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

Not Applicable

Completed

• Conditions: Mediastinitis
• Interventions: Procedure: NO-based treatment of sterno-mediastinitis; Procedure: Treatment of sterno-mediastinitis

• Registration Number: NCT04617353
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

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.

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 Timeline

• Study Start: 2017-03-14
• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Primary Completion: 2021-12-20
• Study Completion: 2023-12-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasma	NO-based treatment of sterno-mediastinitis	(the treatment of sterno-mediastinitis was carried out using a combined method of air-plasma flow and NO therapy)
Standard therapy	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)

Primary Outcome Measures

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

Trial Locations

Locations (1)

TomskNRMC; 🇷🇺 Tomsk, Tomskay Oblast, Russian Federation