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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05793801
Acronym
LEUKA-PICC
Enrollment
60
Registered
2023-03-31
Start date
2023-06-06
Completion date
2027-09-01
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

Leukemia, Catheters, Dressings

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.

Interventions

OTHERDressing 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.

Sponsors

University Hospital, Montpellier
CollaboratorOTHER
Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental groupDay 1+48 hoursOccurrence 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.
Rate of local and/or systemic occurrence of infection on the PICCline in controlsDay 1+48 hoursOccurrence 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

MeasureTime frameDescription
Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in the experimental groupAt the end of the 2-month follow-up, on Day 60If 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.
Pain or discomfort generated by PICCline dressing changes in the experimental groupDay 1The 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.
Length of time in hospital in controlsAt the end of hospitalizationThe 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.
Length of time in hospital in the experimental groupAt the end of hospitalizationThe 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.
Pain or discomfort generated by PICCline dressing changes in controlsDay 1The 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.
Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in controlsAt the end of the 2-month follow-up, on Day 60If 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

MeasureTime frameDescription
Type of leukemia : control groupAt the inclusion visit (- 48 hours to Day 0)The type of leukemia of each patient in the control group will be recorded
Type of leukemia : experimental groupAt the inclusion visit (- 48 hours to Day 0)The type of leukemia of each patient in the experimental group will be recorded
Treatment start date : control groupAt the inclusion visit (- 48 hours to Day 0)The treatment start date of each patient in the control group will be recorded
Treatment start date : experimental groupAt the inclusion visit (- 48 hours to Day 0)The treatment start date of each patient in the experimental group will be recorded
Date when patients' aplasia started : experimental groupAt the inclusion visit (- 48 hours to Day 0)The date when each patient in the experimental group started aplasia will be recorded
Date when patients' aplasia ended : control groupEnd of 2-month follow-upThe date when each patient in the control group ended their aplasia will be recorded
Date when patients' aplasia ended : experimental groupAt the end of the 2-month follow-up, on Day 60The date when each patient in the experimental group ended their aplasia will be recorded
Date of hospital discharge : control groupAt the end of the 2-month follow-up, on Day 60The date when each patient in the control group was discharged from hospital will be recorded.
Date of hospital discharge : experimental groupAt the end of the 2-month follow-up, on Day 60The date when each patient in the experimental group was discharged from hospital will be recorded.
Antibiotic therapy provided : control groupAt the end of the 2-month follow-up, on Day 60The antibiotic therapy provided to each patient in the control group will be recorded
Antibiotic therapy provided : experimental groupAt the end of the 2-month follow-up, on Day 60The antibiotic therapy provided to each patient in the experimental group will be recorded
Presence of parenteral nutrition : control groupAt the end of the 2-month follow-up, on Day 60For each patient in the control group. Recorded as YES/NO
Presence of parenteral nutrition : experimental groupAt the end of the 2-month follow-up, on Day 60For each patient in the experimental group. Recorded as YES/NO
Occurrence of thrombosis on the PICCline : control groupAt the end of the 2-month follow-up, on Day 60For each patient in the control group : YES/NO and date
Occurrence of thrombosis on the PICCline : experimental groupAt the end of the 2-month follow-up, on Day 60For each patient in the experimental group : YES/NO and date
Device related data : control groupAt the end of the 2-month follow-up, on Day 60Device-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 : experimental groupAt the end of the 2-month follow-up, on Day 60Device-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.
Age of patients in the control groupAt the inclusion visit (- 48 hours to Day 0)In years
Age of patients in the experimental groupAt the inclusion visit (- 48 hours to Day 0)In years
Body Mass Index of patients in the control groupAt the inclusion visit (- 48 hours to Day 0)Body Mass Index = Weight ÷ (Height)2
Body Mass Index of patients in the experimental groupAt the inclusion visit (- 48 hours to Day 0)Body Mass Index = Weight ÷ (Height)2
Patients' medical history : control groupAt the inclusion visit (- 48 hours to Day 0)The medical history of each patient in the control group will be recorded.
Date when patients' aplasia started : control groupAt the inclusion visit (- 48 hours to Day 0)The date when each patient in the control group started aplasia will be recorded
Patients' medical history : experimental groupAt the inclusion visit (- 48 hours to Day 0)The medical history of each patient in the experimental group will be recorded.

Countries

France

Contacts

Primary ContactÉric JOURDAN, Dr.
Eric.jourdan@chu-nimes.fr+334.66.68.32.34
Backup ContactAnissa MEGZARI
drc@chu-nimes.fr+33466684236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026