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The Effect of Masks on Surgical Smoke Exposure

The Effect of Different Types of Masks on Surgical Smoke Exposure

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07161609
Enrollment
60
Registered
2025-09-08
Start date
2025-10-15
Completion date
2026-04-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Smoke

Keywords

Surgical smoke, Particle, Mask, Operating room team

Brief summary

Surgical smoke refers to the gaseous plume released into the air as a result of the thermal destruction of tissues by energy-based devices used in operating rooms. The composition of surgical smoke may include various organic compounds. In the literature, the most frequently identified chemical substances in surgical smoke are formaldehyde, acrolein, hydrocarbons, fatty acids, hydrocyanic acid, phenols, nitriles, acrylonitrile, hydrogen cyanide, benzene, and toluene. These particles can negatively affect the health of the operating room personnel. According to current guidelines, masks are recommended as the primary personal protective equipment to prevent respiratory exposure associated with surgical smoke. During surgical procedures, operating room staff frequently use surgical masks. Although surgical masks are the most commonly preferred personal protective equipment to protect healthcare workers against microorganisms and aerosols, they are unfortunately ineffective in filtering small particles. Therefore, the present study aimed to determine the impact of different types of masks on exposure to surgical smoke.

Detailed description

With the advancement of surgical techniques, the instruments and devices used in surgery have also rapidly evolved. Among these are energy-based devices that produce heat to achieve dissection or hemostasis during surgical procedures. Surgical smoke refers to the gaseous plume released into the air as a result of the thermal destruction of tissues by such devices, and is also termed cautery smoke, smoke plume, aerosol, or bioaerosol. While approximately 95% of surgical smoke consists of water vapor, the remaining 5% contains dead and viable cellular material, blood particles, viruses, bacteria, and toxic gases. The quantity and particle size of surgical smoke vary depending on factors such as the type of energy source, the tissue treated, and the duration and extent of treatment. Surgical smoke has been identified by professional associations as a chemical hazard affecting the safety of operating room environments. Larger particles (≥5 μm) deposit in the nasal and oropharyngeal regions, particles of 2-5 μm can reach the airways, and particles \<2 μm may penetrate lung tissue, accumulating in bronchioles and alveoli. Various toxic chemicals have been identified in surgical smoke, including formaldehyde, acrolein, hydrocarbons, fatty acids, hydrogen cyanide, phenols, nitriles, acrylonitrile, benzene, and toluene. Studies have also reported the presence of volatile organic compounds such as toluene, xylene, ethylbenzene, styrene, and naphthalene, with concentrations varying by procedure type. Exposure to surgical smoke negatively impacts the health of operating room staff, with reported symptoms such as headaches, nausea, throat irritation, cough, eye problems, respiratory difficulties, dermatitis, and anxiety. To mitigate these risks, recommended measures include staff education, awareness programs, installation of smoke evacuation systems, use of personal protective equipment, and development of institutional protocols. Among personal protective equipment, masks are the primary barrier recommended against respiratory exposure to surgical smoke. Although surgical masks are widely used to protect healthcare professionals against microorganisms and aerosols, they are largely ineffective in filtering fine particles. Professional guidelines advise the use of N95 respirators in conjunction with smoke evacuation systems, especially in procedures with high risk of viral transmission, given their superior filtration capacity. However, studies specifically examining the effectiveness of different types of masks against surgical smoke remain limited, with most research focusing on mask performance during the COVID-19 pandemic. Experimental studies comparing filtration efficiency have demonstrated superior performance of N95/FFP2 respirators compared to surgical masks. In this context, the present study aims to investigate the effectiveness of different mask types in protecting operating room staff from surgical smoke exposure.

Interventions

The collection of air samples will begin with the surgical incision and will continue for 10 minute

Sponsors

Mersin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

When the researchers (E.D., S.Ü., and S.GY.) enter the operating room, they will open the numbered envelope provided by the coordinating researcher (G.A.U.) to determine the group assignment of the surgery. All researchers other than the coordinating researcher will be blinded to the group allocations. The study data will be entered into a computer by another researcher (C.K.), who is not involved in the data collection process, in order to ensure blinding during data analysis and reporting.

Intervention model description

Prospective, parallel, three-arm, randomized controlled clinical trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Use of electrocautery, * Duration of surgery longer than 2 hours, * Elective total or partial hip prosthesis procedures.

Exclusion criteria

* No use of electrocautery, * Duration of surgery shorter than 2 hours, * Emergency total or partial hip prosthesis procedures.

Design outcomes

Primary

MeasureTime frameDescription
Change in airborne particle countThe number of particles in the air collected during the 10 minutes following the initiation of the surgical incision.Difference in particle count between masks

Countries

Turkey (Türkiye)

Contacts

Primary ContactSeher Gürdil Yılmaz, PhD.
gurdil@mersin.edu.tr+90 530 920 55 72

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026