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| Name | Class |
|---|---|
| University of Nebraska | OTHER |
| 3M | INDUSTRY |
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Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transparent Adhesive Dressing | Placebo Comparator | Standard of Care Non-Antimicrobial Transparent Adhesive Dressing |
|
| CHG antimicrobial transparent dressing | Experimental | Chlorhexidine gluconate antimicrobial transparent adhesive dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate | Drug | 2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Overall Satisfaction With Dressing | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark E Rupp, M.D. | Nebraska Medical Center | Principal Investigator |
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No Wash out. No run-in
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Comparator: A | Standard of Care Transparent Adhesive Dressing |
| FG001 | CHG Antimicrobial Transparent Dressing | Chlorhexidine gluconate antimicrobial transparent adhesive dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Comparator: A | Standard of Care Transparent Adhesive Dressing |
| BG001 | CHG Antimicrobial Transparent Dressing | Chlorhexidine gluconate antimicrobial transparent adhesive dressing |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician Overall Satisfaction With Catheter Securement | Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor | Posted | Jan 2009 | Mean | Standard Deviation | Units on a scale | Daily up to 7 Days (average 3-7 days of wear) |
|
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.
The insertion site was evaluated each day by study personnel and patients were asked about their well being
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Comparator: A | Standard of Care Transparent Adhesive Dressing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to underlying Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Other: AE table | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Temperature | General disorders | Other: AE table | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J M Heilman | 3M | 651-733-9897 | jmheilman@mmm.com |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| C039418 | DAT protocol 1 |
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| Transparent Adhesive Dressing | Drug | Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Clinician Overall Satisfaction With Dressing | Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor | Posted | Mean | Standard Deviation | Units on a scale | Daily up to 7 Days (average 3-7 days of wear) |
|
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| Secondary | Rating of Skin Condition | Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe) | Posted | Jan 2009 | Mean | Standard Deviation | Units on a scale | Daily up to 7 Days (average 3-7 days of wear) |
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| 1 |
| 30 |
| 2 |
| 30 |
| EG001 | CHG Antimicrobial Transparent Dressing | Chlorhexidine gluconate antimicrobial transparent adhesive dressing | 3 | 30 | 2 | 30 |
| Elevated WBC, No fever, culture negative | Infections and infestations | Other: AE table | Systematic Assessment |
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| Intermittent confusion existing prior to start | Psychiatric disorders | Other: AE table | Systematic Assessment |
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