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Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

Use of Chlorhexidine-gel-Impregnated Dressing Compared to Transparent Polyurethane Film Dressing as Coverage of the Site of Insertion of Central Venous Catheter, in the Evaluation of Catheter Colonization in Critically Ill Adults Patients: A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02472158
Acronym
CISDCT
Enrollment
120
Registered
2015-06-15
Start date
2014-04-30
Completion date
2016-09-30
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-Related Infections

Keywords

Bandages, Central Venous Catheters, Catheter-Related Infections

Brief summary

The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients.

Interventions

DEVICEchlorhexidine-gel-impregnated dressing

Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter

DEVICEPolyurethane film dressing

Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Critically ill patients hospitalized carrying a short-term central venous catheter

Exclusion criteria

* Use of a central venous catheter with antimicrobial coating * Suspected or confirmed bacterial infection at randomization * Known allergic/hypersensitivity reaction to any compounds of the treatment * Active lesions in the skin where the CVC is located and / or where the dressing of CVC is being conducted;

Design outcomes

Primary

MeasureTime frameDescription
Catheter ColonizationParticipants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Catheter Colonization a significant growth of one or more microorganism in a semiquantitative culture of the catheter tip. It is according to the Clinical Practice Guidelines for the Diagnosis and management of Intravascular Catheter- Related Infection: 2009 Update by the Infectious Diseases Society of America

Secondary

MeasureTime frameDescription
Clinical Exit Site InfectionParticipants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeksErythema, induration, and/or tenderness within 2 cm of the catheter exit site, according to Clinical Practice Guidelines for the diagnosis and management of intravascular Catheter-Related Infection: 2009 Update by the infectious diseases Society of America.
Microbiological Exit site InfectionParticipants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeksWith aseptic technique, a swab will be collected before removal of central venous catheter, the swab will be moistened with sterile saline and rolled for about 2 cm around the exit site. The material will be conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Microbiological Exit Site Infection the exudate at catheter exit site yields a microorganism. According to Clinical Practice Guideline for Diagnosis and Management of intravascular Catheter-Related Infection: 2009 Update by the Infectious Diseases Society of America

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026