Clinical trial NCT06506032: Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection
Official title: Clinical Effect and Wound Penetration of Vancomycin in Open-heart Surgery Patients Receiving Negative Pressure Wound Therapy for Deep Sternal Wound Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Sternotomy Deep Sternal Wound Infection
Keywords: Exudate
Deep Sternal Wound Infection
Negative Pressure Wound Therapy
Open-Heart Surgery
Vancomycin
Wound Penetration
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University of Ostrava
name: Masaryk University
name: Masaryk Memorial Cancer Institute
name: Technical University of Ostrava
First posted: 2024-07-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with deep sternal wound infection after open-heart surgery

Brief summary: Only a limited number of studies have been published that monitored the penetration of antibiotics from blood into exudate in patients treated with negative pressure wound therapy (NPWT), and that evaluated the adequacy of current dosage regimens according to antibiotic tissue concentrations. A higher migration rate of several antibiotics (including vancomycin) to exudate has been reported in patients with skin ulcers, skin defects, burns, and traumatic wounds treated with NPWT compared to patients without NPWT.

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.

Detailed description: For this prospective observational study, consecutive patients treated with NPWT for post-sternotomy deep sternal wound infection (DSWI) will be enrolled. On the first day of the study, serum and exudate samples will be synchronously collected at 0 (pre-dose), 0.5, 1, 2, 3, and 6 hours after vancomycin administration. On the following three consecutive days, additional samples will be collected, only before vancomycin administration.

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.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* clinical and laboratory signs of significant infection
* indication for NPWT with concomitant antibiotic therapy

Exclusion Criteria:

- none

Primary outcomes:
measure: Vancomycin penetration into exudate
timeFrame: repeated measurements for the total of 72 hours
Secondary outcomes:
measure: Identification of pre-, intra-, and postoperative risk factors for deep sternal wound infection (DSWI) development
timeFrame: 3 days
measure: Recurrence of DSWI
timeFrame: 1- year follow-up
measure: Determination of mortality
timeFrame: 1- year follow-up
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University of Ostrava
state: Moravian-Silesian Region
city: Ostrava
country: Czechia
facility: Technical University of Ostrava
state: Moravian-Silesian Region
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Brno
country: Czechia
facility: Masaryk University
state: South-Moravian Region
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
state: South-Moravian Region
Study officials:
affiliation: University Hospital Ostrava
name: Martin Kolek, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.