Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Solventum US LLC68 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Catheterization

Interventions

Chlorhexidine gluconateDRUG

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

Transparent Adhesive DressingDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Sensitivity to chlorhexidine

Outcomes

Primary Outcomes

Clinician Overall Satisfaction With Catheter Securement

Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor

Time frame: Daily up to 7 Days (average 3-7 days of wear)

Secondary Outcomes

Clinician Overall Satisfaction With Dressing

Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor

Time frame: Daily up to 7 Days (average 3-7 days of wear)

Rating of Skin Condition

Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)

Time frame: Daily up to 7 Days (average 3-7 days of wear)

Data from ClinicalTrials.gov

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