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Clinical Performance of a Chlorhexidine Antimicrobial Dressing

This study has been completed.
Sponsor:
Collaborator:
University of Nebraska
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT00516906
First received: August 14, 2007
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Catheterization
 Drug: Chlorhexidine gluconate
Drug: Transparent Adhesive Dressing
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:
  • Clinician Overall Satisfaction With Catheter Securement [ Time Frame: Daily up to 7 Days (average 3-7 days of wear) ] [ Designated as safety issue: Yes ]
    Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor


Secondary Outcome Measures:
  • Clinician Overall Satisfaction With Dressing [ Time Frame: Daily up to 7 Days (average 3-7 days of wear) ] [ Designated as safety issue: No ]
    Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor

  • Rating of Skin Condition [ Time Frame: Daily up to 7 Days (average 3-7 days of wear) ] [ Designated as safety issue: Yes ]
    Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)


Enrollment: 68
Study Start Date: October 2007
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Transparent Adhesive Dressing
Standard of Care Non-Antimicrobial Transparent Adhesive Dressing
 Drug: Transparent Adhesive Dressing
Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
Other Name: TAD, Polyurethane Dressing, Transparent Membrane Dressing
Experimental: CHG antimicrobial transparent dressing
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
 Drug: Chlorhexidine gluconate
2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear
Other Name: 3M(TM) Tegaderm(TM) CHG Dressing

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516906

Sponsors and Collaborators
3M
University of Nebraska
Investigators
Principal Investigator: Mark E Rupp, M.D. Nebraska Medical Center
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00516906     History of Changes
Other Study ID Numbers: 05-010691
Study First Received: August 14, 2007
Results First Received: March 3, 2010
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chlorhexidine gluconate
Anti-Infective Agents
Chlorhexidine
Therapeutic Uses
 Pharmacologic Actions
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013