contacts>
        
            <contact>
                <type>public</type>
                <firstname>Edivane</firstname>
                <middlename></middlename>
                <lastname>Pedrolo</lastname>
                <address>Av. Prof. Lothario Meissner, 632, sala 12, 3 andar</address>
                <city>Curitiba</city>
                <country1>Brazil</country1>
                <zip>80210170</zip>
                <telephone>41 99255226</telephone>
                <email>edivanepedrolo@gmail.com</email>
                <affiliation>Universidade Federal do Paraná</affiliation>
            </contact>
        
        
            <contact>
                <type>scientific</type>
                <firstname>Edivane</firstname>
                <middlename></middlename>
                <lastname>Pedrolo</lastname>
                <address>Av. Prof. Lothario Meissner, 632, sala 12, 3 andar</address>
                <city>Curitiba</city>
                <country1>Brazil</country1>
                <zip>80210170</zip>
                <telephone>41 99255226</telephone>
                <email>edivanepedrolo@gmail.com</email>
                <affiliation>Universidade Federal do Paraná</affiliation>
            </contact>
        
        </contacts>
        <countries>
        
            <country2>Brazil</country2>
        
        </countries>
        <criteria>
            <inclusion_criteria>Over 18 years;
Hospitalization in the Intensive Care Unit (ICU) or Semi Intensive (CTSI) Adult;
In the first use of central venous catheter (CVC) for short stay less than 24 hours;
Signing the consent form;
No known sensitivity to materials of the dressings.
</inclusion_criteria>
            <agemin>18Y</agemin>
            <agemax>100Y</agemax>
            <gender>-</gender>
            <exclusion_criteria>Refusal by the patient or explained by the family to participate in the research;
By shaving blade at the site of catheter insertion prior to puncture;
Sweating or bleeding from the orifice of the catheter;
Temperature above 38 ° C during puncture of the catheter.</exclusion_criteria>
        </criteria>
        <health_condition_code>
            
            <hc_code>C01</hc_code>
            
        </health_condition_code>
        <health_condition_keyword>
            
            <hc_keyword>C01.539.195</hc_keyword>
            
        </health_condition_keyword>
        <intervention_code>
            
            <i_code>other</i_code>
            
        </intervention_code>
        <intervention_keyword>
            
            <i_keyword>E07.132</i_keyword>
            
        </intervention_keyword>
        <primary_outcome>
            
            <prim_outcome>Reduction of bloodstream infection related to the catheter by the use of antimicrobial chlorhexidine dressings as measured by infection rate per thousand catheter days in both groups.</prim_outcome>
            
        </primary_outcome>
        <secondary_outcome>
            
            <sec_outcome>Increased rate of fixation of the skin healing evaluated by displacement of borders with or without compromising the integrity of the dressing. Will be considered adequate fixation when the dressing remains intact.</sec_outcome>
            
            <sec_outcome>Reduction of local reaction to the healing assessed by the absence of itching, redness, scaling and maceration in the region of contact with skin healing.</sec_outcome>
            
        </secondary_outcome>
        <secondary_sponsor>
            
            <sponsor_name>3M do Brasil - Sumaré, SP, Brazil</sponsor_name>
            
        </secondary_sponsor>
        <secondary_ids>
            
            <secondary_id>
                <sec_id>CAAE 0067.0.091.208-11</sec_id>
                <issuing_authority>Comitê de Ética em Pesquisa do Setor de Ciências da Saúde da Universidade Federal do Paraná</issuing_authority>    
            </secondary_id>
            
            <secondary_id>
                <sec_id>CEP/SD 1145.070.11.06</sec_id>
                <issuing_authority>Comitê de Ética em Pesquisa do Setor de Ciências da Saúde da Universidade Federal do Paraná</issuing_authority>    
            </secondary_id>
            
        </secondary_ids>
        <source_support>
            
            <source_name>3M do Brasil - Sumaré, SP, Brazil</source_name>
            
        </source_support>        
    </trial>

</trials>


