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.

Cancer Clinical Trial

— PICCandGLUE  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944900
• Other study ID #: ET23-122
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: September 2023
• Source: Centre Leon Berard
• Contact: Grégoire WALLON, MD
• Phone: 04 78 78 27 53
• Email: gregoire.wallon[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Incidence of PICC removal before day 30	Incidence of PICC removal for any reason within 30 days following placement.	Up to day 30
Secondary	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