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NCT Number: NCT05793801

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dressing change

Other

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.

Primary outcomes

  1. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 1+48 hours

    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.

  2. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 9+48 hours

    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.

  3. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 17+48 hours

    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.

  4. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 25+48 hours

    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.

  5. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 32+48 hours

    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.

  6. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 39+48 hours

    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.

  7. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 46+48 hours

    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.

  8. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 53+48 hours

    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.

  9. Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Time frame: Day 60+48 hours

    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.

  10. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 1+48 hours

    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.

  11. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 3+48 hours

    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.

  12. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 5+48 hours

    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.

  13. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 7+48 hours

    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.

  14. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 9+48 hours

    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.

  15. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 11+48 hours

    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.

  16. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 13+48 hours

    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.

  17. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 15+48 hours

    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.

  18. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 17+48 hours

    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.

  19. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 19+48 hours

    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.

  20. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 21+48 hours

    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.

  21. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 23+48 hours

    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.

  22. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 25+48 hours

    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.

  23. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 27+48 hours

    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.

  24. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 29+48 hours

    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.

  25. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 31+48 hours

    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.

  26. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 33+48 hours

    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.

  27. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 35+48 hours

    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.

  28. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 37+48 hours

    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.

  29. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 39+48 hours

    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.

  30. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 41+48 hours

    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.

  31. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 43+48 hours

    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.

  32. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 45+48 hours

    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.

  33. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 47+48 hours

    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.

  34. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 49+48 hours

    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.

  35. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 51+48 hours

    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.

  36. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 53+48 hours

    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.

  37. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 55+48 hours

    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.

  38. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 57+48 hours

    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.

  39. Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Time frame: Day 59+48 hours

    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.

Secondary outcomes

  1. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 1

    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.

  2. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 9

    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.

  3. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 17

    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.

  4. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 25

    The patient will be asked to evaluate pain according to a visual analog scale following each dressing change.

  5. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 32

    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.

  6. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 39

    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.

  7. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 46

    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.

  8. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 53

    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.

  9. Pain or discomfort generated by PICCline dressing changes in controls

    Time frame: Day 60

    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.

  10. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 1

    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.

  11. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 3

    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.

  12. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 5

    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.

  13. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 7

    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.

  14. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 9

    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.

  15. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 11

    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.

  16. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 13

    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.

  17. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 15

    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.

  18. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 17

    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.

  19. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 19

    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.

  20. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 21

    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.

  21. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 23

    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.

  22. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 25

    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.

  23. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 27

    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.

  24. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 29

    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.

  25. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 31

    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.

  26. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 33

    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.

  27. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 35

    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.

  28. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 37

    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.

  29. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 39

    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.

  30. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 41

    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.

  31. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 43

    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.

  32. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 45

    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.

  33. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 47

    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.

  34. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 49

    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.

  35. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 51

    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.

  36. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 53

    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.

  37. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 55

    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.

  38. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 57

    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.

  39. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 59

    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.

  40. Pain or discomfort generated by PICCline dressing changes in the experimental group

    Time frame: Day 61

    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.

  41. Length of time in hospital in controls

    Time frame: At the end of hospitalization

    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.

  42. Length of time in hospital in the experimental group

    Time frame: At the end of hospitalization

    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.

  43. Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in controls

    Time frame: At the end of the 2-month follow-up, on Day 60

    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.

  44. Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in the experimental group

    Time frame: At the end of the 2-month follow-up, on Day 60

    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.

Other outcomes

  1. Age of patients in the control group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    In years

  2. Age of patients in the experimental group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    In years

  3. Body Mass Index of patients in the control group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    Body Mass Index = Weight ÷ (Height)2

  4. Body Mass Index of patients in the experimental group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    Body Mass Index = Weight ÷ (Height)2

  5. Patients' medical history : control group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    The medical history of each patient in the control group will be recorded.

  6. Patients' medical history : experimental group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    The medical history of each patient in the experimental group will be recorded.

  7. Type of leukemia : control group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    The type of leukemia of each patient in the control group will be recorded

  8. Type of leukemia : experimental group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    The type of leukemia of each patient in the experimental group will be recorded

  9. Treatment start date : control group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    The treatment start date of each patient in the control group will be recorded

  10. Treatment start date : experimental group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    The treatment start date of each patient in the experimental group will be recorded

  11. Date when patients' aplasia started : control group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    The date when each patient in the control group started aplasia will be recorded

  12. Date when patients' aplasia started : experimental group

    Time frame: At the inclusion visit (- 48 hours to Day 0)

    The date when each patient in the experimental group started aplasia will be recorded

  13. Date when patients' aplasia ended : control group

    Time frame: End of 2-month follow-up

    The date when each patient in the control group ended their aplasia will be recorded

  14. Date when patients' aplasia ended : experimental group

    Time frame: At the end of the 2-month follow-up, on Day 60

    The date when each patient in the experimental group ended their aplasia will be recorded

  15. Date of hospital discharge : control group

    Time frame: At the end of the 2-month follow-up, on Day 60

    The date when each patient in the control group was discharged from hospital will be recorded.

  16. Date of hospital discharge : experimental group

    Time frame: At the end of the 2-month follow-up, on Day 60

    The date when each patient in the experimental group was discharged from hospital will be recorded.

  17. Antibiotic therapy provided : control group

    Time frame: At the end of the 2-month follow-up, on Day 60

    The antibiotic therapy provided to each patient in the control group will be recorded

  18. Antibiotic therapy provided : experimental group

    Time frame: At the end of the 2-month follow-up, on Day 60

    The antibiotic therapy provided to each patient in the experimental group will be recorded

  19. Presence of parenteral nutrition : control group

    Time frame: At the end of the 2-month follow-up, on Day 60

    For each patient in the control group. Recorded as YES/NO

  20. Presence of parenteral nutrition : experimental group

    Time frame: At the end of the 2-month follow-up, on Day 60

    For each patient in the experimental group. Recorded as YES/NO

  21. Occurrence of thrombosis on the PICCline : control group

    Time frame: At the end of the 2-month follow-up, on Day 60

    For each patient in the control group : YES/NO and date

  22. Occurrence of thrombosis on the PICCline : experimental group

    Time frame: At the end of the 2-month follow-up, on Day 60

    For each patient in the experimental group : YES/NO and date

  23. Device related data : control group

    Time frame: At the end of the 2-month follow-up, on Day 60

    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.

  24. Device related data : experimental group

    Time frame: At the end of the 2-month follow-up, on Day 60

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

+33466684236

Éric JOURDAN, Dr.

CONTACT

[email protected]

+334.66.68.32.34

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • University Hospital, Montpellier

Registry information

Acronym: LEUKA-PICC

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2023
Registry last updated
Apr 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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