Catheterization
Conditions
Brief summary
Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing
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.
Interventions
DRUGChlorhexidine gluconate
2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear
DRUGTransparent Adhesive Dressing
Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
Sponsors
University of Nebraska
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
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 details
No Wash out. No run-in
Participants by arm
| Arm | Count |
|---|---|
| Placebo Comparator: A Standard of Care Transparent Adhesive Dressing | 36 |
| CHG Antimicrobial Transparent Dressing Chlorhexidine gluconate antimicrobial transparent adhesive dressing | 32 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Final Dressing Removal Data not captured | 6 | 2 |
Baseline characteristics
| Characteristic | CHG Antimicrobial Transparent Dressing | Placebo Comparator: A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 12 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 24 Participants | 45 Participants |
| Age, Continuous | 53.4 years STANDARD_DEVIATION 18.5 | 58.7 years STANDARD_DEVIATION 15.1 | 56.0 years STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 32 participants | 36 participants | 68 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 30 | 2 / 30 |
| serious Total, serious adverse events | 1 / 30 | 3 / 30 |
Outcome results
Primary
Clinician Overall Satisfaction With Catheter Securement
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Comparator: A | Clinician Overall Satisfaction With Catheter Securement | 2.27 Units on a scale | Standard Deviation 0.78 |
| CHG Antimicrobial Transparent Dressing | Clinician Overall Satisfaction With Catheter Securement | 1.63 Units on a scale | Standard Deviation 1.63 |
Secondary
Clinician Overall Satisfaction With Dressing
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Comparator: A | Clinician Overall Satisfaction With Dressing | 2.20 Units on a scale | Standard Deviation 0.81 |
| CHG Antimicrobial Transparent Dressing | Clinician Overall Satisfaction With Dressing | 1.63 Units on a scale | Standard Deviation 0.61 |
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)
Time frame: Daily up to 7 Days (average 3-7 days of wear)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Comparator: A | Rating of Skin Condition | 0.1 Units on a scale | Standard Deviation 0.29 |
| CHG Antimicrobial Transparent Dressing | Rating of Skin Condition | 0.2 Units on a scale | Standard Deviation 0.33 |