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The Effect of Plasma-air-filtration on the Incidence of Surgical Site Infections in Orthopaedic Surgery

NCT02695368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45000

Last updated 2022-06-24

No results posted yet for this study

Summary

The study is a multicenter, double-blind, randomized, controlled trial conducted at six major university and teaching hospitals with a catchment population of approximately 2 million. In the current study it has been hypothesized that a non-invasive air cleaner utilizing a plasma chamber can significantly reduce the incidence of surgical site infections (SSIs).

Conditions

  • Orthopaedic Surgery (30 Minutes or Longer)

Interventions

DEVICE

Novaerus NV800 on

The air-cleaner sterilizes the air particles through a plasma chamber. Air in the operating theatre is pumped through the chamber (80 - 380 m3/Hr) and by using a small current it transforms the gas in the vicinity of the electrode into plasma and eradicates any bacteria that pass through. The air-cleaner has to have been turned on for at least 2 days prior to the surgical intervention.

DEVICE

Novaerus NV800 off

The machine decribed above is running but the plasma filter chamber isn't active, i.e. the placebo group.

DEVICE

Novaerus NV800 on or off

Patients with multiple surgeries that have been operated during both periods when the apparatus has been on and off will belong to this mixed group.

Sponsors & Collaborators

Principal Investigators

  • Max Gordon, M.D, PhD · Danderyd Hospital, Stockholm, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02695368 on ClinicalTrials.gov