Clinical Performance of a Chlorhexidine Antimicrobial Dressing - Full Text View

Purpose

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

Condition	Intervention	Phase
Catheterization	Drug: Chlorhexidine gluconate Drug: Non-antimicrobial Transparent Adhesive Dressing	Phase II Phase III

ChemIDplus related topics:

Chlorhexidine Chlorhexidine digluconate D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Further study details as provided by 3M:

Primary Outcome Measures:

Clinician Satisfaction [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Enrollment:	63
Study Start Date:	October 2007
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Standard of Care Transparent Adhesive Dressing	Drug: Non-antimicrobial Transparent Adhesive Dressing Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
B: Experimental Chlorhexidine gluconate antimicrobial transparent adhesive dressing	Drug: Chlorhexidine gluconate 2% Chlorheidine Transparetn Dressing applied as needed upto 7 days of wear

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516906

Sponsors and Collaborators

3M

University of Nebraska

Investigators


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

More Information

Responsible Party:	3M Health Care ( JM Heilman; Sr. Clinical Research Specialist )
Study ID Numbers:	05-010691
First Received:	August 14, 2007
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00516906
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Chlorhexidine

Chlorhexidine gluconate

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Infective Agents, Local

Disinfectants

Therapeutic Uses

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	3M University of Nebraska
Information provided by:	3M
ClinicalTrials.gov Identifier:	NCT00516906