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| Name | Class |
|---|---|
| University Hospital, Montpellier | OTHER |
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Peripherally Inserted Central Catheters have been widely used for many years for the administration of chemotherapy to patients with cancer. However, its use entails significant infectious complications and high risks of death.The hypothesis is that increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.
The PICCline ("Peripherally Inserted Central Catheter") is a central catheter whose brachial insertion is peripheral. It has been widely used for many years for the administration of chemotherapy to patients with cancer. Although its use is growing (2.7 million applications in the USA in 2020), significant infectious complications (especially bacteremia) and even high risks of death are generally associated with it.
In December 2013, the French Society of Hospital Hygiene (SF2H) published a guide of "Recommendations for good practices and management of risks associated with PICC" to help professionals in the use of this device. It states that the rate of dressing repair is set at a maximum of 8 days for a sterile semipermeable transparent dressing; however, this recommendation is based on a questionable level of evidence (grade E level of evidence according to the HAS). In the appendix to this guide, the analysis of the scientific literature does not highlight any articles comparing different dressing repair rates. An observational study was conducted at the University Hospital of Nîmes, in order to determine the rate of infection on PICCline in the Hematology Department. In 2019, out of the 90 PICClines applied (dressing changes every 2 days), 12 infections (local and/or systemic) were noted, i.e. 13.3%.
In order to know the current practices of the different hematology services in France, a survey was conducted to collect protocols for PICCline dressing changes. A total of 23 haematology departments were contacted, 18 of which responded. The observation was made that, although most departments respected the SF2H recommendation (15 out of 18), others proposed different rhythms of care: (a) in the Hematology department at Nîmes University Hospital, dressings are redone every 48 hours, (b) in Montpellier, the frequency was 2 to 3 times a week, (c) in Grenoble, the use of PICCline was abandoned by the medical team who noted too many infections and thromboses associated with this device, and (d) in Toulouse and Strasbourg, the PICCline was used less and less for these same reasons. Moreover, the SF2H recommendations are addressed in a general way to professionals and valid for all patients; but no study can currently affirm that they are applicable to a fragile population of immunocompromised patients in the context of intensive chemotherapy. Hematology patients have a high risk of febrile neutropenia, of around 80%, and this risk of immunosuppression is a non-negligible point in terms of infection prevention during patient management.
In 2019 in France, the Réseau de Prévention des Infections Associées aux Soins launched a campaign to monitor and prevent infections associated with invasive devices. For 3 months, data on the occurrence of infectious episodes were collected in 1001 healthcare facilities. Of the nearly 12,000 bacteremia episodes identified, 25.4% were associated with an intravascular device, 17% of which were PICCline. Moreover, the survey revealed that the highest rates of occurrence were found in the Intensive Care Unit, Oncology and Hematology departments and the prevalence of bacteremia associated with intravascular devices in Hematology represented 39.8%.
Hypothesis : increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Patients receiving normal management with dressings changed once a week according to the SF2H recommendations. |
|
| Experimental group | Experimental | Patients whose dressings are changed every other day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dressing change | Other | The patient circuit corresponds to that of usual care. Not part of usual patient management:
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 1+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 9+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 17+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain or discomfort generated by PICCline dressing changes in controls | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 1 |
| Pain or discomfort generated by PICCline dressing changes in controls |
| Measure | Description | Time Frame |
|---|---|---|
| Age of patients in the control group | In years | At the inclusion visit (- 48 hours to Day 0) |
| Age of patients in the experimental group | In years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Éric JOURDAN, Dr. | Contact | +334.66.68.32.34 | Eric.jourdan@chu-nimes.fr | |
| Anissa MEGZARI | Contact | +33466684236 | drc@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julie LASSALLE, Mme. | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier Hôpital St-Eloi | Recruiting | Montpellier | 34090 | France |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Prospective two-center randomized open-label controlled pilot study in two parallel groups according to PICCline dressing repair: (i) Control group (every 8 days, see SF2H recommendations), (ii) Experimental group (every 2 days).
