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

University Hospital Ostrava

Status: Completed

Conditions: Post-Sternotomy Deep Sternal Wound Infection

Treatments: Other: Standard postoperative therapy; Drug: Intravenous Vancomycin administration

Study type: Observational

Funder types: Other

Identifiers

NCT06506032

KCH-24-DSWI-vanko

06/RVO-FNOs/2021 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

10 participants in 2 patient groups

Patients treated with NPWT with DSWI

Description:

Patients with deep sternal wound infection were enrolled in this study group.

Treatment:

Drug: Intravenous Vancomycin administration

Patients without DSWI after cardiac surgery

Description:

Patients without deep sternal wound infection after cardiac surgery were enrolled in this study group.

Treatment:

Other: Standard postoperative therapy