Tomas 2016.
Methods | Simulation study, randomised control trial; parallel groups How was the simulation performed? Participants removed improved gowns and gloves in their usual manner. How was the exposure simulated? Gloved hands were inoculated with 0.5 mL phosphate‐buffered saline (PBS) containing 10^10 plaque‐forming units of MS2 and 0.5 mL fluorescent lotion and the solutions were rubbed over the gloved hands until dry. Bacteriophage MS2 was of the type 15597‐B1 (American Type Culture Collection,VA). |
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Participants | N = 30 Healthcare personnel; No other information provided; asked authors for more information. | |
Interventions |
Intervention: A seamless PPE prototype in which adhesive material on the outer sleeve of the gown at the wrist attaches to the inner cuff of the gloves, providing continuous coverage of the wrist and hand. This design prevents exposure of skin and requires that gloves be peeled off as the gown is removed. The prototype seamless PPE consisted of polyethylene contact isolation gowns (SafetyPlus Polyethylene Gown, TIDI Products, Neenah, WI) and nitrile gloves (Denville Scientific, South Plainfield, NJ).Permanent contact bond adhesive (DAP Weldwood Contact Cement, DAP Products, Baltimore, MD) was applied circumferentially to the outer gown at the level of the wrist.Gloves were pressed to the gowns for 15 minutes and allowed to air dry for 24 hours. Control: Only described as standard PPE and assumed as gloves and gown |
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Outcomes | 1. Outcome assessment fluorescent: Hand and wrist skin contamination with the fluorescent lotion was assessed using a black light (Ultra Light UV1 by Grizzly Gear, SCS Direct,Trumball, CT). 2. Outcome assessment Bacteriophage: Participants then wiped both hands and wrists with a sterile, pre‐moistened 4 × 4 gauze pad that was placed into a sterile container containing 10 mL PBS and mixed in a vortex mixer for 1 minute to elute the bacteriophage. Aliquots of each elutant were serially diluted and cultured to quantify virus particles. |
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Notes | Location: USA; Funding was provided by the Department of Veteran Affairs; One author, C.J.D. had previously received research grants from Clorox, Merck, AvidBiotics and GOJO and the same author also served on scientific advisory boards for 3M and Seres Health. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Healthcare personnel were randomized to perform simulations of contaminated glove removal"; authors asked for method of generation |
Allocation concealment (selection bias) | Unclear risk | unclear if irrevocable |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not blinded but objectively measured outcome |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on missing data provided |
Selective reporting (reporting bias) | Unclear risk | No protocol published |
Other bias | Low risk | No other biases detected |