Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

NCT ID: NCT02472158

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Catheter-Related Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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chlorhexidine-gel-impregnated dressing

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

Group Type EXPERIMENTAL

chlorhexidine-gel-impregnated dressing

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Polyurethane film dressing

Intervention Type DEVICE

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

Interventions

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chlorhexidine-gel-impregnated dressing

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

Intervention Type DEVICE

Polyurethane film dressing

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

Intervention Type DEVICE

Other Intervention Names

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3M Tegaderm CHG IV securement dressing™ 3M Tegaderm IV dressing™

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Amanda Salles Margatho

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda Salles Margatho, PhD student

Role: STUDY_CHAIR

University of São Paulo at Ribeirão Preto College of Nursing

Locations

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

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CISD-15

Identifier Type: -

Identifier Source: org_study_id

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