Strauch 2016.
| Methods | Simulation study, randomised controlled cross‐over trial How was the simulation performed? Two different simulations of contamination of the Filtering Facepiece Respirator (FFR) were performed: one in which the FFR was contaminated but not the hands and another one in which the hands were contaminated but not the FFR 1. Contamination of the FFR and clean hands: 20 subjects performed 3 trials of FFR with removal tabs (tab+) and tab‐ masks each in random order 2. Clean FFR and Contamination of hands: 20 subjects performed one tab+ trial and one tab‐ trial How was the exposure simulated? To contaminate the FFR, 7 mL of fluorescent tracer was brushed onto the entire outer surface of the test FFRs. As only the outer surface of the FFR was contaminated with the fluorescent tracer, transfer from the FFR to the hands would only occur if the FFR was doffed improperly by grasping the contaminated surface. 2. For the hand contamination test, 1 mL of fluorescent tracer was applied and rubbed into the hands of the test subject before removal of a clean FFR with or without tabs.The fluorescent tracer was prepared by suspending 1 g of GloGerm (GloGerm Company;Moab,UT) powder suspended in 25 mL of mineral oil. |
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| Participants | N = 20 aged 18‐60 HCW
Volunteers employed as HCW, that were enrolled in a respiratory protection program and experienced in wearing filtering face‐piece respirators (FFRs) were preferred, but a potential subject was not excluded if all of the qualities were not met. Volunteers were excluded if they had a history of skin cancer, sensitivity to Ultra Violet (UV) light, or burns from a black light Country: USA |
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| Interventions | Intervention: Mask with tabs; N‐95 mask with four red foam tabs attached to straps to assist in mask removal. Control: Mask with out tabs |
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| Outcomes | Contamination of the hands resulting from exposure to a contaminated mask. Contamination of the head resulting from exposure to contaminated hands: The subject’s head, face and hair were photographed under UVA light for contamination with fluorescent tracer. |
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| Notes | Location:USA; Funding source and conflict of interest were not published; reported on Lumens as a measure of contaminate but the written results did not match those presented in figure. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "each subject doffed one randomly assigned FFR" Unclear how randomisation was performed |
| Allocation concealment (selection bias) | Unclear risk | Unclear if allocation was irrevocable |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | not reported but unlikely to have influenced the outcome that was assessed by observers |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear if there were missing data |
| Selective reporting (reporting bias) | Unclear risk | no protocol available |
| Other bias | Low risk | No other biases detected |