Leukemia Clinical Trial
— LEUKA-PICCOfficial title:
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Montpellier Hôpital St-Eloi | Montpellier |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes | University Hospital, Montpellier |
France,
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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