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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Central Venous Catheter

Intervention / Treatment
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* Procedure: Study of the efficacy of using skin glue in the application of Port a cath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent signature age > 18 years Exclusion Criteria: Age> 90 years Cianoacrilate allergy Presence of bacteraemia Informed consent refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Systemic infection | Rate of systemic infections will be evaluated by evaluating the presence of fever | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Port, Glue, CVC