Page 3 - OxyBand Research Background

Journal of Burn Care & Research
Volume 35, Number 3 Lairet et al 215

wounds were treated with 100% topical oxygen sup- the effectiveness of OxyBand and Xeroform dress-
plied continuously, and full-thickness punch biop- ings used as dressings for autogenous skin donor sites
sies were evaluated for epithelialization. The topical in burn patients. Informed consent was obtained
oxygen treatment group demonstrated significantly from each patient enrolled in the study. Subjects
greater healing response compared with controls, were adult burn patients with less than 30% TBSA
with a near doubling in the epithelial wound cover- thermal injuries admitted to the U.S. Army Institute
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age in the treatment group. Another animal study, of Surgical Research Burn Center, who required
using rats, examined the size of wounds over time surgical management of their wounds. Exclusion
treated with an oxygen-generating dressing versus criteria included significant comorbid medical con-
a control dressing. The rats treated with oxygen- ditions that could impair healing (such as diabetes or
generating dressing had a significantly shorter time peripheral vascular disease), patients diagnosed with
to closure of their wounds, compared with a similar burn wound cellulitis preoperatively, and critically
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occlusive dressing without oxygen. Hyperbaric oxy- ill patients on mechanical ventilation who would be
gen therapy is thought to improve healing of chronic unable to provide consent for the study or partici-
8
wounds in humans, but requires visits to facilities pate in the postoperative questionnaires.
with trained personnel and is limited by oxygen Patients were scheduled for excision and grafting
toxicity issues. Compared with hyperbaric oxygen of burn wounds, with a requirement of at least two
therapy, the benefits of topical oxygen would include donor sites. Epinephrine in lactated Ringer’s solu-
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lower cost, lack of systemic oxygen toxicity, and the tion at a concentration of 1:10 was injected subcu-
ability to receive treatment at home. 9,10 taneously to prepare both donor sites for harvesting
OxyBand is a U.S. Food and Drug Administra- for all patients but one. Donor sites were harvested
tion–approved (K043063) wound dressing for using a Zimmer dermatome set at 0.0010 inch
delivery of oxygen into the wound. This multilayer depth to ensure uniform thickness of the harvested
dressing comes prefilled with high levels of oxygen skin. Hemostasis was achieved by brief application
between the layers. The top layer is a barrier film of gauze sponges dipped in epinephrine in lactated
that holds the oxygen over the wound, whereas the Ringer’s solution at a concentration of 1:200,000.
bottom layer is a high–transfer-rate film, attached to The wounds were then treated with either the Oxy-
the wound. The barrier layer holds the oxygen in Band dressing (Figure 1) or Xeroform gauze. A
the vicinity of the wound, whereas the permeable or randomization table was used to determine which
porous layer allows the oxygen to diffuse into the donor site was treated with which dressing.
wound. The dressing acts like an oxygen reservoir. It Postoperatively, the donor wounds and dressings
is intended to allow the wound to use as much oxy- were inspected daily until postoperative day 4, then
gen as needed, and to supply oxygen on demand as every 2 days until both wounds were healed. The
the wound consumes oxygen from the wound fluid. OxyBand dressings were changed on postoperative
The dressing tends not to adhere to the donor site days 4 and 8, and then every 2 days until healed. In
itself, but rather is designed to adhere to its periph- addition, the OxyBand dressings were changed more
ery by means of an adhesive portion. frequently if the adhesive edges became nonadher-
Xeroform gauze (3% bismuth tribromophenate ent, or in the presence of an excessive amount of
and United States Pharmacopeia petrolatum on fine- exudate (as may occur in the immediate postopera-
mesh gauze) has been the preferred donor-site dress- tive period). Xeroform dressings were not changed.
ing used at this burn center for several years. In this Photographs were taken of the wounds at these time
clinical study, we compared the OxyBand dressing points, and the patients were asked to rate their pain
with the Xeroform dressing with respect to donor- (on a scale of 0–10) at each donor site on these vis-
site healing time. Secondary endpoints included pain its. Pain ratings were performed at rest, before per-
and cosmesis. formance of dressing changes. Patients whose donor
sites were not healed by the time of discharge from
MATERIALS AND METHODS the hospital were given instructions to return to the
burn clinic every 2 days for donor-wound assess-
This study was conducted under a protocol reviewed ments until both wounds were healed.
and approved by the Brooke Army Medical Center “Healed” was defined as the day on which, in the
Institutional Review Board, and in accordance with opinion of one of the staff burn surgeons, 90% or
the approved protocol. more of the wound surface was reepithelialized. The
We performed a single-center, prospective, ran- decision whether a wound was healed or not was
domized, controlled, open-label study to compare made purely on clinical appearance. Between days