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Patients receiving normal management with dressings changed once a week according to the SF2H recommendations.

Patients whose dressings are changed every other day.

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.

Dressing change

Éric JOURDAN, Dr.

Anissa MEGZARI

Séverine LOURS, Mme.

Franciane PAUL, Dr.

Julie LASSALLE, Mme.

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

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

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

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

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

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

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).

Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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.

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.

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia	NCT05793801	Leukemia	Dressing change	18 Years -	Centre Hospitalier Universitaire de Nīmes
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia	NCT05793801	Leukemia	Dressing change	18 Years -	Centre Hospitalier Universitaire de Nīmes
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia	NCT05793801	Leukemia	Dressing change	18 Years -	Centre Hospitalier Universitaire de Nīmes

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