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OpenTrials
Completed

NCT Number: NCT00516906

Clinical Performance of a Chlorhexidine Antimicrobial Dressing

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

Completed

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Key information

Conditions

Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate

Drug

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

Other names: 3M(TM) Tegaderm(TM) CHG Dressing

Transparent Adhesive Dressing

Drug

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

Other names: TAD, Polyurethane Dressing, Transparent Membrane Dressing

Primary outcomes

  1. Clinician Overall Satisfaction With Catheter Securement

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

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

Secondary outcomes

  1. Clinician Overall Satisfaction With Dressing

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

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

  2. Rating of Skin Condition

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

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

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M
  • University of Nebraska

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Aug 16, 2007
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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