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Clinical Performance of a Chlorhexidine Antimicrobial Dressing
This study has been completed.
First Received: August 14, 2007   Last Updated: May 29, 2008   History of Changes
Sponsor: 3M
Collaborator: University of Nebraska
Information provided by: 3M
ClinicalTrials.gov Identifier: NCT00516906
  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: Non-antimicrobial Transparent Adhesive Dressing
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • Clinician Satisfaction [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Enrollment: 63
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
A: Placebo Comparator
Standard of Care Transparent Adhesive Dressing
Drug: Non-antimicrobial Transparent Adhesive Dressing
Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
B: Experimental
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Drug: Chlorhexidine gluconate
2% Chlorheidine Transparetn Dressing applied as needed upto 7 days of wear

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 Health Care ( JM Heilman; Sr. Clinical Research Specialist )
Study ID Numbers: 05-010691
Study First Received: August 14, 2007
Last Updated: May 29, 2008
ClinicalTrials.gov Identifier: NCT00516906     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 04, 2010