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NCT05880420 Clinical Trial

EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE)TELEHEALTH HOME MEDICATION VS/OUTPATIENT MEDICATION OF CENTRAL VENOUS CATHETER PICC (PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER)

Infections Clinical Trial

— ARCO  

Official title:
EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE) TELEASSISTED HOME DRESSING VS/ OUTPATIENT DRESSING OF PICC CENTRAL VENOUS CATHETER (PERIPHERAL INSERTION CENTRAL VENOUS CATHETER)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05880420
Other study ID # RS1518/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2021
Est. completion date August 16, 2021

Study information
Verified date June 2023
Source Regina Elena Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cancer patients need central venous access according to the different types of chemotherapy and support drugs for their treatment path. The presence of a central vascular access brings mechanical issues, thrombotic and infectious complications that can undermine the patient's health and the life of the catheter, therefore the management of venous accesses is clinically relevant. The prevention of infections remains mainly based on correct hand washing and compliance with aseptic techniques. This is a multicenter intervention study is composed by a single experimental arm (home) and a calibration arm (outpatient). The study is designed to evaluate that the complication rate recorded in the two groups are similar.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date August 16, 2021
Est. primary completion date August 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Share patient choice - availability at the patient's home at least once a week - availability during on line appointment time with the tutor/video

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Caregiver operations with medication accessories
After at least an initial outpatient medication (24/72 hours), home medication every 7 days (caregiver) for a total of 10 weeks.
• Nurse operations with medication accessories
Outpatient medication every week (for a total of 10 weeks). Patients adhering to this arm will be followed at the IGAV nursing clinic of the IFOs.

Locations
Country Name City State
Italy "Regina Elena" National Cancer Institute Rome

Sponsors (2)
Lead Sponsor Collaborator
Regina Elena Cancer Institute Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acceptability To compare the incidence of complications found in peripherally inserted central venous catheter (PICC) management in outpatient (calibration arm) vs home management to test the hypothesis that the incidence of catheter-related complications in the home management group is not higher than that observed in the outpatient group. 10 weeks
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