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Clinical Performance of a Chlorhexidine Antimicrobial Dressing

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ClinicalTrials.gov Identifier: NCT00516906
Recruitment Status : Completed
First Posted : August 16, 2007
Results First Posted : February 23, 2012
Last Update Posted : August 1, 2012
Sponsor:
Collaborator:
University of Nebraska
Information provided by (Responsible Party):
3M

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Catheterization
Interventions Drug: Chlorhexidine gluconate
Drug: Transparent Adhesive Dressing
Enrollment 68
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 Details No Wash out. No run-in
Arm/Group Title Placebo Comparator: A CHG Antimicrobial Transparent Dressing
Hide Arm/Group Description Standard of Care Transparent Adhesive Dressing Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Period Title: Overall Study
Started 36 32 [1]
Completed 30 [2] 30 [2]
Not Completed 6 2
Reason Not Completed
Final Dressing Removal Data not captured             6             2
[1]
33 patients were randomized but one patient was discharged prior to treatment.
[2]
Thirty patients were required to complete. Patients not completing were replaced.
Arm/Group Title Placebo Comparator: A CHG Antimicrobial Transparent Dressing Total
Hide Arm/Group Description Standard of Care Transparent Adhesive Dressing Chlorhexidine gluconate antimicrobial transparent adhesive dressing Total of all reporting groups
Overall Number of Baseline Participants 36 32 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
<=18 years
0
   0.0%
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 Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 32 participants 68 participants
58.7  (15.1) 53.4  (18.5) 56.0  (17.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
Female
20
  55.6%
20
  62.5%
40
  58.8%
Male
16
  44.4%
12
  37.5%
28
  41.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 32 participants 68 participants
36 32 68
1.Primary Outcome
Title Clinician Overall Satisfaction With Catheter Securement
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Comparator: A CHG Antimicrobial Transparent Dressing
Hide Arm/Group Description:
Standard of Care Transparent Adhesive Dressing
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.27  (0.78) 1.63  (1.63)
2.Secondary Outcome
Title Clinician Overall Satisfaction With Dressing
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Comparator: A CHG Antimicrobial Transparent Dressing
Hide Arm/Group Description:
Standard of Care Transparent Adhesive Dressing
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.20  (0.81) 1.63  (0.61)
3.Secondary Outcome
Title Rating of Skin Condition
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Comparator: A CHG Antimicrobial Transparent Dressing
Hide Arm/Group Description:
Standard of Care Transparent Adhesive Dressing
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.1  (0.29) 0.2  (0.33)
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Comparator: A CHG Antimicrobial Transparent Dressing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      3/30 (10.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death due to underlying Disease  1  1/30 (3.33%)  1 3/30 (10.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, Other: AE table
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Comparator: A CHG Antimicrobial Transparent Dressing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/30 (6.67%)      2/30 (6.67%)    
General disorders     
Elevated Temperature  1  1/30 (3.33%)  1 1/30 (3.33%)  1
Infections and infestations     
Elevated WBC, No fever, culture negative  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Psychiatric disorders     
Intermittent confusion existing prior to start  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Other: AE table
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.
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.
Results Point of Contact
Name/Title: J M Heilman
Organization: 3M
Phone: 651-733-9897
Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00516906     History of Changes
Other Study ID Numbers: 05-010691
First Submitted: August 14, 2007
First Posted: August 16, 2007
Results First Submitted: March 3, 2010
Results First Posted: February 23, 2012
Last Update Posted: August 1, 2012