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

• Conditions: Central Venous Catheter

• Registration Number: NCT03801811
• Lead Sponsor: University of Parma

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

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-05
• Study First Submitted: 2018-12-28
• Study First Submitted QC: 2019-01-09
• Last Update Submitted: 2019-01-09
• Study First Posted: 2019-01-14
• Last Update Posted: 2019-01-14
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• informed consent signature
• age > 18 years

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visible presence of blood around the emergency site	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Deischence of the surgical wound	15 days	Rate of dehiscence of the surgical wound. This will be assessed by looking for signs of bleeding, pain, fever and inflammation
Systemic infection	15 days	Rate of systemic infections will be evaluated by evaluating the presence of fever
Early infection of the emergency site;	7 days	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

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria di Parma; 🇮🇹 Parma, Italy