Purifas® BodyShield™ Independent Clinical Trial

To further ensure our BodyShield effectively fulfilled our hygiene requirements in a therapeutic setting, 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 BodyShield in reducing bacterial transmission and, in turn, diminishing 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 therapy bed was covered with our BodyShield.
• For the second massage, the therapy bed was left exposed.
• For each massage the subject’s arms were positioned over the edge of the bed to ensure the armpits were exposed to the therapy bed (which for some is a very natural position).
• Before each massage, the therapy bed was wiped down using a 99.9% antibacterial agent. Sponge swabs of the anticipated armpit resting place were taken to determine the baseline of bacteria present.
• Sponge swabs of both the left and right armpit areas were also taken immediately after each massage.

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

• 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 the left (L) and right (R) armpits would transfer, on average, 143 and 122 bacteria CFUs respectively.
• This is the minimum number of CFUs the next client 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.)
• When using the BodyShield, bacteria from the left and right armpits is reduced by 98% and 91% respectively. Combining the data from both armpits (and in turn strengthening the accuracy of information), bacteria is reduced by 94%.

Control Swab (pre-massage)	With BodyShield	Without BodyShield

For our research and statistically inclined customers only

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.