Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection
NCT ID: NCT06506032
Last Updated: 2024-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2021-07-30
2023-12-31
Brief Summary
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In the present study, the investigators will evaluate the pharmacokinetic profile and wound penetration of vancomycin in open-heart surgery patients with post-sternotomy deep sternal wound infection receiving NPWT.
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Detailed Description
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The ratio of average vancomycin concentration in wound exudate to serum will be observed for free (unbound) and for total (bound + unbound) concentration. The percentage of free vancomycin in wound exudate and in serum will be observed. The level of vancomycin wound penetration will be observed for three days. The total hospital stay in patients with DSWI versus those without DSWI will be recorded, together with the in-hospital or 90-day mortality, together with late DSWI recurrence. All-cause mortality will be analyzed during a median follow-up of 2.5 years.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients treated with NPWT with DSWI
Patients with deep sternal wound infection were enrolled in this study group.
Intravenous Vancomycin administration
Vancomycin was administered to the patients at the discretion of the physician
Patients without DSWI after cardiac surgery
Patients without deep sternal wound infection after cardiac surgery were enrolled in this study group.
Standard postoperative therapy
The patients received standard postoperative therapy
Interventions
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Intravenous Vancomycin administration
Vancomycin was administered to the patients at the discretion of the physician
Standard postoperative therapy
The patients received standard postoperative therapy
Eligibility Criteria
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Inclusion Criteria
* clinical and laboratory signs of significant infection
* indication for NPWT with concomitant antibiotic therapy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Ostrava
OTHER
Masaryk University
OTHER
Masaryk Memorial Cancer Institute
OTHER
Technical University of Ostrava
UNKNOWN
University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Martin Kolek, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University of Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Technical University of Ostrava
Ostrava, Moravian-Silesian Region, Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Masaryk University
Brno, South Moravian, Czechia
Masaryk Memorial Cancer Institute
Brno, South Moravian, Czechia
Countries
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References
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Perezgrovas-Olaria R, Audisio K, Cancelli G, Rahouma M, Ibrahim M, Soletti GJ, Chadow D, Demetres M, Girardi LN, Gaudino M. Deep Sternal Wound Infection and Mortality in Cardiac Surgery: A Meta-analysis. Ann Thorac Surg. 2023 Jan;115(1):272-280. doi: 10.1016/j.athoracsur.2022.04.054. Epub 2022 May 23.
Baillot R, Cloutier D, Montalin L, Cote L, Lellouche F, Houde C, Gaudreau G, Voisine P. Impact of deep sternal wound infection management with vacuum-assisted closure therapy followed by sternal osteosynthesis: a 15-year review of 23,499 sternotomies. Eur J Cardiothorac Surg. 2010 Apr;37(4):880-7. doi: 10.1016/j.ejcts.2009.09.023. Epub 2009 Oct 31.
Polykandriotis E, Horch RE, Jost M, Arkudas A, Kees F, Schmitz M. Can systemically administered antibiotics be detected in wound tissues and surfaces under negative pressure wound therapy? Int Wound J. 2019 Apr;16(2):503-510. doi: 10.1111/iwj.13063. Epub 2019 Jan 3.
Ida Y, Matsumura H, Onishi M, Ono S, Imai R, Watanabe K. Measurement of vancomycin hydrochloride concentration in the exudate from wounds receiving negative pressure wound therapy: a pilot study. Int Wound J. 2016 Apr;13(2):204-8. doi: 10.1111/iwj.12260. Epub 2014 Mar 28.
Rowan MP, Niece KL, Rizzo JA, Akers KS. Wound Penetration of Cefazolin, Ciprofloxacin, Piperacillin, Tazobactam, and Vancomycin During Negative Pressure Wound Therapy. Adv Wound Care (New Rochelle). 2017 Feb 1;6(2):55-62. doi: 10.1089/wound.2016.0698.
Kolek M, Duricova J, Brozmanova H, Sistik P, Jurica J, Kankova K, Motyka O, Kacirova I. Vancomycin wound penetration in open-heart surgery patients receiving negative pressure wound therapy for deep sternal wound infection. Ann Med. 2025 Dec;57(1):2444544. doi: 10.1080/07853890.2024.2444544. Epub 2024 Dec 23.
Other Identifiers
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06/RVO-FNOs/2021
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KCH-24-DSWI-vanko
Identifier Type: -
Identifier Source: org_study_id
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