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

• Sponsor: University of Parma (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03801811
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 6.8
• Patients Per Site Per Month: 14.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Venous Catheter	Procedure: Study of the efficacy of using skin glue in the application of Port a cath

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Sep 5, 2018
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Apr 1, 2019

Outcome Measures

Primary Outcome Measures

1. visible presence of blood around the emergency site [24 hours]

   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.

Secondary Outcome Measures

1. Early infection of the emergency site; [7 days]

   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

2. Deischence of the surgical wound [15 days]

   Rate of dehiscence of the surgical wound. This will be assessed by looking for signs of bleeding, pain, fever and inflammation

3. Systemic infection [15 days]

   Rate of systemic infections will be evaluated by evaluating the presence of fever

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• informed consent signature

• age > 18 years

Exclusion Criteria:

• Age> 90 years

• Cianoacrilate allergy

• Presence of bacteraemia

• Informed consent refusal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera Universitaria di Parma	Parma		Italy	43126

Sponsors and Collaborators

• University of Parma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elena Giovanna Bignami, Professor, University of Parma
• ClinicalTrials.gov Identifier: NCT03801811
• Other Study ID Numbers: 382/2018/DISP/AOUPR
• First Posted: Jan 14, 2019
• Last Update Posted: Jan 14, 2019
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elena Giovanna Bignami, Professor, University of Parma: Port; Glue; CVC

Study Results

No Results Posted as of Jan 14, 2019