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.

NCT05944900 | Completed

• 1 other identifier: ET23-122
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Peripherally Inserted Central Catheter (PICC); Cyanoacrylate Glue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of dressing changes within one hour

  Up to hour 1

• Proportion of dressing changes before day 8

  Up to day 8

• Proportion of dressing changes before day 30

  Up to day 30

• Incidence of PICC removal before day 30

  Up to day 30

• Incidence of PICC-related complications before day 30

  Up to day 30

Other Outcomes (8)

• Cost analysis in healthcare institutions

  Up to day 30

• Cost analysis in the community

  Up to day 30

• Deterministic Sensitivity Analysis

  Up to day 30

Study Arms (2)

PICC placement according to standard practice + cyanoacrylate glue

EXPERIMENTAL

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

PICC placement according to standard practice

NO INTERVENTION

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.

Interventions

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.

PICC placement according to standard practice + cyanoacrylate glue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient covered by a health insurance plan

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Grégoire WALLON, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomization (1:1 ratio) will be stratified according to the risk of haemostasis disorders (Presence of at least one risk factor (medication interfering with hemostasis, innate or acquired coagulation disorder, thrombocytopenia) vs. no risk).

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: August 2, 2023
• Primary Completion: June 19, 2024
• Study Completion: July 19, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

FR (1)