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Clinical Trials/NCT00516906
NCT00516906CompletedPhase 2

Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Solventum US LLC0 sites68 target enrollmentStarted: October 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
68
Primary Endpoint
Clinician Overall Satisfaction With Catheter Securement
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Transparent Adhesive Dressing

Placebo Comparator

Standard of Care Non-Antimicrobial Transparent Adhesive Dressing

Intervention: Transparent Adhesive Dressing (Drug)

CHG antimicrobial transparent dressing

Experimental

Chlorhexidine gluconate antimicrobial transparent adhesive dressing

Intervention: Chlorhexidine gluconate (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Clinician Overall Satisfaction With Dressing(Daily up to 7 Days (average 3-7 days of wear))
  • Rating of Skin Condition(Daily up to 7 Days (average 3-7 days of wear))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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Clinical Performance of a Chlorhexidine... | Clinical Trial