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| Name | Class |
|---|---|
| Hospitales Universitarios Virgen del Rocío | OTHER |
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Randomised, single-blind clinical trial comparing chlorhexidine gluconate-impregnated transparent dressings versus conventional transparent dressings in the prevention of central venous catheter-related bloodstream infections (CVC-BSI) in paediatric patients admitted to a tertiary hospital PICU. Outcomes include incidence of BRCVC, catheter colonisation, dressing-related skin complications, and number of dressing changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental - Chlorhexidine gluconate-impregnated dressing | Experimental | Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site. |
|
| Control - Conventional transparent dressing | Active Comparator | Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of central venous catheter-related bloodstream infection (CVC-BSI) | CVC-BSI confirmed by clinical signs and positive blood culture according to Bacteriemia Zero protocol. | Baseline to 4 weeks or until catheter removal |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter colonisation rate | Positive culture of catheter tip (>15 CFU/mL) according to standard microbiological protocol. | At catheter removal (up to 14 days after insertion) |
| Skin complications at insertion site |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Pabón-Carrasco | Contact | +34 669709548 | mpabon2@us.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocío - Hospital Infantil | Recruiting | Seville | Sevilla | 41004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42102647 | Derived | Portero-Prados FJ, Pabon-Carrasco M, Ponce-Blandon JA. Effectiveness of chlorhexidine gluconate-impregnated dressings in preventing central line-associated bloodstream infection in a paediatric intensive care unit: A randomised controlled trial. Intensive Crit Care Nurs. 2026 May 7;96:104441. doi: 10.1016/j.iccn.2026.104441. Online ahead of print. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 27, 2026 | |
| Reset | May 19, 2026 | |
| Release | Jun 14, 2026 |
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This was a single-blind trial. The outcomes assessor was blinded to group allocation. Participants and care providers were aware of the dressing used
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| Conventional transparent polyurethane dressing | Device | 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. |
|
Erythema, pruritus or dermatitis at the catheter insertion site documented by clinical observation.
| Up to 4 weeks |
| Number of dressing changes per patient | Total number of dressing replacements per patient recorded during catheterisation. | Up to 4 weeks |
| Reset | Jul 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2026 | May 19, 2026 | |||
| Jun 14, 2026 | Jul 9, 2026 | |||
| Jul 9, 2026 |
| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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