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Clinical Performance of a Chlorhexidine Antimicrobial Dressing

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ClinicalTrials.gov Identifier: NCT00516906
Recruitment Status : Completed
First Posted : August 16, 2007
Results First Posted : February 23, 2012
Last Update Posted : August 1, 2012
Sponsor:
Collaborator:
University of Nebraska
Information provided by (Responsible Party):
3M

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

Condition or disease Intervention/treatment Phase
Catheterization Drug: Chlorhexidine gluconate Drug: Transparent Adhesive Dressing Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Performance of a Chlorhexidine Antimicrobial Dressing
Study Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2008


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516906


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

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00516906     History of Changes
Other Study ID Numbers: 05-010691
First Posted: August 16, 2007    Key Record Dates
Results First Posted: February 23, 2012
Last Update Posted: August 1, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Bacterial Agents
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents