Post-Sternotomy Deep Sternal Wound InfectionNCT06506032
Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection
An observational study of Post-Sternotomy Deep Sternal Wound Infection, run by University Hospital Ostrava at 5 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Sternotomy Deep Sternal Wound Infection
- What is being tested?
- Intravenous Vancomycin administration and Standard postoperative therapy
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 5 sitesCzechia
- Study dates
- 30 Jul 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with deep sternal wound infection after open-heart surgery
Who may be able to join
- age ≥ 18 years
- clinical and laboratory signs of significant infection
- indication for NPWT with concomitant antibiotic therapy
Who cannot join
- none
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Czechia5 sites
Masaryk University
Brno, South Moravian, 625 00
Masaryk Memorial Cancer Institute
Brno, South Moravian, 656 63
University of Ostrava
Ostrava, Moravian-Silesian Region, 703 00
Technical University of Ostrava
Ostrava, Moravian-Silesian Region, 708 00
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
Official title: 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.
Read the 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.
- Being tested
- Intravenous Vancomycin administration, Standard postoperative therapy
- Keywords
- Exudate, Deep Sternal Wound Infection, Negative Pressure Wound Therapy, Open-Heart Surgery, Vancomycin, Wound Penetration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Vancomycin administrationDrug
Vancomycin was administered to the patients at the discretion of the physician
Standard postoperative therapyOther
The patients received standard postoperative therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with NPWT with DSWI | Patients with deep sternal wound infection were enrolled in this study group. Receives: 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. Receives: Other: Standard postoperative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The investigators will identify independent risk factors for DSWI by comparing patients with and without DSWI after cardiac surgery.
Measured: 3 days
Recurrence of DSWI
The investigators will assess the recurrence of DSWI in the study subjects.
Measured: 1- year follow-up
Determination of mortality
The investigators will assess the in-hospital, 90-day, and all-cause mortality in the study subjects.
Measured: 1- year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start30 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Sternotomy Deep Sternal Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ostrava, Masaryk University, Masaryk Memorial Cancer Institute, Technical University of Ostrava
- Responsible party
- Sponsor
- Investigators
- Martin Kolek, MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506032
- Sponsor's protocol ID
- KCH-24-DSWI-vanko
- Other IDs
- 06/RVO-FNOs/2021
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
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.
PubMed 35618048Baillot 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.
PubMed 19880326Polykandriotis 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.
PubMed 30604928Ida 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.
PubMed 24674131Rowan 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.
PubMed 28224048Kolek 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.
PubMed 39711425
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect and Wound Penetration of Vancomycin in Open-heart Surgery Patients Receiving Negative Pressure Wound Therapy for Deep Sternal Wound Infection
- ClinicalTrials.gov ID
- NCT06506032
- Acronym / sponsor ID
- KCH-24-DSWI-vanko
- Keywords
- Exudate, Deep Sternal Wound Infection, Negative Pressure Wound Therapy, Open-Heart Surgery, Vancomycin, Wound Penetration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University of Ostrava, Masaryk University, Masaryk Memorial Cancer Institute, Technical University of Ostrava
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with NPWT with DSWI | – | Drug: Intravenous Vancomycin administrationPatients with deep sternal wound infection were enrolled in this study group. |
| Patients without DSWI after cardiac surgery | – | Other: Standard postoperative therapyPatients without deep sternal wound infection after cardiac surgery were enrolled in this study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with deep sternal wound infection after open-heart surgery
Key inclusion criteria (3 listed)
- age ≥ 18 years
- clinical and laboratory signs of significant infection
- indication for NPWT with concomitant antibiotic therapy
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Vancomycin administrationVancomycin was administered to the patients at the discretion of the physician | Drug | Patients treated with NPWT with DSWI |
| Standard postoperative therapyThe patients received standard postoperative therapy | Other | Patients without DSWI after cardiac surgery |
Primary outcome
Vancomycin penetration into exudate
Time frame: 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.
3 secondary outcomes
Identification of pre-, intra-, and postoperative risk factors for deep sternal wound infection (DSWI) development
Time frame: 3 days
Recurrence of DSWI
Time frame: 1- year follow-up
Determination of mortality
Time frame: 1- year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 35618048Perezgrovas-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.
- Background: PubMed 19880326Baillot 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.
- Background: PubMed 30604928Polykandriotis 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.
- Background: PubMed 24674131Ida 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.
- Background: PubMed 28224048Rowan 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.
- Derived from this study: PubMed 39711425Kolek 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Kolek, MD,PhD principal investigator
University Hospital Ostrava
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Sternotomy Deep Sternal Wound Infection, run by University Hospital Ostrava at 5 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancomycin penetration into exudate (time frame: repeated measurements for the total of 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06506032, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.