Use of the Skin Glue in the Placement of Central Venous Catheters Port a Catch (Port glue cvc)

Prospective Observational Study on the Safety and Efficacy of Cyanoacrylate Skin Glues to Reduce the Risk of Complications After Insertion of Totally Implantable Central Venous Catheters Port-a-Cath

The use of glue as a device in the implantation of central venous catheters has recently been introduced into European clinical practice, initially with the aim of blocking bleeding at the point of exit of the PICCs, but at the same time also to close the cutaneous incision practiced to create the PORT positioning pocket.

It is possible that the surgical incision created for the insertion of the PORT may undergo complications such as: local bleeding, infections or wounds of the surgical wound.

A solution to this problem could be the application of the cyanoacrylate dermal glue on the edges of the surgical wound, after intradermal suture. The glue would have the purpose of sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect and create a potential barrier against infections.

Study Overview

• Status: Unknown
• Conditions: Central Venous Catheter
• Intervention / Treatment: Procedure: Study of the efficacy of using skin glue in the application of Port a cath

Detailed Description

Patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by a numeric code, until hospital discharge.

The parameters analized will be related to:

• essential patient data (identification number, gender, age, height weight)
• basic diseases
• associated diseases and risk factors
• origin of the patient (department or home)
• reason for positioning
• hemorrhagic complications detected in the first 24 hours
• hemorrhagic complications detected in the first 7 days
• non-bleeding complications detected at 7 days (local and systemic infections, wound delescence)

The data wil be transferred to an Excel worksheet, in order to conduct a descriptive analysis related to every variable

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Elena Giovanna Bignami, MD; Phone Number: +39 0525033609; Email: elenagiovanna.bignami@unipr.it

Study Locations

• Italy
  • Parma, Italy, 43126
    • Recruiting
    • Azienda Ospedaliera Universitaria di Parma
    • Contact: Elena Giovanna Bignami, MD
    • Sub-Investigator: Giada Maspero, MD
    • Sub-Investigator: Giuseppina Palumbo, MD
    • Sub-Investigator: Selene Ranocchia, MD
    • Sub-Investigator: Andrea Rossi, Nurse
    • Sub-Investigator: Nicolò Gallina, MD Student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

critical ill patients

Description

Inclusion Criteria:

• informed consent signature
• age > 18 years

Exclusion Criteria:

• Age> 90 years
• Cianoacrilate allergy
• Presence of bacteraemia
• Informed consent refusal

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visible presence of blood around the emergency site	Evaluate the effectiveness of cyanoacrylate glue in reducing / eliminating bleeding local from the insertion site after PORT implantation (evaluated as visible presence of blood around the emergency site.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early infection of the emergency site;	Rate of early infection of the emergency site; Early infection of the emergency site is assessed by observing skin changes as the presence of: pain, hot skin and reddened skin	7 days
Deischence of the surgical wound	Rate of dehiscence of the surgical wound. This will be assessed by looking for signs of bleeding, pain, fever and inflammation	15 days
Systemic infection	Rate of systemic infections will be evaluated by evaluating the presence of fever	15 days

Collaborators and Investigators

• Sponsor: University of Parma

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: CVC; Port; Glue
• Other Study ID Numbers: 382/2018/DISP/AOUPR

Drug and device information, study documents

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