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

Central Venous Catheter Clinical Trial

— Port glue cvc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03801811
• Other study ID #: 382/2018/DISP/AOUPR
• Status: Recruiting
• Start date: September 5, 2018
• Est. completion date: April 2019

Study information

• Verified date: September 2018
• Source: University of Parma
• Contact: Elena Giovanna Bignami, MD
• Phone: +39 0525033609
• Email: elenagiovanna.bignami[@]unipr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• informed consent signature

• age > 18 years

Exclusion Criteria:

• Age> 90 years

• Cianoacrilate allergy

• Presence of bacteraemia

• Informed consent refusal

Related Conditions & MeSH terms

• Central Venous Catheter

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria di Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Systemic infection	Rate of systemic infections will be evaluated by evaluating the presence of fever	15 days