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

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: Mediastinitis
• Intervention / Treatment: Procedure: NO-based treatment of sterno-mediastinitis; Procedure: Treatment of sterno-mediastinitis

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

Study Locations

• Russian Federation
  • Tomskay Oblast
    • Tomsk, Tomskay Oblast, Russian Federation, 634012
      • TomskNRMC

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• 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

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): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: plasma; mediastinitis; infectious complications; endogenous nitric oxide
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Mediastinal Diseases; Thoracic Diseases; Mediastinitis
• Other Study ID Numbers: TomskNRMC

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