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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dermatologic Agents
Disinfectants

ClinicalTrials.gov processed this record on October 01, 2014