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

U

University of Parma

Status

Unknown

Conditions

Central Venous Catheter

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT03801811
382/2018/DISP/AOUPR

Details and patient eligibility

About

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.

Full 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

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • informed consent signature
  • age > 18 years

Exclusion criteria

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

Trial contacts and locations

1

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Central trial contact

Elena Giovanna Bignami, MD

Data sourced from clinicaltrials.gov

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