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

NCT ID: NCT05793801

Last Updated: 2025-04-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2027-09-01

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.

Conditions

Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Dressing change

Intervention Type: 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.

Experimental group

Patients whose dressings are changed every other day.

Group Type: EXPERIMENTAL

Dressing change

Intervention Type: 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.

Interventions

Dressing change

The patient circuit corresponds to that of usual care.

Not part of usual patient management:

• The rhythm of PICCline dressing changes, which differed between the two groups.
• The collection of pain on a visual analog scale at each dressing change.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie LASSALLE, Mme.

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

CHU de Montpellier Hôpital St-Eloi

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Éric JOURDAN, Dr.

Role: CONTACT

Eric.jourdan@chu-nimes.fr

+334.66.68.32.34

Anissa MEGZARI

Role: CONTACT

drc@chu-nimes.fr

+33466684236

Facility Contacts

Séverine LOURS, Mme.

Role: primary

s-lours@chu-montpellier.fr

+334 67 33 83 77

Franciane PAUL, Dr.

Role: backup

f-paul@chu-montpellier.fr

+334.67.33.83.55

Other Identifiers

NIMAO/2021-2/JL-01

Identifier Type: -

Identifier Source: org_study_id