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The efficacy of OxyBand Wound DressingTM has been evaluated in two civilian and one military clinical trial.

The first study was a, randomized, controlled, trial, conducted by a plastic surgeon, Stanley Poulos MD, (Aesthetic Plastic Surgery Center and Marin General Hospital, Greenbrae CA) which, compared the time to 100% wound healing, perceived pain at the wound site, redness and the degree of exudate of OxyBand Wound Dressing treated wounds compared to a standard polyurethane dressing, TegadermTM treated wounds, (standardized 50 micron laser burns) .

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The second study was a, randomized, controlled, double blind, trial, conducted by two plastic surgeons, Stanley Poulos MD and Cynthia Goodman, MD (Aesthetic Plastic Surgery Center and Marin General Hospital, Greenbrae CA) which, compared the time to 100% wound healing, perceived pain at the wound site, redness and the degree of exudate of OxyBand Wound Dressing, (95 + or – 5% O2) treated wounds, compared to placebo (identical, air filled dressing, 21% O2) on standardized 100 micron laser burn wounds.

The primary endpoint for both studies was 100% re epithelialization. The results from both studies showed OxyBand Wound Dressing™significantly healed wounds faster, (30 %) with less pain and exudate compared to standard care and placebo dressings. In both studies, patients served as their own controls. (14).

The third study was an independent, prospective, randomized, controlled, clinical trial, conducted by, the United States Army Institute for Surgical Research, (USAISR) which evaluated the efficacy of the OxyBand Wound Dressing™ on accelerating healing of donor site wounds compared to the standard of care at the USAISR Burn Center, Xeroform™. In the USAISR clinical trial, patients served as their own control and only patients requiring two donor sites were enrolled in the study. OxyBand and the control dressing, (XeroformTM) could be compared on healing identical wounds on the same patient. Therefore, differences in healing time between the treatments would be attributed to the dressing treatment, OxyBand Wound Dressing™ or Xeroform™.

The results from the USAISR study show, OxyBand Wound Dressing™, significantly accelerated healing (25%), and reduced pain at the wound site without any infections.

"Evaluation of an Oxygen Diffusion Dressing on Accelerating Healing of Donor Site Wounds" (ABSTRACT-K. F. Lairet, MD, FACS, L. C. Cancio, MD, FACS, M. L. Leas, RN, C. Galin, RN, E. M. Renz, MD, FACS, D. G. Baer, PhD, U.S. Army Institute of Surgical Research, Fort Sam Houston, TX).

Results from the clinical trial conducted by the, United States Army Institute of Surgical Research (USAISR), results was presented by Colonel Booker King MD of the USAISR at the 45th Annual American Burn Association Meeting in Palm Springs CA., on April 24, 2013.

The U.S. Army Institute of Surgical Research is a Center of Excellence for Battlefield Health, Trauma and Burn Research and Care.

CLICK HERE to read the Research Study Abstract

"The Efficacy of a Oxygen-Diffusing Dressing for Donor-Site Wound Healing" poster was presented at the Military Health Services Research Symposium by Dr. David Baer of the USAISR on August 14 2012.

CLICK HERE to see the Research Study Poster

OxyBand Wound Dressing™ cleared by the Food and Drug Administration FDA 510(k), K043063, provides oxygen to wounds for multiple days. Oxygen has been shown to promote wound healing (4-7). OxyBand Wound Dressing™, is a multi-layer wound dressing that comes pre-filled with high levels of oxygen between the layers. OxyBand Wound Dressing™ incorporates a barrier layer that holds the oxygen, in the vicinity, of the wound, and a permeable or porous layer that allows oxygen to diffuse into the wound. The dressing acts like an oxygen reservoir, allowing the wound to utilize as much oxygen as needed, and continues to supply oxygen on demand as the wound consumes oxygen from the wound fluid.

Oxygen Reservoir Dressing Sustains Elevated Wound pO2 After Hyperbaric Oxygen Treatment

Harriet Hopf, MD, University of Utah, Gerit Mulder, DPM and Jay Duchnick, CHT, University of California San Diego

The OxyBand™ reservoir dressing maintained elevated wound oxygen levels after HBOT, demonstrating that the dressing was able to replenish oxygen levels as it was consumed locally.

CLICK HERE to see the Research Study Poster

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