Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Phase 2

Completed

• Conditions: Catheterization
• Interventions: Drug: Transparent Adhesive Dressing; Drug: Chlorhexidine gluconate

• Registration Number: NCT00516906
• Lead Sponsor: Solventum US LLC

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 Timeline

• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-16
• Study Start: 2007-10
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Results First Submitted: 2010-03-03
• Results First Submitted QC: 2012-01-20
• Results First Posted: 2012-02-23
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transparent Adhesive Dressing	Transparent Adhesive Dressing	Standard of Care Non-Antimicrobial Transparent Adhesive Dressing
CHG antimicrobial transparent dressing	Chlorhexidine gluconate	Chlorhexidine gluconate antimicrobial transparent adhesive dressing

Primary Outcome Measures

Name	Time	Method
Clinician Overall Satisfaction With Catheter Securement	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

Name	Time	Method
Clinician Overall Satisfaction With Dressing	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
Rating of Skin Condition	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)