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| Day 25+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 32+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 39+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 46+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 53+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in controls | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 60+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 1+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 3+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 5+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 7+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 9+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 11+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 13+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 15+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 17+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 19+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 21+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 23+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 25+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 27+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 29+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 31+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 33+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 35+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 37+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 39+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 41+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 43+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 45+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 47+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 49+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 51+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 53+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 55+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 57+48 hours |
| Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group | Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs. | Day 59+48 hours |
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. |
| Day 9 |
| Pain or discomfort generated by PICCline dressing changes in controls | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 17 |
| Pain or discomfort generated by PICCline dressing changes in controls | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. | Day 25 |
| Pain or discomfort generated by PICCline dressing changes in controls | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 32 |
| Pain or discomfort generated by PICCline dressing changes in controls | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 39 |
| Pain or discomfort generated by PICCline dressing changes in controls | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 46 |
| Pain or discomfort generated by PICCline dressing changes in controls | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 53 |
| Pain or discomfort generated by PICCline dressing changes in controls | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 60 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 1 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 3 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 5 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 7 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 9 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 11 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 13 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 15 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 17 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 19 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 21 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 23 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 25 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 27 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 29 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 31 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 33 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 35 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 37 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 39 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 41 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 43 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 45 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 47 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 49 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 51 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 53 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 55 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 57 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 59 |
| Pain or discomfort generated by PICCline dressing changes in the experimental group | The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm. | Day 61 |
| Length of time in hospital in controls | The duration of time in hospital will be measured from the first day of receiving chemotherapy until transfer towards a healthcare facility for follow-up and rehabilitation or return home. | At the end of hospitalization |
| Length of time in hospital in the experimental group | The duration of time in hospital will be measured from the first day of receiving chemotherapy until transfer towards a healthcare facility for follow-up and rehabilitation or return home. | At the end of hospitalization |
| Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in controls | If an infection on the PICCline is suspected, the device will be removed and blood cultures will be taken from the PICCLine and the periphery. If the PICCline culture is positive and the blood cultures negative, the infection is local and device-related. If the PICCline culture and peripheral blood cultures are positive, then catheter-related bacteremia is diagnosed. If general signs like fever appear in a patient with a PICCline without local signs of infection, then blood taken from the periphery and blood from the PICCLine will be cultured. If both blood cultures are positive, catheter-related bacteremia is highly probable. If the blood culture bottle taken from the periphery remains negative and there is a strong suspicion of infection related to the PICCline, then new blood cultures from the periphery and from the device will be performed in order to be able to conclude that there is bacteremia/device colonization/contamination. | At the end of the 2-month follow-up, on Day 60 |
| Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in the experimental group | If an infection on the PICCline is suspected, the device will be removed and blood cultures will be taken from the PICCLine and the periphery. If the PICCline culture is positive and the blood cultures negative, the infection is local and device-related. If the PICCline culture and peripheral blood cultures are positive, then catheter-related bacteremia is diagnosed. If general signs like fever appear in a patient with a PICCline without local signs of infection, then blood taken from the periphery and blood from the PICCLine will be cultured. If both blood cultures are positive, catheter-related bacteremia is highly probable. If the blood culture bottle taken from the periphery remains negative and there is a strong suspicion of infection related to the PICCline, then new blood cultures from the periphery and from the device will be performed in order to be able to conclude that there is bacteremia/device colonization/contamination. | At the end of the 2-month follow-up, on Day 60 |
| At the inclusion visit (- 48 hours to Day 0) |
| Body Mass Index of patients in the control group | Body Mass Index = Weight ÷ (Height)2 | At the inclusion visit (- 48 hours to Day 0) |
| Body Mass Index of patients in the experimental group | Body Mass Index = Weight ÷ (Height)2 | At the inclusion visit (- 48 hours to Day 0) |
| Patients' medical history : control group | The medical history of each patient in the control group will be recorded. | At the inclusion visit (- 48 hours to Day 0) |
| Patients' medical history : experimental group | The medical history of each patient in the experimental group will be recorded. | At the inclusion visit (- 48 hours to Day 0) |
| Type of leukemia : control group | The type of leukemia of each patient in the control group will be recorded | At the inclusion visit (- 48 hours to Day 0) |
| Type of leukemia : experimental group | The type of leukemia of each patient in the experimental group will be recorded | At the inclusion visit (- 48 hours to Day 0) |
| Treatment start date : control group | The treatment start date of each patient in the control group will be recorded | At the inclusion visit (- 48 hours to Day 0) |
| Treatment start date : experimental group | The treatment start date of each patient in the experimental group will be recorded | At the inclusion visit (- 48 hours to Day 0) |
| Date when patients' aplasia started : control group | The date when each patient in the control group started aplasia will be recorded | At the inclusion visit (- 48 hours to Day 0) |
| Date when patients' aplasia started : experimental group | The date when each patient in the experimental group started aplasia will be recorded | At the inclusion visit (- 48 hours to Day 0) |
| Date when patients' aplasia ended : control group | The date when each patient in the control group ended their aplasia will be recorded | End of 2-month follow-up |
| Date when patients' aplasia ended : experimental group | The date when each patient in the experimental group ended their aplasia will be recorded | At the end of the 2-month follow-up, on Day 60 |
| Date of hospital discharge : control group | The date when each patient in the control group was discharged from hospital will be recorded. | At the end of the 2-month follow-up, on Day 60 |
| Date of hospital discharge : experimental group | The date when each patient in the experimental group was discharged from hospital will be recorded. | At the end of the 2-month follow-up, on Day 60 |
| Antibiotic therapy provided : control group | The antibiotic therapy provided to each patient in the control group will be recorded | At the end of the 2-month follow-up, on Day 60 |
| Antibiotic therapy provided : experimental group | The antibiotic therapy provided to each patient in the experimental group will be recorded | At the end of the 2-month follow-up, on Day 60 |
| Presence of parenteral nutrition : control group | For each patient in the control group. Recorded as YES/NO | At the end of the 2-month follow-up, on Day 60 |
| Presence of parenteral nutrition : experimental group | For each patient in the experimental group. Recorded as YES/NO | At the end of the 2-month follow-up, on Day 60 |
| Occurrence of thrombosis on the PICCline : control group | For each patient in the control group : YES/NO and date | At the end of the 2-month follow-up, on Day 60 |
| Occurrence of thrombosis on the PICCline : experimental group | For each patient in the experimental group : YES/NO and date | At the end of the 2-month follow-up, on Day 60 |
| Device related data : control group | Device-related data: number and types of previous central lines, history of infection, type of device, number of lines, type of fixation, type of dressing, device use protocols, description of puncture site appearance, related intercurrent events, identified germs will be recorded for each patient in the control group. | At the end of the 2-month follow-up, on Day 60 |
| Device related data : experimental group | Device-related data: number and types of previous central lines, history of infection, type of device, number of lines, type of fixation, type of dressing, device use protocols, description of puncture site appearance, related intercurrent events, identified germs will be recorded for each patient in the experimental group. | At the end of the 2-month follow-up, on Day 60 |