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CompletedNCT04617353Updated Jun 24, 2026

Combined Air-plasma Flow and Nitric Oxide Therapy in Cardiac Surgery

An interventional study of NO-based treatment of sterno-mediastinitis and Treatment of sterno-mediastinitis in Mediastinitis, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Completed at 1 site in Russia. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

In cardiovascular surgery, the most common and serious complication is postoperative wound infection. The most formidable wound complication is mediastinitis, the frequency of which varies from 1 to 3%. Currently, mortality in this group of patients varies from 3.5 to 58.3%. In this regard, the relevance of developing new methods for the prevention and treatment of infectious wound complications is beyond doubt. In this study, it is supposed to examine and evaluate the effectiveness of the combined effects of air-plasma flow and nitric oxide in the treatment of postoperative infectious complications in cardiac surgery.

Read the detailed description

One of the most common and serious complications in cardiovascular surgery is sternal wound infection. According to many authors, the incidence of infectious complications after sternotomy ranges from 0.4% to 15% . Superficial infection of the anterior chest wall after median sternotomy occurs in 0.4-15% . Typically, this complication is detected within the first two weeks (on average, about seven days). The most formidable wound infectious complication is mediastinitis. According to various authors, the incidence of mediastinitis varies from 1 to 3%. Mortality in this group of patients reaches 39% . Until now, the only effective and generally accepted method for treating patients with mediastinitis has been antibiotic therapy in combination with surgical intervention. The options for antibiotic therapy remain generally accepted and their effectiveness is not discussed, however, there are many options for various types of surgical treatment. Their main principle is to perform resternotomy, necrosectomy, followed by reosteosynthesis of the sternum and the installation of permanent irrigation and aspiration, flow-through drainage. Despite this, the mortality rate in this pathology remains invariably high. In this regard, issues related to the development of new medical technologies, methods for prevention and treatment of infectious wound complications do not lose their relevance at the present time.

During the study, it is supposed to use an original method developed for the prevention, as well as for the treatment of wound infectious complications.

The advantage of the investigator's proposed original method of treating mediastinitis is in the combined effect of thermal (air-plasma flow) and biochemical (effect of NO on wound surfaces) by stimulating the processes of regeneration and repair.

Also, for obvious reasons, resistance cannot arise to it, which is relevant in the context of the widespread transmission of nosocomial infections, especially in large hospitals, such as modern cardiology dispensaries.

As a result of the work, the cases of infectious wound complications in the early postoperative period, the total number of bed-days spent, the time spent in the ICU, the duration of mechanical ventilation, laboratory parameters: red blood cell count, coagulation system, markers of infection and inflammation, state of sepsis, determination of how fast the bone tissue reparation is, CT scan of the chest, sternum, examination of the bacterial flora and bacterial contamination of the postoperative wound will be assessed.

02

Conditions studied

  • Mediastinitis

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Keywords

  • plasma
  • endogenous nitric oxide
  • infectious complications
  • mediastinitis
03

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who underwent heart and great vessels surgery with confirmed laboratory, bacteriological, instrumental tests, as well as the presence of clinical signs of sterno-mediastinitis.
  • Signed informed consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Patients who underwent heart and great vessels surgery not through a median sternotomy.
  • Patients who have signs of inconsistency of sutures or any other wound complications, but there are no clinical, laboratory, bacteriological data indicating infection of the postoperative wound.
  • No informed consent to participate in the study.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Plasma

    (the treatment of sterno-mediastinitis was carried out using a combined method of air-plasma flow and NO therapy)

    Procedure: NO-based treatment of sterno-mediastinitis

  • Other
    Standard therapy

    (patients who were treated for sterno-mediastinitis according to clinical guidelines, the main method of which is a permanent irrigation and aspiration flow drainage method, as well as a Vacuum Assisted Closure (VAC) system of dressings for vacuum drainage)

    Procedure: Treatment of sterno-mediastinitis

Interventions

  • ProcedureNO-based treatment of sterno-mediastinitis

    Preparation of a postoperative wound in case of infectious complications. A mandatory sampling material for culture and antibiotic sensitivity is collected before and after the air plasma flow treatment. Direct effect of the air-plasma flow on the entire wound surface in sterilization mode with an exposure of 2-3 minutes for each surgical wound, until the level of bacterial contamination decreases to 10-5 and below. The technique of using air-plasma flow when closing a wound after preventing infectious complications in it. In the postoperative period, daily air-plasma flow treatment in sterilization mode along the suture line for 3 minutes. Penetrating drainage NO supply in the biological stimulation mode daily for 10 days, with an exposure of 1-2 minutes up to 10 days, with a volume of up to 2 liters per minute. Collecting wound culture from the drainage containers on 1-3-7-12 days to detect pathogens and the bacterial number.

  • ProcedureTreatment of sterno-mediastinitis

    patients who were treated for sterno-mediastinitis according to clinical guidelines, the main method of which is a permanent irrigation and aspiration flow drainage method, as well as a Vacuum Assisted Closure (VAC) system of dressings for vacuum drainage

05

What researchers measure

Primary outcomes

  1. Death

    In-hospital mortality rate (%)

    Time frame: 30 days

  2. Re-infection of the wound

    Rate wound re-infection (%)

    Time frame: 30 days

  3. Skin suture incompetence

    Rate of skin suture incompetence (%) due to lack of tissue repair

    Time frame: 30 days

  4. Recovery

    Rate of full recovery (%)

    Time frame: 30 days

06

Study locations

1 site
  • TomskNRMC
    Tomsk, Tomskay Oblast 634012, Russia
07

References and documents

Individual participant data

Plan to share: Yes — Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04617353
Lead sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Responsible party
Sponsor
First posted
Nov 5, 2020
Start date
Mar 14, 2017
Primary completion
Dec 20, 2021
Completion
Dec 20, 2023
Last update
Jun 24, 2026

Study contacts

Mikhail Kuznetsov, PhD
study chair · Tomsk National Research Medical Center of the Russian Academy of Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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