Study Comparing the Efficacy of Peripherally Inserted Central Catheter (PICC) Placement With the Addition of Cyanoacrylate Glue Versus PICC Placement Alone in Patients With Cancer. (PICCandGLUE)

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.

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Procedure: Cyanoacrylate glue application

Detailed Description

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:

• If there is no bleeding, there is no need to apply a compress, and the dressing can be changed on D8 after application;
• In the presence of bleeding, a compress is applied and dressing change is mandatory on D1 after application.

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Centre Leon Berard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, 18 years of age or older on the date of signature the informed consent form
• Patient with a histological diagnosis of cancer
• Indication for central line chemotherapy or immunotherapy
• Placement of a single-lumen PICC in the non-tunneled upper limb planned on an ambulatory basis at the Centre
• Planned duration of PICC use > 30 days
• Dated and signed informed consent, indicating that the patient has been informed of all relevant aspects of the study prior to inclusion;
• Patient covered by a health insurance plan

Exclusion Criteria:

• Patient already included in the study ;
• Patient with known allergy to cyanoacrylates, Violet D&C or formaldehyde;
• Patient not reachable by telephone ;
• Patient under guardianship;
• Patient does not speak French.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICC placement according to standard practice + cyanoacrylate glue; 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.	Procedure: Cyanoacrylate glue application; 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.
No Intervention: PICC placement according to standard practice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	Identification of costs in the community on the basis of patient diaries.	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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Grégoire WALLON, MD, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Actual): June 19, 2024
• Study Completion (Actual): July 19, 2024

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Peripherally Inserted Central Catheter (PICC); Cyanoacrylate Glue
• Other Study ID Numbers: ET23-122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No