Turner 2004b.
Study characteristics | ||
Methods | Double‐blind RCT conducted by Hill Top Research, Inc., Winnipeg, Canada, to assess the residual virucidal activity of a skin cleanser wipe and its effectiveness in preventing experimental rhinovirus colds. Participants in good health, aged 18 to 60 years, were recruited from Winnipeg and surrounding communities for participation. The residual activity of a skin cleanser wipe containing 4% pyroglutamic acid formulated with 0.1% benzalkonium chloride was tested. The negative control treatment was 62% ethanol. Benzalkonium chloride had been previously tested and was found to have no virucidal activity. Volunteers were randomly assigned to use the control preparation or the active preparation. The study material was applied to hands with a towelette. 15 minutes later, when the fingers were completely dry, the fingertips of each hand of the control participants and the volunteers in the active treatment group were contaminated with rhinovirus type 39. An additional volunteer in the active group was challenged with virus 1 hour after application, and the final group of volunteers was challenged 3 hours after application. Viral infection was assessed by culture of nasal lavage specimens and blood samples. | |
Participants | 122 volunteers; 30 in control group, 92 in active group (30 tested after 15 minutes, 30 after 1 hour, 32 after 2 hours) | |
Interventions | Use of a skin cleanser wipe containing 4% pyroglutamic acid formulated with 0.1% benzalkonium chloride versus skin cleanser wipe containing ethanol | |
Outcomes | Laboratory: yes Effectiveness: rhinovirus type 39 infection Safety: N/A | |
Notes | Risk of bias: unclear (no description of randomisation process, concealment or allocation) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised" Sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "double blind", but no description given |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "double blind", but no description given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All accounted for (short study). |
Selective reporting (reporting bias) | High risk | Poorly reported |