Purifas® FaceShield™ Independent Clinical Trial

In November 2021, Purifas sponsored a clinical trial that was developed and completed by an independent microbiologist from Macquarie University in Sydney. This trial tested the effectiveness of our FaceShield in reducing the transmission of both bacteria and saliva, which in turn reduces consumers’ exposure to harmful pathogens and the risk of illness.

Details of the trial are as follows:

• Seven subjects were given two 10-minute massages while lying face down on a therapy bed.
• For the first massage, the face hole of the therapy bed was covered with our FaceShield.
• For the second massage, the face hole was left exposed.
• During each massage, the subject was asked to cough twice, as well as count to 60 out loud to mimic a conversation.
• Before each massage, the therapy bed was wiped down using a 99.9% antibacterial agent; contact plates were gently pressed on to the resting place of the forehead and chin to acquire surface samples for bacteria testing; the internal aspect of the face hole was swabbed with a sponge swab dipped in neutralising solution; and RSID-saliva kits were used to test for the presence of saliva.
• The bacteria and saliva test methods were also taken immediately after each massage.

The collected data was then forwarded to a statistician and the following results were deduced:

• The FaceShield reduces the number of bacteria by an average of 84%.
• There is no evidence to show that the antibacterial wipes used are more effective than using the FaceShield.
• For all seven subjects, saliva was present on the internal aspect of the face hole where the FaceShield was not used — and was classed as either “positive” or “strong positive” by the independent microbiologist.
• Comparatively, when the FaceShield was used the saliva that was present was equivalent to baseline figures (after cleaning) on all seven subjects, indicating no additional saliva was transmitted with the use of the FaceShield.

A bacteria colony-forming unit (CFU) is a measure of the number of live cells that are able to multiply. It was shown that during a 10-minute massage (with no FaceShield) an astonishing 55,643 CFUs would be present, on average, on the internal aspect of the face hole. This is the minimum number of CFUs the next client’s face would be exposed to if the therapist was not compliant with hygiene practice. (It is worth noting that the number of CFUs would increase as the number of clients who used the same bed increased.) This number was reduced to less than 1,815 when the FaceShield was used.

For our research and statistically inclined customers

Although a statistical difference (p-value < 0.05) was shown in the data collected from this clinical trial, the null hypothesis suggests there may be no significant difference between specified populations and that any observed difference could potentially be due to sampling size or experimental error. To overcome this, a power test, which is the probability of rejecting the null hypothesis when in fact it is false, was performed and showed that in order to have 95% power, thereby increasing the reliability of this data, there should be 30 participants in each group.

For this reason, Purifas is currently working with Macquarie University directly to recreate this study with a larger subject group to ensure its accuracy and assist in changing standard practice.