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

June 23, 2026 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

Experience With the Combined Method of Air-plasma Flow and Nitric Oxide Therapy in the Prevention and Treatment of Wound Infectious Complications in Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
    • Tomskay Oblast
      • Tomsk, Tomskay Oblast, Russia, 634012
        • TomskNRMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 30 days
In-hospital mortality rate (%)
30 days
Re-infection of the wound
Time Frame: 30 days
Rate wound re-infection (%)
30 days
Skin suture incompetence
Time Frame: 30 days
Rate of skin suture incompetence (%) due to lack of tissue repair
30 days
Recovery
Time Frame: 30 days
Rate of full recovery (%)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Study Chair: Mikhail Kuznetsov, PhD, Tomsk National Research Medical Center of the Russian Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2017

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRI-192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.

IPD Sharing Access Criteria

Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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