NCT06506032

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Post-Sternotomy Deep Sternal Wound Infection

Interventions

Type	Name	Description
DRUG	Intravenous Vancomycin administration	Vancomycin was administered to the patients at the discretion of the physician
OTHER	Standard postoperative therapy	The patients received standard postoperative therapy

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-07-17
• Last updated: 2024-07-22

Locations

5 sites across 1 country: Czechia