Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Feasibility for a definitive RCT
研究概览
简要总结
The goal of this clinical trial is to compare a chlorhexidine impregnated dressing for peripheral intravenous catheters (PIVCs) to the standard dressing currently used in general medical and surgical inpatient wards.
The main questions it aims to answer are:
- Study Feasibility
- Occurrence of infectious complications related to the PIVC
Participants will be randomly allocated to receive either of the below dressings to cover and secure their PIVC:
- The standard dressing used at their hospital, or
- The intervention dressing which has Chlorhexidine gluconate (CHG) on it
Researchers will compare standard and CHG dressings to see if the presence of CHG improves the occurrence of infectious complications related to the PIVC.
详细描述
This study is a multi-centre, two-arm, parallel group adaptive Randomized Controlled Trial (RCT) to test effectiveness, cost-effectiveness, and safety of 3M™ Tegaderm™ Antimicrobial IV Advanced Securement dressings with standard polyurethane dressings for PIVCs. The study has two phases. Phase I is an internal feasibility pilot for which only feasibility outcomes will be considered (no analysis). At this time (n=300) an independent Data Safety Monitoring Committee (DSMC) comprised of a biostatistician, physician and expert trialist will review pre-defined blinded analyses of feasibility and safety data. Phase II will then go ahead if feasibility outcomes are satisfactory, and will involve continuation of trial recruitment to complete a definitive RCT. If Phase II does not proceed then all outcomes will be reported at the end of Phase I.
Setting and sample:
Australia: The ProP Trial will be undertaken in the general medical/surgical and oncology/hematology departments at the Queensland Children's Hospital (QCH; Site 1), and the general medical/surgical departments at the Royal Brisbane and Women's Hospital (RBWH; Site 2) Brisbane, Australia. These are both large quaternary referral teaching hospitals (Site 1: 359 beds; Site 2: 929 beds).
France: The ProP Trial will be undertaken in the University Hospital of Poitiers (PUH), a large referral teaching hospital with 959 acute beds. Patients will be recruited at the Emergency Department, before being admitted to medical wards.
Sample size:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, blinding of patients/clinicians to the intervention is not possible. However, the statistician will be blinded for analysis; and the microbiologist and laboratory staff will also be blinded to treatment allocation when apportioning infection outcomes.
Additionally, at the completion of Phase 1 (n=300) an independent data safety monitoring committee (DSMC) comprised of a biostatistician, physician and expert trialist, will review pre-defined blinded analyses, conducting a review of feasibility and safety data to determine if the trial should continue to a fully powered RCT.
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PIVC to be inserted with expected dwell >48 hours
- •Provided written and informed consent (patient or carer)
- •Australia only
- •≥6 years of age (due to size of dressing)
- •France only
- •≥18 years of age
排除标准
- •Burned, non-intact or scarred skin at the insertion site
- •Known allergy to CHG or transparent dressing adhesives
- •Palliative care patients on end-of-life pathway
- •Patient who has already participated in the study
- •Placement of a PIVC in an emergency, that does not allow the usual rules of hygiene for insertion to be adhered to.
- •Additional exclusions to Australian study only
- •Non-English-speaking patients without interpreter
- •Under the care of Child and Family Services and unable to gain consent from case worker (paediatric patients)
- •Additional exclusions to French study only
- •Patients not benefiting from the French Social Security scheme or not benefiting from it through a third party,
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
- •Known pregnant or breastfeeding women
- •Predictably difficult vascular access (IV drug addiction, obesity)
研究组 & 干预措施
Control
Bordered Polyurethane Dressing
干预措施: Standard bordered polyurethane dressing (Device)
Intervention
CHG Bordered Polyurethane Dressing
干预措施: Chlorhexidine gluconate impregnated bordered polyurethane dressing (Device)
结局指标
主要结局
Feasibility for a definitive RCT
时间窗: On completion of 300 participants
The feasibility of conducting a definitive RCT will be assessed against the following criteria: i. Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion) ii. Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study) iii. Retention of study participants (\<10% will be lost to follow up) iv. Protocol fidelity of study participants (≥80% will receive the allocated intervention) v. Missing data for primary outcome 2 (\<5% of primary outcome 2 data will be unable to be collected) vi. Satisfaction of participants/parents and staff (\<10% report "low" satisfaction with the intervention arm (rated low/medium/high) vii. An estimate of catheter-related infectious complications (defined as per primary outcome 2) in the control group that indicate a fully powered multi-site RCT is achievable
Catheter-related infectious complications and phlebitis
时间窗: Daily until 48hours after study PIVC is removed.
Proportion of patients with a composite measure of PIVC Colonization; PIVC local infection; PIVC-associated Bloodstream Infection (BSI) and Phlebitis. These measures are defined below in secondary outcomes. If patients meet more than one of the following \[e.g., phlebitis and PIVC local infection\], both will be collected however only counted once for the composite measure.
次要结局
- Serious adverse event(Daily until 48hours after study PIVC is removed.)
- PIVC-associated Bloodstream Infection(Daily until 48hours after study PIVC is removed.)
- Skin colonization(On study PIVC removal)
- Patient reported experience measures of the dressing(Daily until 48hours after study PIVC is removed.)
- PIVC tip colonization(Daily until 48hours after study PIVC is removed.)
- PIVC device failure(Daily until 48hours after study PIVC is removed.)
- PIVC local infection without Bloodstream Infection (BSI)(Daily until 48hours after study PIVC is removed.)
- Phlebitis(Daily until 48hours after study PIVC is removed.)
- Adverse skin event(Daily until 48hours after study PIVC is removed.)
- Cost effectiveness(Until discharge.)
- Dressing durability(Daily until study PIVC is removed.)
- Clinician reported experience measures of the dressing including application and removal(Daily until 48hours after study PIVC is removed.)