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.
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.
Study Type
OBSERVATIONAL
Enrollment
10
Vancomycin was administered to the patients at the discretion of the physician
The patients received standard postoperative therapy
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
Vancomycin penetration into exudate
To determine the vancomycin penetration into the wound during NPWT, the investigators compared the vancomycin total (bound + unbound) average exudate concentration to the vancomycin total (bound + unbound) average serum concentration on the first study day. The same calculation was used to determine the penetration ratio for free (unbound) vancomycin concentrations on the first study day. For samples from three consecutive days, the investigators compared the vancomycin total (bound + unbound) through exudate concentrations with the vancomycin total (bound + unbound) through serum concentrations. The same calculation was used to determine the penetration ratio for free (unbound) vancomycin concentrations on three consecutive days.
Time frame: repeated measurements for the total of 72 hours
Identification of pre-, intra-, and postoperative risk factors for deep sternal wound infection (DSWI) development
The investigators will identify independent risk factors for DSWI by comparing patients with and without DSWI after cardiac surgery.
Time frame: 3 days
Recurrence of DSWI
The investigators will assess the recurrence of DSWI in the study subjects.
Time frame: 1- year follow-up
Determination of mortality
The investigators will assess the in-hospital, 90-day, and all-cause mortality in the study subjects.
Time frame: 1- year follow-up
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