Evaluation of dressing for central venous catheter

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7b5ycz
• Date of registration: 26/04/2012
• Primary sponsor: Universidade Federal do Paraná - Curitiba, PR, Brazil
• Public title: Evaluation of dressing for central venous catheter
• Scientific title: Evaluation of the effectiveness of the chlorhexidine antimicrobial dressing for central venous catheter - : ClorHexidine Gluconate-Central Venous Catheter
• Date of first enrolment: 17/10/2011
• Target sample size: 84
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7b5ycz/
• Study design: Preventive, parallel, 2-arms, open, randomized controlled clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Edivane Pedrolo
• Affiliation: Universidade Federal do Paraná

• Name: Edivane Pedrolo
• Affiliation: Universidade Federal do Paraná

Key inclusion & exclusion 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.

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.

Age minimum: 18Y
Age maximum: 100Y
Gender: -

Health Condition(s) or Problem(s) studied

Catheter-related bloodstream infection
C01.539.195

Intervention(s)

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.

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

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.

Secondary ID(s)

CAAE 0067.0.091.208-11

CEP/SD 1145.070.11.06

Source(s) of Monetary Support

3M do Brasil - Sumaré, SP, Brazil

Secondary Sponsor(s)

3M do Brasil - Sumaré, SP, Brazil