Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-01-31

Brief Summary

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Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing

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Detailed Description

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Prospective, controlled, randomized, clinical trial comparing the 3M™ TegadermTM CHG (Chlorhexidine Gluconate) IV Securement Dressing (3M Healthcare, St Paul, MN) to a standard transparent dressing.

Conditions

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Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transparent Adhesive Dressing

Standard of Care Non-Antimicrobial Transparent Adhesive Dressing

Group Type PLACEBO_COMPARATOR

Transparent Adhesive Dressing

Intervention Type DRUG

Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear

CHG antimicrobial transparent dressing

Chlorhexidine gluconate antimicrobial transparent adhesive dressing

Group Type EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type DRUG

2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear

Interventions

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Chlorhexidine gluconate

2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear

Intervention Type DRUG

Transparent Adhesive Dressing

Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear

Intervention Type DRUG

Other Intervention Names

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3M(TM) Tegaderm(TM) CHG Dressing TAD, Polyurethane Dressing, Transparent Membrane Dressing

Eligibility Criteria

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Inclusion Criteria

* Males or Females over 18 years of age
* Patients with an existing, or newly inserted, central venous catheter
* Patients who require the catheter for at least 3 days