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COMPLETED
NCT04617353
NA

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

Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2017-03-14

Completion Date

2023-12-20

Last Updated

2026-06-24

Healthy Volunteers

No

Conditions

Interventions

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.

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

Locations (1)

TomskNRMC

Tomsk, Tomskay Oblast, Russia