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

Completed · Not applicable

Conditions studied: Burns

In brief

This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean healing time for wounds treated with the OxyBand dressing will be less than the mean healing time for wounds treated with the Xeroform dressing.

Key facts

Study ID

NCT01268189

Run by

United States Army Institute of Surgical Research

People needed

20

Starts

2010-08-01

Expected to finish

2012-03-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• US Army Institute of Surgical Research, Burn Center — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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