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Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial (CISDCT)

Primary Purpose

Catheter-Related Infections

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
chlorhexidine-gel-impregnated dressing
Polyurethane film dressing
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-Related Infections focused on measuring Bandages, Central Venous Catheters, Catheter-Related Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Clinical Hospital of Ribeirão Preto Medical School (HCFMRP-USP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chlorhexidine-gel-impregnated dressing

Polyurethane film dressing

Arm Description

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

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

Outcomes

Primary Outcome Measures

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With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory.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

Secondary Outcome Measures

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
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.

Full Information

First Posted
January 26, 2015
Last Updated
May 11, 2016
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02472158
Brief Title
Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections
Keywords
Bandages, Central Venous Catheters, Catheter-Related Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chlorhexidine-gel-impregnated dressing
Arm Type
Experimental
Arm Description
Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter
Arm Title
Polyurethane film dressing
Arm Type
Active Comparator
Arm Description
Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.
Intervention Type
Device
Intervention Name(s)
chlorhexidine-gel-impregnated dressing
Other Intervention Name(s)
3M Tegaderm CHG IV securement dressing™
Intervention Description
Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter
Intervention Type
Device
Intervention Name(s)
Polyurethane film dressing
Other Intervention Name(s)
3M Tegaderm IV dressing™
Intervention Description
Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.
Primary Outcome Measure Information:
Title
Catheter Colonization
Description
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
Time Frame
Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.
Secondary Outcome Measure Information:
Title
Microbiological Exit site Infection
Description
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
Time Frame
Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks
Title
Clinical Exit Site Infection
Description
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.
Time Frame
Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Salles Margatho, PhD student
Organizational Affiliation
University of São Paulo at Ribeirão Preto College of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Hospital of Ribeirão Preto Medical School (HCFMRP-USP)
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

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Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

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