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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03801811
Acronym
Port glue cvc
Enrollment
100
Registered
2019-01-14
Start date
2018-09-05
Completion date
2019-04-30
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Catheter

Keywords

Port, Glue, CVC

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

Interventions

PROCEDUREStudy 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.

Sponsors

University of Parma
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* informed consent signature * age \> 18 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
visible presence of blood around the emergency site24 hoursEvaluate 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

MeasureTime frameDescription
Early infection of the emergency site;7 daysRate 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
Deischence of the surgical wound15 daysRate of dehiscence of the surgical wound. This will be assessed by looking for signs of bleeding, pain, fever and inflammation
Systemic infection15 daysRate of systemic infections will be evaluated by evaluating the presence of fever

Countries

Italy

Contacts

Primary ContactElena Giovanna Bignami, MD
elenagiovanna.bignami@unipr.it+39 0525033609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026