NCT02472158

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

January 26, 2015

Last Update Submit

May 11, 2016

Conditions

Catheter-Related Infections

Keywords

BandagesCentral Venous CathetersCatheter-Related Infections

Outcome Measures

Primary Outcomes (1)

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    With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory.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

Secondary Outcomes (2)

  • Microbiological Exit site Infection

    Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks

  • Clinical Exit Site Infection

    Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks

Study Arms (2)

chlorhexidine-gel-impregnated dressing

EXPERIMENTAL

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

Device: chlorhexidine-gel-impregnated dressing

Polyurethane film dressing

ACTIVE COMPARATOR

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

Device: Polyurethane film dressing

Interventions

chlorhexidine-gel-impregnated dressingDEVICE

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

Also known as: 3M Tegaderm CHG IV securement dressing™
chlorhexidine-gel-impregnated dressing
Polyurethane film dressingDEVICE

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

Also known as: 3M Tegaderm IV dressing™
Polyurethane film dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Amanda Salles Margatho, PhD student

    University of São Paulo at Ribeirão Preto College of Nursing

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

January 26, 2015

First Posted

June 15, 2015

Study Start

April 1, 2014

Primary Completion

October 1, 2015

Study Completion

September 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

BR(1)