Surgical SmokeNCT07161609
The Effect of Masks on Surgical Smoke Exposure
A study testing Particle counter in people with Surgical Smoke, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Smoke
- What is being tested?
- Particle counter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Use of electrocautery,
- Duration of surgery longer than 2 hours,
- Elective total or partial hip prosthesis procedures.
Who cannot join
- No use of electrocautery,
- Duration of surgery shorter than 2 hours,
- Emergency total or partial hip prosthesis procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mersin University
Mersin, 33010
Seher Gürdil Yılmaz, PhD., +90 530 920 55 72, gurdil@mersin.edu.tr
About this study
Official title: The Effect of Different Types of Masks on Surgical Smoke Exposure
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.
Read the 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.
- Conditions
- Surgical Smoke
- Being tested
- Particle counter
- Keywords
- Surgical smoke, Particle, Mask, Operating room team
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Particle counterDevice
The collection of air samples will begin with the surgical incision and will continue for 10 minute
| Study group | Role | What they receive |
|---|---|---|
| Single surgical mask | Experimental | During the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a single surgical mask to the tip of the particle counter. Receives: Device: Particle counter |
| Double surgical mask | Experimental | During the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a double surgical mask to the tip of the particle counter. Receives: Device: Particle counter |
| N95 mask | Experimental | During the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a N95 surgical mask to the tip of the particle counter. Receives: Device: Particle counter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in airborne particle count
Difference in particle count between masks
Measured: The number of particles in the air collected during the 10 minutes following the initiation of the surgical incision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical SmokeStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, three-arm, randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Gürdil Yılmaz, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161609
- Sponsor's protocol ID
- Different Types of Masks
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to avoid duplication, it is not intended to be shared until the research is completed.
Publications
Dikmen Aydın, Y., Gürkan, A., & Kırtıl, İ. (2024). Cerrahi duman: Ameliyathanede çalışan sağlık profesyonellerine etkisi ve alınan önlemlerin incelenmesi. Sağlık ve Yaşam Bilimleri Dergisi, 6(1), 40-47.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Masks on Surgical Smoke Exposure
- ClinicalTrials.gov ID
- NCT07161609
- Acronym / sponsor ID
- Different Types of Masks
- Conditions
- Surgical Smoke
- Keywords
- Surgical smoke, Particle, Mask, Operating room team
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, parallel, three-arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Single surgical mask | Experimental | Device: Particle counterDuring the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a single surgical mask to the tip of the particle counter. |
| Double surgical mask | Experimental | Device: Particle counterDuring the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a double surgical mask to the tip of the particle counter. |
| N95 mask | Experimental | Device: Particle counterDuring the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a N95 surgical mask to the tip of the particle counter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Use of electrocautery,
- Duration of surgery longer than 2 hours,
- Elective total or partial hip prosthesis procedures.
Key exclusion criteria (3 listed)
- No use of electrocautery,
- Duration of surgery shorter than 2 hours,
- Emergency total or partial hip prosthesis procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Particle counterThe collection of air samples will begin with the surgical incision and will continue for 10 minute | Device | Double surgical mask, N95 mask, Single surgical mask |
Primary outcome
Change in airborne particle count
Time frame: The number of particles in the air collected during the 10 minutes following the initiation of the surgical incision.
Difference in particle count between masks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publicationDikmen Aydın, Y., Gürkan, A., & Kırtıl, İ. (2024). Cerrahi duman: Ameliyathanede çalışan sağlık profesyonellerine etkisi ve alınan önlemlerin incelenmesi. Sağlık ve Yaşam Bilimleri Dergisi, 6(1), 40-47.
- Individual participant dataSharing planned: No. In order to avoid duplication, it is not intended to be shared until the research is completed.
Related trials for Surgical Smoke
Not yet recruitingObservational study
Preoperative Smoke Check and Surgical Smoke Evacuation Compliance
Surgical Smoke Exposure
Not yet recruiting
Effectiveness of Brief Smoking Cessation Counselling in Pre-Anaesthesia Assessment Clinic
Smoking ( Cigarette)
Recruiting
THE EFFECT OF SURGICAL MASK AND N95 MASK USE ON SURGICAL SMOKE IN OPERATING ROOM NURSES
Surgical Smoke Exposure, Occupational Exposure to Surgical Smoke
RecruitingObservational study
AI-Based Real-Time Detection of Surgical Smoke Using Endoscopic Data
Detection of Surgical Smoke Gas Using AI
Recruiting
Effects of Multi-strategy Evidence-based Education Training Programs on Knowledge, Attitude, and Preventive Behavior Towards Surgical Smoke Hazards Among Operating Room Nurses
Electrocautery Smoke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Particle counter in people with Surgical Smoke, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seher Gürdil Yılmaz, PhD. (+90 530 920 55 72, gurdil@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in airborne particle count (time frame: The number of particles in the air collected during the 10 minutes following the initiation of the surgical incision.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07161609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.