Trial Outcomes & Findings for Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial Efficacy (NCT NCT04906512)
NCT ID: NCT04906512
Last Updated: 2024-10-16
Results Overview
Rate of CVC tip colonization (positive catheters after culture/total catheters)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
3-14 days
Results posted on
2024-10-16
Participant Flow
After 123 subjects were enrolled and completed all the visits, the study was terminated.
Participant milestones
| Measure |
3M™ Tegaderm™ Transparent Film Dressing 1626W
Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China.
3M™ Tegaderm™ Transparent Film Dressing 1626W: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
|
3M™ Tegaderm™ CHG I.V. Securement Dressing
The primary purpose of 3M™ Tegaderm™ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes.
3M™ Tegaderm™ CHG I.V. Securement Dressing: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
|
Overall Study
COMPLETED
|
39
|
42
|
|
Overall Study
NOT COMPLETED
|
23
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial Efficacy
Baseline characteristics by cohort
| Measure |
3M™ Tegaderm™ CHG I.V. Securement Dressing
n=61 Participants
The primary purpose of 3M™ Tegaderm™ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes.
3M™ Tegaderm™ CHG I.V. Securement Dressing: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
|
3M™ Tegaderm™ Transparent Film Dressing 1626W
n=62 Participants
Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China.
3M™ Tegaderm™ Transparent Film Dressing 1626W: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 16.84 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 12.88 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 14.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
61 participants
n=5 Participants
|
62 participants
n=7 Participants
|
123 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-14 daysPopulation: This endpoint was not collected for all subjects randomized. Also, the study had major protocol deviations that made the available data unreliable.
Rate of CVC tip colonization (positive catheters after culture/total catheters)
Outcome measures
Outcome data not reported
Adverse Events
3M™ Tegaderm™ Transparent Film Dressing 1626W
Serious events: 2 serious events
Other events: 44 other events
Deaths: 2 deaths
3M™ Tegaderm™ CHG I.V. Securement Dressing
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3M™ Tegaderm™ Transparent Film Dressing 1626W
n=62 participants at risk
Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China.
3M™ Tegaderm™ Transparent Film Dressing 1626W: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
|
3M™ Tegaderm™ CHG I.V. Securement Dressing
n=61 participants at risk
The primary purpose of 3M™ Tegaderm™ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes.
3M™ Tegaderm™ CHG I.V. Securement Dressing: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
|
|---|---|---|
|
Vascular disorders
Circulatory collapse
|
1.6%
1/62 • Number of events 1 • 3-14 days
|
0.00%
0/61 • 3-14 days
|
|
Nervous system disorders
Intraventricular hemorrhage
|
1.6%
1/62 • Number of events 1 • 3-14 days
|
0.00%
0/61 • 3-14 days
|
|
Infections and infestations
Sepsis
|
1.6%
1/62 • Number of events 1 • 3-14 days
|
0.00%
0/61 • 3-14 days
|
Other adverse events
| Measure |
3M™ Tegaderm™ Transparent Film Dressing 1626W
n=62 participants at risk
Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China.
3M™ Tegaderm™ Transparent Film Dressing 1626W: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
|
3M™ Tegaderm™ CHG I.V. Securement Dressing
n=61 participants at risk
The primary purpose of 3M™ Tegaderm™ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes.
3M™ Tegaderm™ CHG I.V. Securement Dressing: Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
|
|---|---|---|
|
Investigations
Heart rate increased
|
9.7%
6/62 • 3-14 days
|
8.2%
5/61 • 3-14 days
|
|
General disorders
Pyrexia
|
22.6%
14/62 • 3-14 days
|
24.6%
15/61 • 3-14 days
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
16.1%
10/62 • 3-14 days
|
8.2%
5/61 • 3-14 days
|
|
Vascular disorders
Hypertension
|
8.1%
5/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
3/62 • 3-14 days
|
4.9%
3/61 • 3-14 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.8%
3/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Investigations
Amylase increased
|
4.8%
3/62 • 3-14 days
|
0.00%
0/61 • 3-14 days
|
|
Vascular disorders
Hypotension
|
3.2%
2/62 • 3-14 days
|
4.9%
3/61 • 3-14 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/62 • 3-14 days
|
4.9%
3/61 • 3-14 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/62 • 3-14 days
|
4.9%
3/61 • 3-14 days
|
|
Psychiatric disorders
Delirium
|
0.00%
0/62 • 3-14 days
|
4.9%
3/61 • 3-14 days
|
|
Investigations
Blood bilirubin increased
|
3.2%
2/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Investigations
White blood cell count increased
|
3.2%
2/62 • 3-14 days
|
1.6%
1/61 • 3-14 days
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
2/62 • 3-14 days
|
1.6%
1/61 • 3-14 days
|
|
Investigations
Blood pressure increased
|
3.2%
2/62 • 3-14 days
|
1.6%
1/61 • 3-14 days
|
|
Investigations
Oxygen saturation decreased
|
1.6%
1/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
2/62 • 3-14 days
|
0.00%
0/61 • 3-14 days
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
2/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.6%
1/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
|
Injury, poisoning and procedural complications
Incision site discharge
|
0.00%
0/62 • 3-14 days
|
3.3%
2/61 • 3-14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place