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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05793801
Other study ID # NIMAO/2021-2/JL-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 6, 2023
Est. completion date September 1, 2025

Study information

Verified date June 2023
Source Centre Hospitalier Universitaire de Nimes
Contact Éric JOURDAN, Dr.
Phone +334.66.68.32.34
Email Eric.jourdan@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 1, 2025
Est. primary completion date June 6, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with a diagnosis of acute myeloblastic leukemia. - Patient going on intensive induction chemotherapy (causing a "high risk" situation of severe infection defined as profound neutropenia ( Polymorphonuclear neutrophil count <500/mm3) and lasting (>7 days). - Patients who have had a PICCline placed within the last 24 hours or who require a PICCline placement as part of their hospitalization under optimal hygiene and asepsis conditions. - Patient housed in a protected environment (flow chamber or Plasmair®). - Patient who has given free and informed consent. - Patient affiliated or beneficiary of a health insurance plan. - Adult patient (=18 years old). Exclusion Criteria: - Patient with PICCline placed during a previous hospitalization. - Patient in an exclusion period determined by another study. - Patient under court protection, guardianship or curatorship. - Patient unable to give consent. - Patient for whom it is impossible to give informed information.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dressing change
The patient circuit corresponds to that of usual care. Not part of usual patient management: The rhythm of PICCline dressing changes, which differed between the two groups. The collection of pain on a visual analog scale at each dressing change.

Locations

Country Name City State
France CHU de Montpellier Hôpital St-Eloi Montpellier

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Age of patients in the control group In years At the inclusion visit (- 48 hours to Day 0)
Other Age of patients in the experimental group In years At the inclusion visit (- 48 hours to Day 0)
Other Body Mass Index of patients in the control group Body Mass Index = Weight ÷ (Height)2 At the inclusion visit (- 48 hours to Day 0)
Other Body Mass Index of patients in the experimental group Body Mass Index = Weight ÷ (Height)2 At the inclusion visit (- 48 hours to Day 0)
Other 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)
Other 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)
Other 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)
Other 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)
Other 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)
Other 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)
Other 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)
Other 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)
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Primary 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
Primary 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
Primary 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
Primary 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 25+48 hours
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Secondary 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
Secondary 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 9
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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