Use of the Skin Glue in the Placement of Central Venous Catheters Port a Catch

NCT ID: NCT03801811

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2019-04-30

Brief Summary

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.

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

Conditions

Central Venous Catheter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Study of the efficacy of using skin glue in the application of 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. It is possible that the surgical incision created for the insertion of the PORT may be subject to complications such as: local bleeding, which if not properly treated may last even a few days, infections or surgical wound outbreaks. This possibility of bleeding occurs more easily in patients suffering from coagulation problems or when appropriate preventive measures have not been taken at the time of implantation of the device. 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 bacterial infections.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• informed consent signature
• age > 18 years

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Parma

OTHER

Sponsor Role: lead

Responsible Party

Elena Giovanna Bignami

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Universitaria di Parma

Parma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elena Giovanna Bignami, MD

Role: CONTACT

elenagiovanna.bignami@unipr.it

+39 0525033609

Facility Contacts

Elena Giovanna Bignami, MD

Role: primary

Other Identifiers

382/2018/DISP/AOUPR

Identifier Type: -

Identifier Source: org_study_id