NCT01770067UnknownNot Applicable
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
Hillel Yaffe Medical Center1 site in 1 country100 target enrollmentStarted: February 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Lack of CIED Infection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •High-risk patients for CIED infections
- •CIED infections
Exclusion Criteria
- •Systematic infection
Arms & Interventions
Infected CIED and Infection-Prone Patients Prior to CIED Implantation
Experimental
Administration of high-dose antibiotics (CITA)
Intervention: CITA-RNPT (Drug)
Infected CIED extraction
Active Comparator
Extraction of infected CIED
Intervention: Extraction of infected CIED (Procedure)
Outcomes
Primary Outcomes
Lack of CIED Infection
Time Frame: One year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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