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

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.

Study Overview

• Status: Completed
• Conditions: Post-Sternotomy Deep Sternal Wound Infection
• Intervention / Treatment: Drug: Intravenous Vancomycin administration; Other: Standard postoperative therapy

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • University Hospital Ostrava
    • Ostrava, Moravian-Silesian Region, Czechia, 703 00
      • University of Ostrava
    • Ostrava, Moravian-Silesian Region, Czechia, 708 00
      • Technical University of Ostrava
  • South-Moravian Region
    • Brno, South-Moravian Region, Czechia, 625 00
      • Masaryk university
    • Brno, South-Moravian Region, Czechia, 656 63
      • Masaryk Memorial Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with deep sternal wound infection after open-heart surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

- none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with NPWT with DSWI; Patients with deep sternal wound infection were enrolled in this study group.	Drug: Intravenous Vancomycin administration; Vancomycin was administered to the patients at the discretion of the physician
Patients without DSWI after cardiac surgery; Patients without deep sternal wound infection after cardiac surgery were enrolled in this study group.	Other: Standard postoperative therapy; The patients received standard postoperative therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vancomycin penetration into exudate	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.	repeated measurements for the total of 72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: University of Ostrava; Technical University of Ostrava; Masaryk University; Masaryk Memorial Cancer Institute
• Investigators: Principal Investigator: Martin Kolek, MD,PhD, University Hospital Ostrava

Publications and helpful links

General Publications

• Perezgrovas-Olaria R, Audisio K, Cancelli G, Rahouma M, Ibrahim M, Soletti GJ, Chadow D, Demetres M, Girardi LN, Gaudino M. Deep Sternal Wound Infection and Mortality in Cardiac Surgery: A Meta-analysis. Ann Thorac Surg. 2023 Jan;115(1):272-280. doi: 10.1016/j.athoracsur.2022.04.054. Epub 2022 May 23.
• Baillot R, Cloutier D, Montalin L, Cote L, Lellouche F, Houde C, Gaudreau G, Voisine P. Impact of deep sternal wound infection management with vacuum-assisted closure therapy followed by sternal osteosynthesis: a 15-year review of 23,499 sternotomies. Eur J Cardiothorac Surg. 2010 Apr;37(4):880-7. doi: 10.1016/j.ejcts.2009.09.023. Epub 2009 Oct 31.
• Polykandriotis E, Horch RE, Jost M, Arkudas A, Kees F, Schmitz M. Can systemically administered antibiotics be detected in wound tissues and surfaces under negative pressure wound therapy? Int Wound J. 2019 Apr;16(2):503-510. doi: 10.1111/iwj.13063. Epub 2019 Jan 3.
• Ida Y, Matsumura H, Onishi M, Ono S, Imai R, Watanabe K. Measurement of vancomycin hydrochloride concentration in the exudate from wounds receiving negative pressure wound therapy: a pilot study. Int Wound J. 2016 Apr;13(2):204-8. doi: 10.1111/iwj.12260. Epub 2014 Mar 28.
• Rowan MP, Niece KL, Rizzo JA, Akers KS. Wound Penetration of Cefazolin, Ciprofloxacin, Piperacillin, Tazobactam, and Vancomycin During Negative Pressure Wound Therapy. Adv Wound Care (New Rochelle). 2017 Feb 1;6(2):55-62. doi: 10.1089/wound.2016.0698.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Vancomycin; Deep Sternal Wound Infection; Negative Pressure Wound Therapy; Exudate; Open-Heart Surgery; Wound Penetration
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: KCH-24-DSWI-vanko; 06/RVO-FNOs/2021 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No