Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

Catheter-Related Infections Clinical Trial

— CISDCT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02472158
• Other study ID #: CISD-15
• Status: Active, not recruiting
• Phase: N/A
• First received: January 26, 2015
• Last updated: May 11, 2016
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: September 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter-Related Infections

Intervention

Device:
• chlorhexidine-gel-impregnated dressing
Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter
• Polyurethane film dressing
Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of Ribeirão Preto Medical School (HCFMRP-USP)	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter Colonization	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	Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.	No
Secondary	Microbiological Exit site Infection	With 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	Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks	No
Secondary	Clinical Exit Site Infection	Erythema, 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.	Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks	No