Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Catheterization Clinical Trial

Official title:

Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516906
• Other study ID #: 05-010691
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 14, 2007
• Last updated: July 25, 2012
• Start date: October 2007
• Est. completion date: January 2008

Study information

• Verified date: July 2012
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheterization

Intervention

Drug:
• Chlorhexidine gluconate
2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear
• Transparent Adhesive Dressing
Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
3M	University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Overall Satisfaction With Catheter Securement	Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor	Daily up to 7 Days (average 3-7 days of wear)	Yes
Secondary	Clinician Overall Satisfaction With Dressing	Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor	Daily up to 7 Days (average 3-7 days of wear)	No
Secondary	Rating of Skin Condition	Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)	Daily up to 7 Days (average 3-7 days of wear)	Yes