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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06506032

Enrollment

Registered

2024-07-17

Start date

2021-07-30

Completion date

2023-12-31

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Sternotomy Deep Sternal Wound Infection

Keywords

Exudate, Deep Sternal Wound Infection, Negative Pressure Wound Therapy, Open-Heart Surgery, Vancomycin, Wound Penetration

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.

Interventions

DRUGIntravenous Vancomycin administration

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

OTHERStandard postoperative therapy

The patients received standard postoperative therapy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

\- none

Design outcomes

Primary

Measure	Time frame	Description
Vancomycin penetration into exudate	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

Measure	Time frame	Description
Identification of pre-, intra-, and postoperative risk factors for deep sternal wound infection (DSWI) development	3 days	The investigators will identify independent risk factors for DSWI by comparing patients with and without DSWI after cardiac surgery.
Recurrence of DSWI	1- year follow-up	The investigators will assess the recurrence of DSWI in the study subjects.
Determination of mortality	1- year follow-up	The investigators will assess the in-hospital, 90-day, and all-cause mortality in the study subjects.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026