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

NCT06506032 | Completed

• 2 other identifiers: KCH-24-DSWI-vanko06/RVO-FNOs/2021
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 5

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.

Conditions

Post-Sternotomy Deep Sternal Wound Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identification of pre-, intra-, and postoperative risk factors for deep sternal wound infection (DSWI) development

  3 days

• Recurrence of DSWI

  1- year follow-up

• Determination of mortality

  1- year follow-up

Study Arms (2)

Patients treated with NPWT with DSWI

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

Drug: Intravenous Vancomycin administration

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

Interventions

Intravenous Vancomycin administration DRUG

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

Patients treated with NPWT with DSWI

Standard postoperative therapy OTHER

The patients received standard postoperative therapy

Patients without DSWI after cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with deep sternal wound infection after open-heart surgery

You may qualify if:

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

You may not qualify if:

• \- none

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University of Ostrava: collaborator
• Masaryk University: collaborator
• Masaryk Memorial Cancer Institute: collaborator
• Technical University of Ostrava: collaborator

Study Sites (5)

University of Ostrava

Ostrava, Moravian-Silesian Region, 703 00, Czechia

Location

Technical University of Ostrava

Ostrava, Moravian-Silesian Region, 708 00, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Masaryk University

Brno, South Moravian, 625 00, Czechia

Location

Masaryk Memorial Cancer Institute

Brno, South Moravian, 656 63, Czechia

Location

Related Publications (6)

• 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.

  PMID: 35618048 BACKGROUND

• 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.

  PMID: 19880326 BACKGROUND

• 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.

  PMID: 30604928 BACKGROUND

• 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.

  PMID: 24674131 BACKGROUND

• 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.

  PMID: 28224048 BACKGROUND

• Kolek M, Duricova J, Brozmanova H, Sistik P, Jurica J, Kankova K, Motyka O, Kacirova I. Vancomycin wound penetration in open-heart surgery patients receiving negative pressure wound therapy for deep sternal wound infection. Ann Med. 2025 Dec;57(1):2444544. doi: 10.1080/07853890.2024.2444544. Epub 2024 Dec 23.

  PMID: 39711425 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and exudate samples

Study Officials

• Martin Kolek, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 17, 2024
• Study Start: July 30, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5)