Trial Outcomes & Findings for Advanced Dressings for CVC Infection Prevention in PICU (NCT NCT07175116)
NCT ID: NCT07175116
Last Updated: 2026-07-13
Results Overview
Participants who developed central venous catheter-related bloodstream infection (CVC-BSI), confirmed according to the Bacteriemia Zero protocol based on clinical signs and positive blood culture findings during follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
From catheter insertion to 4 weeks or until catheter removal
Results posted on
2026-07-13
Participant Flow
Participant milestones
| Measure |
Experimental - Chlorhexidine Gluconate-impregnated Dressing
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated): Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.
|
Control - Conventional Transparent Dressing
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Conventional transparent polyurethane dressing: Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
125
|
|
Overall Study
COMPLETED
|
125
|
125
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental - Chlorhexidine Gluconate-impregnated Dressing
n=125 Participants
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated): Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.
|
Control - Conventional Transparent Dressing
n=125 Participants
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Conventional transparent polyurethane dressing: Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 months
STANDARD_DEVIATION 60.7 • n=125 Participants
|
56.6 months
STANDARD_DEVIATION 71.9 • n=125 Participants
|
56.6 months
STANDARD_DEVIATION 55.1 • n=250 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=125 Participants
|
54 Participants
n=125 Participants
|
111 Participants
n=250 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=125 Participants
|
71 Participants
n=125 Participants
|
139 Participants
n=250 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
125 participants
n=125 Participants
|
125 participants
n=125 Participants
|
250 participants
n=250 Participants
|
|
Catheter type (PICC / CICC)
PICC
|
97 participants
n=125 Participants
|
40 participants
n=125 Participants
|
137 participants
n=250 Participants
|
|
Catheter type (PICC / CICC)
CICC
|
28 participants
n=125 Participants
|
85 participants
n=125 Participants
|
113 participants
n=250 Participants
|
PRIMARY outcome
Timeframe: From catheter insertion to 4 weeks or until catheter removalParticipants who developed central venous catheter-related bloodstream infection (CVC-BSI), confirmed according to the Bacteriemia Zero protocol based on clinical signs and positive blood culture findings during follow-up.
Outcome measures
| Measure |
Experimental - Chlorhexidine Gluconate-impregnated Dressing
n=125 Participants
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated): Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.
|
Control - Conventional Transparent Dressing
n=125 Participants
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Conventional transparent polyurethane dressing: Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.
|
|---|---|---|
|
Number of Participants With Central Venous Catheter-Related Bloodstream Infection (CVC-BSI)
|
3 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At catheter removal (up to 14 days after insertion)Population: All randomised participants were included in the outcome analysis (intention-to-treat population).
Positive culture of catheter tip (\>15 CFU/mL) according to standard microbiological protocol.
Outcome measures
| Measure |
Experimental - Chlorhexidine Gluconate-impregnated Dressing
n=125 Participants
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated): Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.
|
Control - Conventional Transparent Dressing
n=125 Participants
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Conventional transparent polyurethane dressing: Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.
|
|---|---|---|
|
Catheter Colonisation Rate
|
3 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeksErythema, pruritus or dermatitis at the catheter insertion site documented by clinical observation.
Outcome measures
| Measure |
Experimental - Chlorhexidine Gluconate-impregnated Dressing
n=125 Participants
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated): Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.
|
Control - Conventional Transparent Dressing
n=125 Participants
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Conventional transparent polyurethane dressing: Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.
|
|---|---|---|
|
Skin Complications at Insertion Site
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeksTotal number of dressing replacements per patient recorded during catheterisation.
Outcome measures
| Measure |
Experimental - Chlorhexidine Gluconate-impregnated Dressing
n=125 Participants
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated): Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.
|
Control - Conventional Transparent Dressing
n=125 Participants
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Conventional transparent polyurethane dressing: Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.
|
|---|---|---|
|
Number of Dressing Changes Per Patient
|
1.8 changes per patient
Standard Deviation 0.8
|
2.1 changes per patient
Standard Deviation 1.4
|
Adverse Events
Experimental - Chlorhexidine Gluconate-impregnated Dressing
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Control - Conventional Transparent Dressing
Serious events: 23 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental - Chlorhexidine Gluconate-impregnated Dressing
n=125 participants at risk
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated): Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.
|
Control - Conventional Transparent Dressing
n=125 participants at risk
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Conventional transparent polyurethane dressing: Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.
|
|---|---|---|
|
Infections and infestations
Catheter-related bloodstream infection (CLABSI)
|
2.4%
3/125 • Number of events 3 • From catheter insertion until catheter removal or up to 4 weeks follow-up.
Adverse events were prospectively collected during the catheterisation period through clinical observation and microbiological assessment. Catheter-related bloodstream infections were defined according to standard diagnostic criteria. Skin complications (e.g., erythema, pruritus, dermatitis) were recorded based on clinical assessment at the insertion site.
|
18.4%
23/125 • Number of events 23 • From catheter insertion until catheter removal or up to 4 weeks follow-up.
Adverse events were prospectively collected during the catheterisation period through clinical observation and microbiological assessment. Catheter-related bloodstream infections were defined according to standard diagnostic criteria. Skin complications (e.g., erythema, pruritus, dermatitis) were recorded based on clinical assessment at the insertion site.
|
Other adverse events
| Measure |
Experimental - Chlorhexidine Gluconate-impregnated Dressing
n=125 participants at risk
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated): Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.
|
Control - Conventional Transparent Dressing
n=125 participants at risk
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Conventional transparent polyurethane dressing: Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
16.8%
21/125 • Number of events 21 • From catheter insertion until catheter removal or up to 4 weeks follow-up.
Adverse events were prospectively collected during the catheterisation period through clinical observation and microbiological assessment. Catheter-related bloodstream infections were defined according to standard diagnostic criteria. Skin complications (e.g., erythema, pruritus, dermatitis) were recorded based on clinical assessment at the insertion site.
|
11.2%
14/125 • Number of events 14 • From catheter insertion until catheter removal or up to 4 weeks follow-up.
Adverse events were prospectively collected during the catheterisation period through clinical observation and microbiological assessment. Catheter-related bloodstream infections were defined according to standard diagnostic criteria. Skin complications (e.g., erythema, pruritus, dermatitis) were recorded based on clinical assessment at the insertion site.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place