D. Voigt

Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment.

The safety and effectiveness of Integra Dermal Regeneration Template was evaluated in a postapproval study involving 216 burn injury patients who were treated at 13 burn care facilities in the United States. The mean total body surface area burned was 36.5% (range, 1-95%). Integra was applied to fresh, clean, surgically excised burn wounds. Within 2 to 3 weeks, the dermal layer regenerated, and a thin epidermal autograft was placed. The incidence of invasive infection at Integra-treated sites was 3.1% (95% confidence interval, 2.0-4.5%) and that of superficial infection 13.2% (95% confidence interval, 11.0-15.7%). Mean take rate of Integra was 76.2%; the median take rate was 95%. The mean take rate of epidermal autograft was 87.7%; the median take rate was 98%. This postapproval study further supports the conclusion that Integra is a safe and effective treatment modality in the hands of properly trained clinicians under conditions of routine clinical use at burn centers.

Effects of oxandrolone on outcome measures in the severely burned: a multicenter prospective randomized double-blind trial.

Severe burns induce pathophysiologic problems, among them catabolism of lean mass, leading to protracted hospitalization and prolonged recovery. Oxandrolone is an anabolic agent shown to decrease lean mass catabolism and improve wound healing in the severely burned patients. We enrolled 81 adult subjects with burns 20% to 60% TBSA in a multicenter trial testing the effects of oxandrolone on length of hospital stay. Subjects were randomized between oxandrolone 10 mg every 12 hours or placebo. The study was stopped halfway through projected enrollment because of a significant difference between groups found on planned interim analysis. We found that length of stay was shorter in the oxandrolone group (31.6 ± 3.1 days) than placebo (43.3 ± 5.3 days; P < .05). This difference strengthened when deaths were excluded and hospital stay was indexed to burn size (1.24 ± 0.15 days/% TBSA burned vs 0.87 ± 0.05 days/% TBSA burned, P < .05). We conclude that treatment using oxandrolone should be considered for use in the severely burned while hepatic transaminases are monitored.

Using skin replacement products to treat burns and wounds.

Much progress has been made toward the development of artificial skin replacement products. Continued research promises to bring more products to the marketplace, and each new product seems to develop a niche in the field of skin replacement. However, although each skin replacement product has unique properties and advantages, nothing works as well as a patients own skin. Clinicians can only hope for an off-the-shelf skin replacement product that can be applied to a wound and yield a permanent, dependable dermis and epidermal skin replacement for all patients.

A retrospective study on the effectiveness of intranasal midazolam in pediatric burn patients

Pain control is a major issue concerning children admitted for burns. Pain and anxiety associated with twice daily wound cleansing and dressing changes are difficult to control, especially if there is no intravenous access. We explored the effectiveness of intranasal midazolam (INM) combined with intravenous and/or oral pain medications prior to painful treatments. Charts of all patients admitted from October 1995 to November 1996 under the age of 9 were reviewed for use of INM. Twelve patients had INM used at some point during their hospitalization. Our study covers this group, with each child acting as his/her own control. Pain and response to medication during wound cleansing was assessed by the nursing staff as documented in the patients nursing assessment. Nursing documentation indicated that patient response was positive regarding the use of INM with intravenous and/or oral pain medication.

Case report: oxaprozin and fatal toxic epidermal necrolysis.

We have presented a case of fulminating TEN with a fatal outcome. We believe there is strong probability that the TEN was caused by a propionic acid NSAID oxaprozin. This is the first reported case of TEN related to this particular agent. Toxic epidermal necrolysis has been reported with all types of NSAIDs. It appears from this case that switching from one class of nonsteroidal anti-inflammatories to another is not always without risk. Despite the class of nonsteroidal anti-inflammatory agent used, the possibility of systemic reaction cannot be excluded.

Reimbursement for out-of-state burn patients is not always lower than that for in-state patients at regional burn centers

Because burn care in the United States is regionalized, burn patients are often transported across state lines to receive their burn treatment. The authors hypothesized that there are differences between in-state and out-of-state reimbursement for burn care. This project was conducted by the American Burn Association (ABA) Government Affairs Committee through the ABA Multicenter Trials Group. Participation was open to any member of the ABA. This retrospective observational study was approved by the institutional review boards of each participating institution. Subjects were identified using registry of each site, selecting patients hospitalized for burn injuries during FY2004–FY2006 of the hospitals. Once identified by the registry, the ID numbers were used to collect billing and reimbursement data from the financial offices. Data were sorted by age (adult and pediatric), location (in state and out of state), and payor source (Medicare, Medicaid, commercial, workers compensation, and self-pay). The rate of reimbursement was calculated based on charges and recoveries. Comparisons on data of each center were performed using Students t-test with type I error <1%. Six facilities contributed data. A total of 4850 burn patients were reviewed, of whom 3941 were in-state burn patients and 909 were out-of-state burn patients. When the results from all six states were analyzed together, reimbursement for adults from Medicaid and Medicare was higher for in-state patients than for out-of-state patients. However, when analyzed by state, Medicare reimbursement between in-state and out-of-state patients did not differ significantly. In one state (Kansas), in-state Medicaid reimbursement was higher, but in two others (Arizona and Pennsylvania), in-state Medicaid reimbursement was lower than that for out-of-state reimbursement. Reimbursement for the care of children did not differ significantly based on state of residence. From these data, we conclude that there are indeed variations between in-state and out-of-state reimbursement, but those variations differ regionally. Indeed, in some cases, out-of-state reimbursement exceeds in-state reimbursement. Careful examination of these data is necessary before recommending policy change, although consideration should be given to a national policy that guarantees uniformity of reimbursement across all payors for burn patients regardless of their state of residence.