Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT01770067
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
Sponsor:
Hillel Yaffe Medical Center
Organization:
Study Overview
Official Title:
Prospective Evaluation of the Efficacy and Safety of Continuous In-situ Ultra High-dose Antibiotics (CITA) and Minimally Invasive Surgery (MIS) Utilizing Regulated Negative Pressure-assisted Wound Therapy (RNPT) in the Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of previously treated CIEDs, immuno-compromised patients, and others.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: