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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00516906
Other study ID # 05-010691
Secondary ID
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


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
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