Trial Outcomes & Findings for Clinical Performance of a Chlorhexidine Antimicrobial Dressing (NCT NCT00516906)
NCT ID: NCT00516906
Last Updated: 2024-10-24
Results Overview
Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
68 participants
Primary outcome timeframe
Daily up to 7 Days (average 3-7 days of wear)
Results posted on
2024-10-24
Participant Flow
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
No Wash out. No run-in
Participant milestones
| Measure |
Placebo Comparator: A
Standard of Care Transparent Adhesive Dressing
|
CHG Antimicrobial Transparent Dressing
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
32
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Placebo Comparator: A
Standard of Care Transparent Adhesive Dressing
|
CHG Antimicrobial Transparent Dressing
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
|
|---|---|---|
|
Overall Study
Final Dressing Removal Data not captured
|
6
|
2
|
Baseline Characteristics
Clinical Performance of a Chlorhexidine Antimicrobial Dressing
Baseline characteristics by cohort
| Measure |
Placebo Comparator: A
n=36 Participants
Standard of Care Transparent Adhesive Dressing
|
CHG Antimicrobial Transparent Dressing
n=32 Participants
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
53.4 years
STANDARD_DEVIATION 18.5 • n=107 Participants
|
56.0 years
STANDARD_DEVIATION 17.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=99 Participants
|
32 participants
n=107 Participants
|
68 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Placebo Comparator: A
n=30 Participants
Standard of Care Transparent Adhesive Dressing
|
CHG Antimicrobial Transparent Dressing
n=30 Participants
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
|
|---|---|---|
|
Clinician Overall Satisfaction With Catheter Securement
|
2.27 Units on a scale
Standard Deviation 0.78
|
1.63 Units on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Placebo Comparator: A
n=30 Participants
Standard of Care Transparent Adhesive Dressing
|
CHG Antimicrobial Transparent Dressing
n=30 Participants
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
|
|---|---|---|
|
Clinician Overall Satisfaction With Dressing
|
2.20 Units on a scale
Standard Deviation 0.81
|
1.63 Units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Placebo Comparator: A
n=30 Participants
Standard of Care Transparent Adhesive Dressing
|
CHG Antimicrobial Transparent Dressing
n=30 Participants
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
|
|---|---|---|
|
Rating of Skin Condition
|
0.1 Units on a scale
Standard Deviation 0.29
|
0.2 Units on a scale
Standard Deviation 0.33
|
Adverse Events
Placebo Comparator: A
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
CHG Antimicrobial Transparent Dressing
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Comparator: A
n=30 participants at risk
Standard of Care Transparent Adhesive Dressing
|
CHG Antimicrobial Transparent Dressing
n=30 participants at risk
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to underlying Disease
|
3.3%
1/30 • Number of events 1 • 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
|
10.0%
3/30 • Number of events 3 • 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
|
Other adverse events
| Measure |
Placebo Comparator: A
n=30 participants at risk
Standard of Care Transparent Adhesive Dressing
|
CHG Antimicrobial Transparent Dressing
n=30 participants at risk
Chlorhexidine gluconate antimicrobial transparent adhesive dressing
|
|---|---|---|
|
General disorders
Elevated Temperature
|
3.3%
1/30 • Number of events 1 • 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
|
3.3%
1/30 • Number of events 1 • 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
|
|
Infections and infestations
Elevated WBC, No fever, culture negative
|
3.3%
1/30 • Number of events 1 • 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
|
0.00%
0/30 • 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
|
|
Psychiatric disorders
Intermittent confusion existing prior to start
|
0.00%
0/30 • 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
|
3.3%
1/30 • Number of events 1 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place