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

NCT03801811 | Unknown

• 1 other identifier: 382/2018/DISP/AOUPR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheter

Keywords

Port; Glue; CVC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Early infection of the emergency site;

  7 days

• Deischence of the surgical wound

  15 days

• Systemic infection

  15 days

Interventions

Study of the efficacy of using skin glue in the application of Port a cath PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critical ill patients

You may qualify if:

• informed consent signature
• age \> 18 years

You may not qualify if:

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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Azienda Ospedaliera Universitaria di Parma

Parma, 43126, Italy

RECRUITING

Central Study Contacts

Elena Giovanna Bignami, MD

CONTACT

+39 0525033609; elenagiovanna.bignami@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 14, 2019
• Study Start: September 5, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 14, 2019

Record last verified: 2018-09

Locations

IT (1)