Page 30 - OxyBand Research Background

The Efficacy of an Oxygen Reservoir Dressing, OxyBand TM on Accelerating Wound Healing
A Randomized Controlled Double Blind Clinical Trial
Stanley Poulos, MD 1,2 , Cynthia Goodman, MD 1, ,
THE HEALING POWER OF O 2
1 Aesthetic Plastic Surgery Center, 1240 South Eliseo Drive, Suite 201, Greenbrae, CA 94904 2 Plastic Surgery Specialists, 350 Bon Air Road, Greenbrae, CA 94904
Abstract Results and Discussion
The efficacy of an oxygen (O 2 ) reservoir wound dressing, OxyBand TM , on accelerating wound
healing was compared to a placebo air filled dressing in a randomized controlled double blind Photograph 1: Photograph 2:
trial (RCDT). Healing, 100% Epithelialization, pain, redness and inflammation were measured Epithelialization of Wounds; OxyBand TM Vs. Placebo Wound Exudate Levels; OxyBand Vs. Pl
on standardized burn wounds of healthy volunteer subjects. A previous study comparing the
efficacy of OxyBand TM to a standard dressing, Tegaderm TM . OxyBand treated wounds had a
significantly greater reduction in mean wound diameter by 40% on day three (including the day
of the laser procedure) 40% and on day seven by 3.49 mm + 0.27 at p < .001 on day 7
compared to the Tegaderm TM treated wounds with a reduction 5.00 to 2.65 mm in diameter.
The present clinical study was an RCDT trial that compared OxyBand TM dressing (95 + 5% O 2 )
to a placebo (identical dressing) an air filled (21% O 2 ) on standardized on 38, 1” by 1” wounds
of subjects who served as their own control. OxyBand treated wounds healed significantly
faster than placebo treated wounds with less pain redness and Exudate. The mean time to
healing for all OxyBand treated wounds was 6.2 days + 0.9 compared to placebo treated
wounds with a mean healing time of 8.8 days + 0.7. Accelerating healing is critical in healing
burns, combat wounds and other wounds. OxyBand treated wounds were also perceived to be
less pain. Photo 1A: OxyBand TM Treated Photo 1B: Placebo Treated Photo 2A: OxyBand TM Treated Photo 1B: Placebo Treated
Introduction Photograph 1, A & B, shows wounds on both arms of a subject on day 4, day 1 counted as the day of surgery, as example, the wound randomly assigned
OxyBand TM is 95% epithelialized and the placebo treated wound is not epithelialized to the same extent. Photograph 2, A & B, show the OxyBand treated
Research in oxygen and wound healing has shown that oxygen is essential for wound of another subject with significantly less exudate than placebo treated wound on day 2. The visual Tab
tissue repair including angiogenesis, collagen synthesis, epithelialization, wound (1% - 100%), exudate (1 – 5 point scale), redness (1 – 5 point scale) and pain (1 – 5 point scale) fo
contraction, and to prevent infections. Research in animals and in humans has reported significantly less pain with OxyBand TM treated wounds and had significantly less redness and ex
demonstrated that the basic physiology of wound healing is oxygen dependent, and endpoint for the study was 100% epithelialization. By day five, 5 out of 19 OxyBand treated wounds reac
several aspects of the healing process are accelerated with higher oxygen levels. number increased to 10 and by day 7, all of the OxyBand treated wounds were 100% epithelialized. No pl
For example, collagen synthesis is enhanced under hyperoxic conditions. day 7. Placebo treated wounds reached 100% epithelialization on day 10. A significant difference was found betw
Angiogenesis, on the other hand, appears to be stimulated by both a hypoxic tissue 001 OxyBand TM wounds were 100% epithelialized in a 6.2 days + 0.9 compared to placebo treated wound
gradient, with new capillaries extending in the direction of lower oxygen 0.7. These results support the results from the previous study comparing the efficacy of OxyBand TM wound dre
concentration, and by hyperoxic conditions. showed OxyBand TM treated wounds healed significantly faster than standard of care Tegaderm TM treated wounds, day 3, OxyBand TM wounds
Oxygen treatment in the form of hyperbaric oxygen (HBOT) has become a standard epithelialized compared to Tegaderm TM treated wounds which were 25% epithelialized, by day 7,
treatment for non healing wounds. Topical oxygen treatment has not become OxyBand TM treated wounds were 91% epithelialized compared to Tegaderm TM treated wounds Conclusions
standard because until the clinical studies described in this poster there were not which were only 72% epithelialized.
reported results from randomized controlled double blind trials on topical oxygen. The poster presents the results from an RCDB study
Topical oxygen if effective in wound healing, would be more cost effective, evaluating the efficacy of OxyBand TM (O 2 ) dressing to
accessible, and not pose the same risks that are associated with HBOT. The RCDT Table 1: Mean Epithelialization, Exudate, Redness and Pain for OxyBand TM vs. Placebo accelerate heal
described compared the efficacy of OxyBand TM to Placebo in accelerating wound Day 3 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 wounds compared to an identical placebo (air fi
healing, reducing pain, redness and exudate. A previous study demonstrated that Treatment Oxy- Placebo Oxy- Placebo Oxy- Placebo Oxy- Placebo Oxy- Placebo Oxy- Placeb
OxyBand TM accelerated wound healing compared to Tegaderm TM . Band Band Band Band Band Band Band accelerated wound healing as measured by 100%
Methods (N) Number of Wounds 19 19 19 19 19 19 19 19 19 19 19 19 19 19 epithelialization compared to placebo, with a correlative
decrease in pain, redness and exudate. The efficacy of
Nineteen male and female healthy volunteers received standardized 100 micron and Mean Epithelialization 13% 0% 31% 14% 92% 63% 100% 67% 100% 87% 100% 94% 100%
25 micron thermal coagulation, 1” by 1” laser burns on the upper aspect of the left Mean Exudate Score 1.21 2.42 0.50 1.50 0.32 1.21 0.00 0.05 0.00 0.00 0.00 0.
and the right arm. Subjects served as their own control. Wounds on the right or left Mean Redness Score 1.89 3.05 1.67 2.83 0.84 2.37 0.23 0.95 0.11 0.53 0.00 0
arm of each subject was dressed by random assignment with either the OxyBand TM healing, as measured by the reduction in size of the burn
dressing (95% oxygen + 5% oxygen) or the placebo dressing (air filled, 21% Mean Pain Score 0.84 2.32 0.50 1.33 0.32 0.83 0.00 0.07 0.00 0.05 0.00 0.00 0.00
oxygen). OxyBand TM compared to wounds treated with
Wounds were evaluated by two board-certified plastic surgeons experienced in Table 2: Cumulative Subjects Fully Epithelialized Tegaderm TM . Together these results strongly suggest t
wound care, assisted by two trained nurse practitioners on day 3, 5, 6, 7, 8, 9 & 10. Oxy/P Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 OxyBand TM significantl
Wounds were also evaluated for redness and exudate on a scale of 1-5. Subjects partial thickness wounds compared to both standard of
were asked to assess their own pain on a scale of 1-5 and wounds. Percent OxyBand 0 0 5 10 19 19 19 19 care and placebo. The potential benefits to combat
epithelialization by two plastic surgeons (0% to 100%) and photographed. After Placebo 0 0 0 0 0 7 16 19 casualty care for treating burns and other wounds is
evaluation of scar appearance at 30 days, the study was unblinded. significant. Further studies are warranted.
* References upon request.