Clinical Performance of a Chlorhexidine Antimicrobial Dressing

September 30, 2024 updated by: Solventum US LLC
Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Transparent Adhesive Dressing
Standard of Care Non-Antimicrobial Transparent Adhesive Dressing
Drug: Transparent Adhesive Dressing
Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
Other Names:
  • TAD, Polyurethane Dressing, Transparent Membrane Dressing
Experimental: CHG antimicrobial transparent dressing
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Drug: Chlorhexidine gluconate
2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear
Other Names:
  • 3M(TM) Tegaderm(TM) CHG Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Daily up to 7 Days (average 3-7 days of wear)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Overall Satisfaction With Dressing
Time Frame: 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
Daily up to 7 Days (average 3-7 days of wear)
Rating of Skin Condition
Time Frame: 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)
Daily up to 7 Days (average 3-7 days of wear)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

University of Nebraska
3M

Investigators

  • Principal Investigator: Mark E Rupp, M.D., Nebraska Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimated)

August 16, 2007

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-010691

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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