Trial reportInternational orthopaedics2021
Efficacy of surgical helmet systems for protection against COVID-19: a double-blinded randomised control study.
Trial report in International orthopaedics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Interleukin-6 blocking agents for treating COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2021Pooled it
- The use of a surgical helmet system with a high-efficiency particulate air filter as possible protection equipment during the coronavirus disease 2019 pandemic: a double-blinded randomized control study.International orthopaedics · 2022Trial
- Reintroduction of Hip and Knee Arthroplasty Through COVID-19 Pandemic: Experience at a High-Volume Hip and Knee Arthroplasty Centre in India.Indian journal of orthopaedics · 2023Article
- Personal protection equipment for orthopaedic and trauma surgery during the COVID-19 pandemic: The results of an EFORT survey initiative.EFORT open reviews · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study assesses whether sterile surgical helmet systems (SSHS) provide surgeons with additional protection from aerosol pathogens alongside their traditional role protecting against splash. There has been debate on whether to use such systems in reopening elective orthopaedic surgery during the current COVID-19 pandemic environment.
methodsThirty-five participants were enrolled in a double-blinded randomised controlled study investigating efficacy of the Stryker Flyte Surgical Helmet (Stryker Corporation, Kalamazoo, MI, USA) as protection against respiratory droplets. Wearing the SSHS in a fit testing hood, subjects were randomised to nebulised saccharin solution or placebo. Twenty were allocated to the saccharin group with 15 to placebo. Positive sweet taste represented a failure of the test. Taste tests were performed with the helmet fan turned on and off.
resultsSSHS did not prevent saccharin taste (p < 0.0001). Within the saccharin cohort, 40% recorded a positive taste with the fan on and 100% with the fan off. There was a statistically significant difference in mean time-to-taste saccharin (p = 0.049) comparing fan on (123.5 s) vs. off (62.6 s).
conclusionsSSHS do not protect against aerosol particulate and therefore are not efficacious in protection against COVID-19. The fan system employed may even increase risk to the surgeon by drawing in particulates as well as delay recognition of intraoperative cues, such as exhaust from diathermy, that point to respirator mask leak.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.