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NCT01770067

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 NA Last updated 26 January 2022
What this trial tests

NA trial testing CITA-RNPT in Infection in 100 participants. Status unknown.

Timeline
1 February 2013
Primary endpoint
1 February 2023
1 February 2023

Quick facts

Lead sponsorHillel Yaffe Medical Center
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment100
Start date1 February 2013
Primary completion1 February 2023
Estimated completion1 February 2023
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Hillel Yaffe Medical Center

Who can join

15 and older, any sex, with Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Negative pressure wound therapy for surgical wounds healing by primary closure.
    Webster J, Liu Z, Norman G, Dumville JC, et al · · 2019 · cited 73× · PMID 30912582 · DOI 10.1002/14651858.cd009261.pub4
  2. Negative pressure wound therapy for surgical wounds healing by primary closure.
    Norman G, Shi C, Goh EL, Murphy EM, et al · · 2022 · cited 71× · PMID 35471497 · DOI 10.1002/14651858.cd009261.pub7
  3. Negative pressure wound therapy for surgical wounds healing by primary closure.
    Norman G, Goh EL, Dumville JC, Shi C, et al · · 2020 · cited 48× · PMID 32542647 · DOI 10.1002/14651858.cd009261.pub6
  4. Negative pressure wound therapy for surgical wounds healing by primary closure.
    Norman G, Goh EL, Dumville JC, Shi C, et al · · 2020 · cited 38× · PMID 32356396 · DOI 10.1002/14651858.cd009261.pub5
  5. Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections.
    Topaz M, Chorin E, Schwartz AL, Hochstadt A, et al · · 2023 · cited 26× · PMID 36631206 · DOI 10.1016/j.jacc.2022.10.022

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Other recruiting trials for Infection

Currently open trials in the same condition.

Other Hillel Yaffe Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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