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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2017
CompletedFirst Submitted
Initial submission to the registry
October 30, 2020
CompletedFirst Posted
Study publicly available on registry
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedMarch 1, 2024
February 1, 2024
4.8 years
October 30, 2020
February 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Plasma
EXPERIMENTAL(the treatment of sterno-mediastinitis was carried out using a combined method of air-plasma flow and NO therapy)
Standard therapy
OTHER(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)
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TomskNRMC
Tomsk, Tomskay Oblast, 634012, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mikhail Kuznetsov, PhD
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2020
First Posted
November 5, 2020
Study Start
March 14, 2017
Primary Completion
December 20, 2021
Study Completion
December 20, 2023
Last Updated
March 1, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.