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

Completed

• Conditions: Post-Sternotomy Deep Sternal Wound Infection
• Interventions: Drug: Intravenous Vancomycin administration; Other: Standard postoperative therapy

• Registration Number: NCT06506032
• Lead Sponsor: University Hospital Ostrava

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.

Study Timeline

• Study Start: 2021-07-30
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-06-28
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-17
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with NPWT with DSWI	Intravenous Vancomycin administration	Patients with deep sternal wound infection were enrolled in this study group.
Patients without DSWI after cardiac surgery	Standard postoperative therapy	Patients without deep sternal wound infection after cardiac surgery were enrolled in this study group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Recurrence of DSWI	1- year follow-up	The investigators will assess the recurrence of DSWI in the study subjects.
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.
Determination of mortality	1- year follow-up	The investigators will assess the in-hospital, 90-day, and all-cause mortality in the study subjects.

Trial Locations

Locations (5)

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 Region, Czechia

Masaryk Memorial Cancer Institute; 🇨🇿 Brno, South-Moravian Region, Czechia