Page 17 - OxyBand Research Background

OxyBand Dressing Accelerates Wound Healing

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control and were treated with the Tegaderm dressing. The burns on one arm of each
subject were treated with OxyBand while the burns on the opposite arm of each
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subject were treated with Tegaderm . Subjects were unaware of which dressing was
used on which set of wounds and dressings were randomly assigned to either arm for
each subject. Wounds were evaluated by board certified plastic surgeons blinded to

which was the control and which was the treatment wound. The dressings were
removed on day 3 and wounds were evaluated for lesion size, subjective pain

(evaluated utilizing a 10-point scale ranging from not painful to very painful). Fresh test

and control dressings were applied and a second evaluation of the wounds was
performed on day 7.

Oxyband v. Placebo Study. Twenty-eight healthy male and female volunteers

received standardized laser wounds in a similar pattern on the inner aspect of each
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upper arm. The burns measured 625 mm (1” by 1”) and were produced using an

Erbium laser (2940 nm wavelength) set to an ablation depth of 100 microns and a
thermal coagulation depth of 25 microns. Wounds were dressed by random assignment

with the treatment dressing, OxyBand (95% oxygen + 5% oxygen) or the control,
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placebo dressing (air filled, 21% oxygen). Each subject served as his or her own
control. In order to double-blind the experiment, dressings were randomly assigned red

or blue color-codes and the set of coded dressings were placed in individual plastic
bags and marked for each subject number.

Wounds were evaluated by two board-certified plastic surgeons experienced in
wound care, assisted by two trained nurse practitioners. Wounds were evaluated 3 days

after the laser procedure (day 1 being the day of the laser wound procedure) except for

subjects who had difficulty with keeping their dressings adhered. Under these
circumstances subjects were evaluated sooner. Whenever one dressing was replaced,

both dressings were replaced. Observers again evaluated subject wounds on day 6. A
few subjects were evaluated between day 3 and day 6 because the observer

determined on day 3 (visual examination) that that their wounds were likely to be 100%
epithelialized sooner than day 6. Subjects were asked to return more often subsequent

for evaluations of wounds until 100% epithelialization was observed.

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