Page 4 - OxyBand Research Background

Journal of Burn Care & Research
216 Lairet et al May/June 2014

in healing time with a confidence level of 95%. Data
were analyzed using the Statistical Analytical Soft-
ware. Continuous and score variables were compared
via Wilcoxon test for nonparametric data. All tests for
significance were two-tailed with α = .05.

RESULTS

A total of 20 patients were enrolled, of whom 17
completed the study. Of the three who did not com-
plete the study, one enrolled patient required only
one donor wound in the operating room. Another
patient was enrolled but was not studied because
surgery was deemed unnecessary on repeat examina-
Figure 1. Typical appearance of OxyBand dressing on a tion. A third patient did not return for study visits
donor site. and was lost to follow-up. Eight military and 12 civil-
ian patients were enrolled, with three women and 17
30 to 45 after surgery, the patient’s donor sites were men. Mean age was 35.0 (range, 20–49) years. Mean
evaluated for cosmesis. Digital photos were evalu- burn size was 9.2% TBSA (range, 2–24%).
ated later by a burn surgeon blinded to the dressings OxyBand donor sites healed in an average of
and not associated with the study, according to the 9.4 ± 1.7 days (range, 6–12 days). Xeroform sites
scar-assessment scale developed by Yeong et al. 11 healed in an average of 12.4 ± 2.7 days (range, 8–20
The design of the OxyBand dressing incorporates days) (P < .01). There were no wound infections in
a circular pattern on the surface of the dressing, either group. Two patients were found to have blisters
which interfaces with the wound. When considering at their donor sites at their final 30- to 45-day visit;
the dressing for a clinical trial on human donor-site the blisters were present at both OxyBand and Xero-
wounds, concern was raised about the potential for form sites. No other unanticipated events occurred.
wounds to heal with this circular pattern, as it would Study patients were asked to rate their pain on a
leave the patient with an inconsistent scar or a pseudo- scale of no pain (0) to maximum pain (10) at each
tattoo. To further investigate this concern, a separate donor site at set points in the study. These assess-
animal study was conducted before enrollment of ments were made at rest, before the performance
patients in the clinical trial described in this article. of dressing inspections or changes. On postopera-
The study animal received six wounds, identical to tive day 4, pain at the OxyBand site averaged 0.6,
human donor-site wounds in depth and size, five of whereas Xeroform sites were rated an average of 1.6
which were dressed with OxyBand, and one with (P < .05). Pain diminished by postoperative day 8,
Xeroform. At 2 weeks after operation, a faint circular but was still significantly less at the OxyBand site
pattern was observed in two of the OxyBand wounds. (0.4) than at the Xeroform site (1.4; P < .05). By
This pattern disappeared and, at 30 days, all wounds postoperative days 10 and 12, few patients reported
were evenly healed with no discernible pattern. any pain. There continued to be a statistically signifi-
Because there was a temporary pattern observed cant difference between the two groups, however. At
in some of the study pigs’ wounds during the healing postoperative 10, the average pain rated at OxyBand
process, the human clinical study paused for a safety sites was 0.3 compared with 0.8 at the Xeroform site
analysis after the first six patients were enrolled. The (P < .05). On postoperative 12, pain score of Oxy-
first six patients were followed up for 30 to 45 days Band wound averaged 0.2, with Xeroform wound
postoperatively, and their wound photographs were receiving an average 0.5 rating (P < .05).
interpreted by a burn surgeon not affiliated to the At the conclusion of the study, photographs of
study. The results were discussed by a panel before the patients’ donor wounds (from days 30–45)
proceeding with study. As there was no significant were analyzed by two surgeons not associated with
difference noted in the 30- to 45-day cosmetic out- the study. Of the 17 patients, there were 13 sets of
come of the OxyBand versus the control wounds, photos for final evaluation of cosmetic outcome.
the study continued to completion. Three patients’ photos were inaccessible because
A power analysis conducted by our statistician con- of technical difficulties. Of the 13 evaluable sets of
cluded that 17 patients, providing 34 matched donor photos, four patients’ wounds (OxyBand vs Xero-
sites, would be required to demonstrate a difference form) were without significant difference in cosmetic