Clinical Performance of a Chlorhexidine Antimicrobial Dressing

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00516906
• Collaborator: University of Nebraska (Other)
• Enrollment: 68
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Catheterization	Drug: Chlorhexidine gluconate; Drug: Transparent Adhesive Dressing	Phase 2/Phase 3

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
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Performance of a Chlorhexidine Antimicrobial Dressing
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• 3M
• University of Nebraska

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT00516906
• Other Study ID Numbers: 05-010691
• First Posted: Aug 16, 2007
• Last Update Posted: Aug 1, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Chlorhexidine; Chlorhexidine gluconate

Study Results

Participant Flow

Recruitment Details	The study population included adult males and female patients with an existing, or newly inserted, catheter that was to remain in place for at least 3 days, who were willing to participate in the study, and who would provide informed consent and sign a consent form. First patient enrolled 10 October 2007. Last patient enrolled 20 December 2007
Pre-assignment Detail	No Wash out. No run-in

Arm/Group Title	Placebo Comparator: A	CHG Antimicrobial Transparent Dressing
Arm/Group Description	Standard of Care Transparent Adhesive Dressing	Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Period Title: Overall Study
STARTED	36	32
COMPLETED	30	30
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	Placebo Comparator: A	CHG Antimicrobial Transparent Dressing	Total
Arm/Group Description	Standard of Care Transparent Adhesive Dressing	Chlorhexidine gluconate antimicrobial transparent adhesive dressing	Total of all reporting groups
Overall Participants	36	32	68
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 66.7%	21 65.6%	45 66.2%
>=65 years	12 33.3%	11 34.4%	23 33.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.7 (15.1)	53.4 (18.5)	56.0 (17.0)
Sex: Female, Male (Count of Participants)
Female	20 55.6%	20 62.5%	40 58.8%
Male	16 44.4%	12 37.5%	28 41.2%
Region of Enrollment (participants) [Number]
United States	36 100%	32 100%	68 100%

Outcome Measures

1. Primary Outcome

Title	Clinician Overall Satisfaction With Catheter Securement
Description	Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor
Time Frame	Daily up to 7 Days (average 3-7 days of wear)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Comparator: A	CHG Antimicrobial Transparent Dressing
Arm/Group Description	Standard of Care Transparent Adhesive Dressing	Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Measure Participants	30	30
Mean (Standard Deviation) [Units on a scale]	2.27 (0.78)	1.63 (1.63)

2. Secondary Outcome

Title	Clinician Overall Satisfaction With Dressing
Description	Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor
Time Frame	Daily up to 7 Days (average 3-7 days of wear)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Comparator: A	CHG Antimicrobial Transparent Dressing
Arm/Group Description	Standard of Care Transparent Adhesive Dressing	Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Measure Participants	30	30
Mean (Standard Deviation) [Units on a scale]	2.20 (0.81)	1.63 (0.61)

3. Secondary Outcome

Title	Rating of Skin Condition
Description	Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)
Time Frame	Daily up to 7 Days (average 3-7 days of wear)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Comparator: A	CHG Antimicrobial Transparent Dressing
Arm/Group Description	Standard of Care Transparent Adhesive Dressing	Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Measure Participants	30	30
Mean (Standard Deviation) [Units on a scale]	0.1 (0.29)	0.2 (0.33)

Adverse Events

Time Frame	The study ran 3 months (10 October 2008- 20 December 2008) The maximum length of exposure of each patient to the dressings was 7.1 days.
Adverse Event Reporting Description	The insertion site was evaluated each day by study personnel and patients were asked about their well being
Arm/Group Title	Placebo Comparator: A		CHG Antimicrobial Transparent Dressing
Arm/Group Description	Standard of Care Transparent Adhesive Dressing		Chlorhexidine gluconate antimicrobial transparent adhesive dressing
All Cause Mortality
	Placebo Comparator: A		CHG Antimicrobial Transparent Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Comparator: A		CHG Antimicrobial Transparent Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)		3/30 (10%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to underlying Disease	1/30 (3.3%)	1	3/30 (10%)	3
Other (Not Including Serious) Adverse Events
	Placebo Comparator: A		CHG Antimicrobial Transparent Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/30 (6.7%)		2/30 (6.7%)
General disorders
Elevated Temperature	1/30 (3.3%)	1	1/30 (3.3%)	1
Infections and infestations
Elevated WBC, No fever, culture negative	1/30 (3.3%)	1	0/30 (0%)	0
Psychiatric disorders
Intermittent confusion existing prior to start	0/30 (0%)	0	1/30 (3.3%)	1

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.