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.

NCT ID: NCT05944900

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2024-07-19

Brief Summary

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cyanoacrylate glue application

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grégoire WALLON, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Léon Bérard

Lyon, , France

Countries

France

Other Identifiers

ET23-122

Identifier Type: -

Identifier Source: org_study_id