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Completed

NCT Number: NCT05944900

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.

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard

Lyon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Rate of patients with successful PICC placement

    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.

Secondary outcomes

  1. Proportion of dressing changes within one hour

    Time frame: Up to hour 1

    Proportion of patients requiring dressing changes at the CLB within one hour of the end of procedure

  2. Proportion of dressing changes before day 8

    Time frame: Up to day 8

    Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 8)

  3. Proportion of dressing changes before day 30

    Time frame: Up to day 30

    Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 30)

  4. Incidence of PICC removal before day 30

    Time frame: Up to day 30

    Incidence of PICC removal for any reason within 30 days following placement.

  5. Incidence of PICC-related complications before day 30

    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.

Other outcomes

  1. Cost analysis in healthcare institutions

    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.).

  2. Cost analysis in the community

    Time frame: Up to day 30

    Identification of costs in the community on the basis of patient diaries.

  3. Deterministic Sensitivity Analysis

    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.

  4. Probabilistic Sensitivity Analysis

    Time frame: Up to day 30

    Sensitivity analysis represented by a 95% confidence interval to assess the robustness of the cost-effectiveness results.

  5. Organisational impacts

    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.

  6. Success rate of PICC placement strategy

    Time frame: Up to day 30

    Proportion of patients for whom PICC insertion was successful without major complications, as performance indicator

  7. Total duration of medical interventions

    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

  8. Assessment of cost of care

    Time frame: Up to day 30

    Total costs of patient care, including hospital and community costs, as performance indicator

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2023
Registry last updated
Sep 27, 2024

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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