Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of local and/or systemic occurrence of infection on the PICCline in controls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Rate of local and/or systemic occurrence of infection on the PICCline in controls
时间窗: 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.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
时间窗: 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.
次要结局
- Pain or discomfort generated by PICCline dressing changes in the experimental group(Day 61)
- Length of time in hospital in controls(At the end of hospitalization)
- Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in the experimental group(At the end of the 2-month follow-up, on Day 60)
- Pain or discomfort generated by PICCline dressing changes in controls(Day 60)
- Length of time in hospital in the experimental group(At the end of hospitalization)
- Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in controls(At the end of the 2-month follow-up, on Day 60)
