Bacterial ContaminationNCT07900958
Bacterial Mask Contamination in Operating Room
A study testing Mask up or off and Mask dangling in people with Bacterial Contamination, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether surgical mask configuration policy-compliant (up or off ) versus mask dangling is associated with differences in bacterial contamination among unscrubbed operating room personnel at Atrium Health Wake Forest Baptist Hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Contamination
- What is being tested?
- Mask up or off and Mask dangling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Employment in perioperative services
- Routine use of surgical masks during clinical duties
- Ability and willingness to comply with the assigned mask configuration
Who cannot join
- Active respiratory infection or febrile illness at the time of participation.
- Active facial or neck skin infection that could influence bacterial culture results.
- Inability to safely wear a surgical mask.
- Inability or unwillingness to comply with the assigned mask configuration or other study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Samantha Staub contact
United States1 site
Atrium Health-Wake Forest Baptist
Winston-Salem, North Carolina, 27157
B. S Segal, MD, 336-716-4498, b.segal@wfusm.edu
Lynnette Harris, BSN, 336-306-0778, lynnette.harris@advocatehealth.org
About this study
Official title: Bacterial Contamination Associated With Surgical Mask Configuration in Unscrubbed Operating Room Personnel: A Randomized Microbiological Study
The primary objective of this study is to determine whether surgical mask configuration policy-compliant (up or off ) versus mask dangling is associated with differences in bacterial contamination among unscrubbed operating room personnel at Atrium Health Wake Forest Baptist Hospital.
Read the detailed description
Maintaining a sterile operating room (OR) environment is a priority because it prevents surgical site infection (SSIs) and provides optimal patient outcomes. Due to this, infection prevention policies are implemented in perioperative practices and are designed to minimize the risk of microbial contamination during surgical procedures. There is a policy that requires unscrubbed OR personnel to have their mask either "up" in restricted areas or completely removing it "off" when moving to non-restricted areas. This "up or off" policy prohibits personnel from allowing their masks to hang around their neck a practice that was once done called "dangling".
This study will address this evidence gap by comparing bacterial contamination associated with policy-compliant surgical mask configuration ("up or off") and mask dangling among unscrubbed OR personnel at Atrium Health Wake Forest Baptist Hospital. Bacterial contamination will be assessed using colony-forming unit (CFU) counts from specified sampling sites before and after a standardized observation period.
- Conditions
- Bacterial Contamination
- Being tested
- Mask up or off, Mask dangling
- Keywords
- bacterial contamination, mask placement, skin and respiratory microbiomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mask up or offOther
mask if either being worn or off
Mask danglingOther
mask dangling around neck when not being worn
| Study group | Role | What they receive |
|---|---|---|
| Mask on or off | Active comparator | mask either up or off Receives: Other: Mask up or off |
| Mask dangling | Experimental | mask dangling around neck Receives: Other: Mask dangling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Bacterial contamination between mask up/off or dangling
Bacterial contamination is measured as quantitative bacterial burden, measured as colony-forming units (CFUs), recovered from cultures collected from the inner and outer surfaces of surgical masks before and after the standardized 2-hour observation period.
Measured: Hour 2
Secondary outcomes (3)
CFU counts recovered from additional sampling sites
CFU counts recovered from additional sampling sites, including the neck skin, dominant hand, and anterior chest region of the scrub top
Measured: Hour 2
Changes in CFU counts between baseline and post-observation
Changes in CFU counts between baseline and post-observation at each sampling site.
Measured: Hour 2
Differences in bacterial loads at different culture sites
Patterns of bacterial distribution across sampling locations that may provide insight into potential contamination pathways - differences in bacterial loads and or species at different culture sites - Variations in the counts may provide insights into mechanisms of possible contamination based on mask wearing practice style
Measured: Hour 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ContaminationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- B. S Segal, MD, Principal investigator, Advocate Health-Wake Forest School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900958
- Sponsor's protocol ID
- IRB00156869
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Contamination Associated With Surgical Mask Configuration in Unscrubbed Operating Room Personnel: A Randomized Microbiological Study
- ClinicalTrials.gov ID
- NCT07900958
- Acronym / sponsor ID
- IRB00156869
- Conditions
- Bacterial Contamination
- Keywords
- bacterial contamination, mask placement, skin and respiratory microbiomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Oct 2026 (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.
The primary objective of this study is to determine whether surgical mask configuration policy-compliant (up or off ) versus mask dangling is associated with differences in bacterial contamination among unscrubbed operating room personnel at Atrium Health Wake Forest Baptist Hospital.
Detailed description
Maintaining a sterile operating room (OR) environment is a priority because it prevents surgical site infection (SSIs) and provides optimal patient outcomes. Due to this, infection prevention policies are implemented in perioperative practices and are designed to minimize the risk of microbial contamination during surgical procedures. There is a policy that requires unscrubbed OR personnel to have their mask either "up" in restricted areas or completely removing it "off" when moving to non-restricted areas. This "up or off" policy prohibits personnel from allowing their masks to hang around their neck a practice that was once done called "dangling".
This study will address this evidence gap by comparing bacterial contamination associated with policy-compliant surgical mask configuration ("up or off") and mask dangling among unscrubbed OR personnel at Atrium Health Wake Forest Baptist Hospital. Bacterial contamination will be assessed using colony-forming unit (CFU) counts from specified sampling sites before and after a standardized observation period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mask on or off | Active comparator | Other: Mask up or offmask either up or off |
| Mask dangling | Experimental | Other: Mask danglingmask dangling around neck |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Employment in perioperative services
- Routine use of surgical masks during clinical duties
- Ability and willingness to comply with the assigned mask configuration
Key exclusion criteria (4 listed)
- Active respiratory infection or febrile illness at the time of participation.
- Active facial or neck skin infection that could influence bacterial culture results.
- Inability to safely wear a surgical mask.
- Inability or unwillingness to comply with the assigned mask configuration or other study 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 |
|---|---|---|
| Mask up or offmask if either being worn or off | Other | Mask on or off |
| Mask danglingmask dangling around neck when not being worn | Other | Mask dangling |
Primary outcome
Amount of Bacterial contamination between mask up/off or dangling
Time frame: Hour 2
Bacterial contamination is measured as quantitative bacterial burden, measured as colony-forming units (CFUs), recovered from cultures collected from the inner and outer surfaces of surgical masks before and after the standardized 2-hour observation period.
3 secondary outcomes
CFU counts recovered from additional sampling sites
Time frame: Hour 2
Changes in CFU counts between baseline and post-observation
Time frame: Hour 2
Differences in bacterial loads at different culture sites
Time frame: Hour 2
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Samantha Staub contact
B. S Segal, MD principal investigator
Advocate Health-Wake Forest School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask up or off and Mask dangling in people with Bacterial Contamination, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 inclusion and 4 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 28 Oct 2026. 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 United States. 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 B. S Segal, MD (336-716-4498, b.segal@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Bacterial contamination between mask up/off or dangling (time frame: Hour 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.