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NCT Number: NCT06506032

Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection

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.

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Key information

Conditions

Post-Sternotomy Deep Sternal Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Technical University of Ostrava, Ostrava, Moravian-Silesian Region, Czechia

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Intravenous Vancomycin administration

Drug

Vancomycin was administered to the patients at the discretion of the physician

Standard postoperative therapy

Other

The patients received standard postoperative therapy

Primary outcomes

  1. Vancomycin penetration into exudate

    Time frame: repeated measurements for the total of 72 hours

    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.

Secondary outcomes

  1. Identification of pre-, intra-, and postoperative risk factors for deep sternal wound infection (DSWI) development

    Time frame: 3 days

    The investigators will identify independent risk factors for DSWI by comparing patients with and without DSWI after cardiac surgery.

  2. Recurrence of DSWI

    Time frame: 1- year follow-up

    The investigators will assess the recurrence of DSWI in the study subjects.

  3. Determination of mortality

    Time frame: 1- year follow-up

    The investigators will assess the in-hospital, 90-day, and all-cause mortality in the study subjects.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Masaryk Memorial Cancer Institute
  • Masaryk University
  • Technical University of Ostrava
  • University of Ostrava

Registry information

Official study title

Clinical Effect and Wound Penetration of Vancomycin in Open-heart Surgery Patients Receiving Negative Pressure Wound Therapy for Deep Sternal Wound Infection

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.