Page 20 - OxyBand Research Background

OxyBand Dressing Accelerates Wound Healing

In addition to measuring changes in the size of the wounds, pain was assessed
by asking subjects to describe their level of pain on a graphic scale from 1 to 10. All

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subjects reported less pain from the OxyBand treated wounds without prior
knowledge of which wounds were test vs control dressings. Additionally, there was less
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pain reported upon removal of the OxyBand dressing compared to the Tegaderm
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dressing. It was observed that there was less ecchymosis and crusting on the wounds
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treated with OxyBand vs. the Tegaderm and that there was more edema observed
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on the Tegaderm treated wounds vs. the OxyBand treated wounds. No infections
or other complications were identified in either group.

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A second clinical study was conducted to test the efficacy of OxyBand
dressings in re-epithelialization of standardized laser burn wounds compared to an

identical placebo dressing (air filled). Table 2 presents the mean scores for
epithelialization (1% - 100%), exudate (1– 5 point scale), redness (1 – 5 point scale)

and pain (1 – 5 point scale) for all nineteen subjects who completed the study, including

follow up evaluations on days 3, 5, 6, 7, 8, 9, and 10. Nine of subjects did not complete
the study due to lack of compliance. Although the protocol for the study did not specify

as many days of wound evaluation, schedules and interest permitted more follow up
visits. Analysis of the data shows a significant difference between the wounds treated

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with OxyBand dressing and the wounds treated on the same subject with the placebo
dressing.

The primary endpoint for the second study was 100% epithelialization. By day
five, 5 out of 19 OxyBand treated wounds reached 100% epithelialization (Table 3
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and Photos 2A & 2B). By day 6 this number increased to 10 and by day 7, 19 out of 19

OxyBand treated wounds were 100% epithelialized. No placebo treated wounds
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reached 100% epithelialization until day 8 and all placebo treated wounds reached

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100% epithelialization on day 10. All OxyBand treated wounds were fully
epithelialized between day 5 and day 7 compared to placebo treated wounds that were

fully epithelialized between day 8 and day 10 (including the day of the laser procedure)
(Table 3). The mean time to 100% epithelialization for wounds was 6.2 Days + 0.9 for

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