Clinical trial NCT05793801: Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia
Official title: Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia
Keywords: Leukemia
Catheters
Dressings
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: University Hospital, Montpellier
First posted: 2023-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective two-center randomized open-label controlled pilot study in two parallel groups according to PICCline dressing repair: (i) Control group (every 8 days, see SF2H recommendations), (ii) Experimental group (every 2 days).
Primary purpose: PREVENTION

Brief summary: Peripherally Inserted Central Catheters have been widely used for many years for the administration of chemotherapy to patients with cancer. However, its use entails significant infectious complications and high risks of death.The hypothesis is that increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.

Detailed description: The PICCline ("Peripherally Inserted Central Catheter") is a central catheter whose brachial insertion is peripheral. It has been widely used for many years for the administration of chemotherapy to patients with cancer. Although its use is growing (2.7 million applications in the USA in 2020), significant infectious complications (especially bacteremia) and even high risks of death are generally associated with it.

In December 2013, the French Society of Hospital Hygiene (SF2H) published a guide of "Recommendations for good practices and management of risks associated with PICC" to help professionals in the use of this device. It states that the rate of dressing repair is set at a maximum of 8 days for a sterile semipermeable transparent dressing; however, this recommendation is based on a questionable level of evidence (grade E level of evidence according to the HAS). In the appendix to this guide, the analysis of the scientific literature does not highlight any articles comparing different dressing repair rates. An observational study was conducted at the University Hospital of Nîmes, in order to determine the rate of infection on PICCline in the Hematology Department. In 2019, out of the 90 PICClines applied (dressing changes every 2 days), 12 infections (local and/or systemic) were noted, i.e. 13.3%.

In order to know the current practices of the different hematology services in France, a survey was conducted to collect protocols for PICCline dressing changes. A total of 23 haematology departments were contacted, 18 of which responded. The observation was made that, although most departments respected the SF2H recommendation (15 out of 18), others proposed different rhythms of care: (a) in the Hematology department at Nîmes University Hospital, dressings are redone every 48 hours, (b) in Montpellier, the frequency was 2 to 3 times a week, (c) in Grenoble, the use of PICCline was abandoned by the medical team who noted too many infections and thromboses associated with this device, and (d) in Toulouse and Strasbourg, the PICCline was used less and less for these same reasons. Moreover, the SF2H recommendations are addressed in a general way to professionals and valid for all patients; but no study can currently affirm that they are applicable to a fragile population of immunocompromised patients in the context of intensive chemotherapy. Hematology patients have a high risk of febrile neutropenia, of around 80%, and this risk of immunosuppression is a non-negligible point in terms of infection prevention during patient management.

In 2019 in France, the Réseau de Prévention des Infections Associées aux Soins launched a campaign to monitor and prevent infections associated with invasive devices. For 3 months, data on the occurrence of infectious episodes were collected in 1001 healthcare facilities. Of the nearly 12,000 bacteremia episodes identified, 25.4% were associated with an intravascular device, 17% of which were PICCline. Moreover, the survey revealed that the highest rates of occurrence were found in the Intensive Care Unit, Oncology and Hematology departments and the prevalence of bacteremia associated with intravascular devices in Hematology represented 39.8%.

Hypothesis : increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 1+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 9+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 17+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 25+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 32+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 39+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 46+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 53+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in controls
timeFrame: Day 60+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 1+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 3+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 5+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 7+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 9+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 11+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 13+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 15+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 17+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 19+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 21+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 23+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 25+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 27+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 29+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 31+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 33+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 35+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 37+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 39+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 41+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 43+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 45+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 47+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 49+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 51+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 53+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 55+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 57+48 hours
measure: Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
timeFrame: Day 59+48 hours
Secondary outcomes:
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 1
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 9
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 17
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 25
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 32
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 39
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 46
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 53
measure: Pain or discomfort generated by PICCline dressing changes in controls
timeFrame: Day 60
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 1
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 3
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 5
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 7
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 9
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 11
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 13
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 15
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 17
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 19
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 21
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 23
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 25
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 27
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 29
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 31
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 33
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 35
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 37
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 39
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 41
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 43
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 45
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 47
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 49
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 51
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 53
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 55
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 57
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 59
measure: Pain or discomfort generated by PICCline dressing changes in the experimental group
timeFrame: Day 61
measure: Length of time in hospital in controls
timeFrame: At the end of hospitalization
measure: Length of time in hospital in the experimental group
timeFrame: At the end of hospitalization
measure: Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in controls
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in the experimental group
timeFrame: At the end of the 2-month follow-up, on Day 60
Other outcomes:
measure: Age of patients in the control group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Age of patients in the experimental group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Body Mass Index of patients in the control group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Body Mass Index of patients in the experimental group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Patients' medical history : control group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Patients' medical history : experimental group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Type of leukemia : control group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Type of leukemia : experimental group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Treatment start date : control group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Treatment start date : experimental group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Date when patients' aplasia started : control group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Date when patients' aplasia started : experimental group
timeFrame: At the inclusion visit (- 48 hours to Day 0)
measure: Date when patients' aplasia ended : control group
timeFrame: End of 2-month follow-up
measure: Date when patients' aplasia ended : experimental group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Date of hospital discharge : control group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Date of hospital discharge : experimental group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Antibiotic therapy provided : control group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Antibiotic therapy provided : experimental group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Presence of parenteral nutrition : control group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Presence of parenteral nutrition : experimental group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Occurrence of thrombosis on the PICCline : control group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Occurrence of thrombosis on the PICCline : experimental group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Device related data : control group
timeFrame: At the end of the 2-month follow-up, on Day 60
measure: Device related data : experimental group
timeFrame: At the end of the 2-month follow-up, on Day 60
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier Hôpital St-Eloi
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Julie LASSALLE, Mme.
role: PRINCIPAL_INVESTIGATOR
References: