Centre Léon Bérard
Lyon, France
NCT Number: NCT05944900
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.
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Notify MePeripherally 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Hour 0
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.
Time frame: Up to hour 1
Proportion of patients requiring dressing changes at the CLB within one hour of the end of procedure
Time frame: Up to day 8
Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 8)
Time frame: Up to day 30
Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 30)
Time frame: Up to day 30
Incidence of PICC removal for any reason within 30 days following placement.
Time frame: Up to day 30
Incidence of PICC-related complications (infection, thrombotic event, obstruction, displacement requiring PICC replacement or not) in the 30 days following placement.
Time frame: Up to day 30
Costs related to consumption of care in healthcare institutions (hospitalisations for insertion and removal of PICC catheters, for complications related to PICC, etc.).
Time frame: Up to day 30
Identification of costs in the community on the basis of patient diaries.
Time frame: Up to day 30
Sensitivity analysis on main cost parameters represented graphically by tornado diagrams to analyze the impact of variations in key cost parameters.
Time frame: Up to day 30
Sensitivity analysis represented by a 95% confidence interval to assess the robustness of the cost-effectiveness results.
Time frame: Up to day 30
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.
Time frame: Up to day 30
Proportion of patients for whom PICC insertion was successful without major complications, as performance indicator
Time frame: Up to day 30
Total time spent on medical interventions throughout the patient's care pathway, including initial application, re-dressing and management of complications, as performance indicator
Time frame: Up to day 30
Total costs of patient care, including hospital and community costs, as performance indicator
Centre Leon Berard
Other
Randomized, Prospective, Single-center Trial Comparing the Efficacy of Peripherally Inserted Central Catheter (PICC) Placement With the Addition of Cyanoacrylate Glue Versus PICC Placement Alone (Without Glue) in Patients With Cancer.
Acronym: PICCandGLUE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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