N/A
N=450
Prospective Observational Study of the Power PICC Family of Devices and Accessories
Peripherally Inserted Central Catheter
Bottom Line
View on ClinicalTrials.gov: NCT04263649 ↗Enrolled (actual)
450
Serious AEs
12.9%
Results posted
Aug 2024
Primary outcome: Primary: Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access. — 1.6 % of subjects after PICC placement
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Peripherally Inserted Central Catheter (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Becton, Dickinson and Company
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access. |
1.6 | — |
| PRIMARY Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period. |
81.8 | — |
| SECONDARY Secondary Safety: Incidence of Phlebitis |
— | — |
| SECONDARY Secondary Safety: Incidence of Extravasation |
— | — |
| SECONDARY Secondary Safety: Incidence of Local Infection |
4.5 | — |
| SECONDARY Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection |
3.1 | — |
| SECONDARY Secondary Safety: Incidence of Catheter-related Bloodstream Infection. |
1.6 | — |
| SECONDARY Secondary Safety: Incidence of Accidental Dislodgement. |
3.8 | — |
| SECONDARY Secondary Safety: Incidence of Vessel Laceration. |
0.4 | — |
| SECONDARY Secondary Safety: Incidence of Vessel Perforation. |
0.2 | — |
| SECONDARY Secondary Performance: Percent of Patent Catheters |
93.9 | — |
| SECONDARY Secondary Performance: Percent of Placement Success in Single Insertion Attempt |
90.4 | — |
| SECONDARY Secondary Performance - Usability: Ease of Insertion |
419; 448; 425; 448; 448; 425 | — |
Summary
Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.
Eligibility Criteria
Inclusion Criteria
- Any patient, regardless of age or gender, for which the investigator has decided that one of the PowerPICC study devices for either short-or long-term venous access should be inserted as standard of care
- Expected to be available for observation through the duration of PICC therapy (including outpatient therapy, if applicable)
- Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.)
Exclusion Criteria
- Presence of any device-related infection, bacteremia, or septicemia is known or suspected
- Body size is insufficient to accommodate the size of implanted device
- Known or suspected to be allergic to materials contained in the device
- History of irradiation of prospective insertion site
- Previous episode(s) of venous thrombosis or vascular surgical procedures at the prospective placement site
- Local tissue factors which would prevent proper device stabilization and/or access
Data sourced from ClinicalTrials.gov (NCT04263649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.