Clinical Performance of a Chlorhexidine Antimicrobial Dressing

NCT00516906 | Completed Phase 2 Results

• 1 other identifier: 05-010691
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Catheterization

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 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)

Study Arms (2)

Transparent Adhesive Dressing

PLACEBO COMPARATOR

Standard of Care Non-Antimicrobial Transparent Adhesive Dressing

Drug: Transparent Adhesive Dressing

CHG antimicrobial transparent dressing

EXPERIMENTAL

Chlorhexidine gluconate antimicrobial transparent adhesive dressing

Drug: Chlorhexidine gluconate

Interventions

Chlorhexidine gluconate DRUG

2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear

Also known as: 3M(TM) Tegaderm(TM) CHG Dressing

CHG antimicrobial transparent dressing

Transparent Adhesive Dressing DRUG

Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear

Also known as: TAD, Polyurethane Dressing, Transparent Membrane Dressing

Transparent Adhesive Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Sensitivity to chlorhexidine

Sponsors & Collaborators

• Solventum US LLC: lead
• University of Nebraska: collaborator
• 3M: collaborator

MeSH Terms

Interventions

chlorhexidine gluconate; DAT protocol 1

Limitations and Caveats

This trial evaluated the dressing for it's securement and ease of use adaption into healthcare practices compared to a standard transparent dressing. The sample size was too small to evaluate any effect on Catheter Related-Bloodstream Infection.

Results Point of Contact

• Title: J M Heilman
• Organization: 3M

jmheilman@mmm.com

651-733-9897

Study Officials

• Mark E Rupp, M.D.

  Nebraska Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 16, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2008
• Last Updated: October 24, 2024
• Results First Posted: February 23, 2012

Record last verified: 2024-09