Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds

Patients who are scheduled for excision of burns or other injuries will have one of two
donor sites covered with the OxyBand Dressing, and the other treated according to standard
of care. OxyBand is an FDA (Food and Drug Administration) approved (K043063) wound dressing
for delivery of oxygen into the wound. Two small clinical studies using OxyBand have been
conducted on standardized laser burn wounds, demonstrating faster healing time compared to a
placebo. No studies have compared this dressing to Xeroform dressing, the standard dressing
used on donor sites in the USAISR.

Inclusion Criteria:

- Subject must be at least 18 years of age; of either gender and in good general
health.

- Subject has sustained burn wounds of less than 30 percent of the total body surface
area

- Burn wounds do not involve the harvesting area

- Subject has sustained burn wounds that, in the judgment of the attending surgeon,
require excision and grafting of sufficient extent to justify two donor sites of
equal and symmetrical size on non-dependent body surfaces areas

- The scheduled excision and grafting procedure is the first such operation for the
subject during this hospitalization

- Subject agrees to participate in follow-up evaluations

Exclusion Criteria:

- Critical illnesses such as those requiring ventilator support, or having a systemic
infection or hemodynamic instability, defined as a mean arterial pressure less than
60 or requiring vasoactive medications to support blood pressure

- Major acute or chronic medical illnesses that could affect wound healing (e.g.
peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)

- Subjects receiving treatment with medications that inhibit or compromise wound
healing. Examples include therapeutic anticoagulants, antiplatelet drugs, and
systemic steroids such as warfarin, clopidogrel or prednisone. The use of
anticoagulants does not include DVT (Deep Vein Thrombosis) prophylaxis. Subjects may
use aspirin or lovenox

- Cellulitis or other infection of the potential donor sites

- Donor site has been previously harvested for grafting

- Subjects with greater than 30% total body surface area burns

- Pregnancy

- Prisoners