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Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of cases before planned changes and the rate of unplanned dressing is significantly associated with the major catheter related infections.
Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease the rate of major catheter related infection as compared to non impregnated dressings and to demonstrate that highly adhesive dressing decrease the rate of detached dressings.
Secondary objectives:
Inclusion criteria: Patients older than 18 years old with central venous who need a central vein and/or an arterial catheter for an expected duration of more than 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegaderm HP | Active Comparator |
| |
| Tegaderm | Placebo Comparator |
| |
| Tegaderm CHG | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaderm, Tegaderm HP, Tegaderm CHG | Procedure | dressings on catheters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel | The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days. | 48 hours after catheter removal or ICU discharge (10 days on average) |
| Measure | Description | Time Frame |
|---|---|---|
| dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm | until catheter removal or ICU discharge (8 days on average) | |
| Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TIMSIT Jean-François, PU/PH | Unit Intensive care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Grenoble | Grenoble | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36645531 | Derived | Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9. | |
| 35799302 |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| 48 hours after catheter removal or ICU discharge (10 days on average) |
| Derived |
| Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x. |
| 32703235 | Derived | Buetti N, Ruckly S, Schwebel C, Mimoz O, Souweine B, Lucet JC, Timsit JF. Chlorhexidine-impregnated sponge versus chlorhexidine gel dressing for short-term intravascular catheters: which one is better? Crit Care. 2020 Jul 23;24(1):458. doi: 10.1186/s13054-020-03174-0. |
| 32643100 | Derived | Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4. |
| 26086783 | Derived | Maunoury F, Motrunich A, Palka-Santini M, Bernatchez SF, Ruckly S, Timsit JF. Cost-Effectiveness Analysis of a Transparent Antimicrobial Dressing for Managing Central Venous and Arterial Catheters in Intensive Care Units. PLoS One. 2015 Jun 18;10(6):e0130439. doi: 10.1371/journal.pone.0130439. eCollection 2015. |
| 24127770 | Derived | Timsit JF, Bouadma L, Mimoz O, Parienti JJ, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Herrault MC, Schwebel C, Ruckly S, Souweine B, Lucet JC. Jugular versus femoral short-term catheterization and risk of infection in intensive care unit patients. Causal analysis of two randomized trials. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1232-9. doi: 10.1164/rccm.201303-0460OC. |
| 23043083 | Derived | Timsit JF, Mimoz O, Mourvillier B, Souweine B, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Lepape A, Vesin A, Arrault X, Schwebel C, Adrie C, Zahar JR, Ruckly S, Tournegros C, Lucet JC. Randomized controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing catheter-related infections in critically ill adults. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1272-8. doi: 10.1164/rccm.201206-1038OC. Epub 2012 Oct 4. |