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

• ClinicalTrials.gov Identifier: NCT04617353
• Recruitment Status: Recruiting
• First Posted: November 5, 2020
• Last Update Posted: January 24, 2022
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Information provided by (Responsible Party): Tomsk National Research Medical Center of the Russian Academy of Sciences

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Mediastinitis	Procedure: NO-based treatment of sterno-mediastinitis; Procedure: Treatment of sterno-mediastinitis	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Patient enrollment according to the inclusion criteria. Carrying out medical manipulations according to the group inclusion criteria. Efficiency control based on the clinical course of the disease, instrumental and laboratory study methods.

After the patient is discharged from the hospital, a follow-up examination after 12 months, including an objective examination, a spiral computed tomography of the chest organs. Complete blood count, general urine test, biochemistry blood test.

Comparison of the main clinical and laboratory parameters between patients of both groups: 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

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: March 14, 2017
• Actual Primary Completion Date: December 20, 2021
• Estimated Study Completion Date: December 20, 2023

Arms and Interventions

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.
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

Outcome Measures

Primary Outcome Measures :

1. Death [ Time Frame: 30 days ]
   In-hospital mortality rate (%)
2. Re-infection of the wound [ Time Frame: 30 days ]
   Rate wound re-infection (%)
3. Skin suture incompetence [ Time Frame: 30 days ]
   Rate of skin suture incompetence (%) due to lack of tissue repair
4. Recovery [ Time Frame: 30 days ]
   Rate of full recovery (%)

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Mikhail Kuznetsov, PhD; +79059925393; kms@cardio-tomsk.ru

Locations

Russian Federation

TomskNRMC; Recruiting

Tomsk, Tomskay Oblast, Russian Federation, 634012

Contact: Mikhail Kuznetsov, PhD +79059925393 kms@cardio-tomsk.ru

Sponsors and Collaborators

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

More Information

• Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
• ClinicalTrials.gov Identifier: NCT04617353
• Other Study ID Numbers: TomskNRMC
• First Posted: November 5, 2020
• Last Update Posted: January 24, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• 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.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:

plasma; endogenous nitric oxide; infectious complications; mediastinitis

Additional relevant MeSH terms:

Mediastinitis; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases