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This is a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in cancer patients.
Peripherally Inserted Central Catheters (PICCs) are a form of vascular access inserted percutaneously into a vein, usually in the arm, with the distal end at the atrio cava junction (between the superior vena cava and the right atrium). They may be used for a prolonged period or for several days, repeatedly over time (as is the case for certain chemotherapies, parenteral nutrition or long-term intravenous treatments).
Their placement requires aseptic surgical conditions, and a team trained in the procedure, sometimes grouped together in a Vascular Access Unit (UAV).
A PICC is inserted by puncturing the skin and subcutaneous tissues, and securing the catheter with a "Statlock" type stabilizer. The catheter exit point must be covered, at a minimum by a sterile occlusive dressing with a transparent semi-permeable membrane, otherwise referred to as a "transparent dressing".
According to available data, tissue puncture results in bleeding at the puncture site in 25% to 40% of procedures. This bleeding necessitates the application of a sterile compress prior to covering with a transparent dressing. The skin puncture site (also known as the catheter exit point) requires the dressing to be repeated on D1 after insertion.
To sum up:
PICC placement combined with the use of cyanoacrylate glue would reduce the risk of bleeding, and therefore the need to use of a compress, compared with a standard procedure (without the use of glue).
On this basis, the investigators propose to conduct a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in patients with cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICC placement according to standard practice + cyanoacrylate glue | Experimental | PICC placement will be performed according to standard practice (Safe Insertion of PICC protocol (SIP2) steps). The catheter will be secured by the Statlock system. Cyanoacrylate glue will be applied on the catheter exit point in accordance with the instructions for use. A transparent dressing will be applied, with a compress in the event of bleeding. |
|
| PICC placement according to standard practice | No Intervention | PICC placement will be performed according to standard practice (Safe Insertion of PICC protocol (SIP2) steps). The catheter will be secured by the Statlock system. A transparent dressing will be applied, with a compress in the event of bleeding. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanoacrylate glue application | Procedure | The wound must be positioned in a horizontal plane, and the glueapplied uniformly overhanging the wound. Cyanoacrylate glue is contraindicated when adhesion cannot be achieved. Cyanoacrylate glue should be applied in accordance with the instructions for use. Wound-closing properties are only fully achieved once the first layer has fully polymerized. This depends on skin type, skin hydration and ambient humidity. If a second layer is applied, the polymerization time is extended accordingly. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with successful PICC placement | Success is defined by the possibility of using a dressing without compression at application (at hour 0), i.e. without bleeding after the defined compression time. | Hour 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of dressing changes within one hour | Proportion of patients requiring dressing changes at the CLB within one hour of the end of procedure | Up to hour 1 |
| Proportion of dressing changes before day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost analysis in healthcare institutions | Costs related to consumption of care in healthcare institutions (hospitalisations for insertion and removal of PICC catheters, for complications related to PICC, etc.). | Up to day 30 |
| Cost analysis in the community |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grégoire WALLON, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | France |
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The randomization (1:1 ratio) will be stratified according to the risk of haemostasis disorders (Presence of at least one risk factor (medication interfering with hemostasis, innate or acquired coagulation disorder, thrombocytopenia) vs. no risk).
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Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 8)
| Up to day 8 |
| Proportion of dressing changes before day 30 | Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 30) | Up to day 30 |
| Incidence of PICC removal before day 30 | Incidence of PICC removal for any reason within 30 days following placement. | Up to day 30 |
| Incidence of PICC-related complications before day 30 | Incidence of PICC-related complications (infection, thrombotic event, obstruction, displacement requiring PICC replacement or not) in the 30 days following placement. | Up to day 30 |
Identification of costs in the community on the basis of patient diaries.
| Up to day 30 |
| Deterministic Sensitivity Analysis | Sensitivity analysis on main cost parameters represented graphically by tornado diagrams to analyze the impact of variations in key cost parameters. | Up to day 30 |
| Probabilistic Sensitivity Analysis | Sensitivity analysis represented by a 95% confidence interval to assess the robustness of the cost-effectiveness results. | Up to day 30 |
| Organisational impacts | Assessment of organisational impacts using a modelling tool to break down patient flows and a simulation tool to simulate scenarios in order to assess organisational needs and constraints. | Up to day 30 |
| Success rate of PICC placement strategy | Proportion of patients for whom PICC insertion was successful without major complications, as performance indicator | Up to day 30 |
| Total duration of medical interventions | Total time spent on medical interventions throughout the patient's care pathway, including initial application, re-dressing and management of complications, as performance indicator | Up to day 30 |
| Assessment of cost of care | Total costs of patient care, including hospital and community costs, as performance indicator | Up to day 30 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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