Skin Substitutes and Wound Healing: Current Status and Challenges

David Eisenbud, MD, CWS; Ngan F. Huang, BS; Sunny Luke, DSc; Melvin Silberklang, PhD

Disclosures

Wounds. 2004;16(1) 

In This Article

Economic/Reimbursement Issues

Published calculations of cost effectiveness of treatments are problematic and are often fraught with subjectivity. The cost of an unhealed wound may reach far beyond actual physician, hospital, and medical equipment bills and extend to foregone wages, diminished productivity by the employee, and additional direct medical costs for complications of nonhealing, such as infection. Further, some of the costs, while quite real, may be difficult or impossible to measure. Thus it is not surprising that various analyses of the cost-effectiveness of cell-based wound therapy or skin substitutes have reached conflicting conclusions.

Some authors are skeptical of high-cost treatments. Marston,[84] for example, estimated the cost to heal small and very large venous ulcers to be about $1300 and $5300, respectively. Given this range, it is not obvious that a $1000 sheet of bio-engineered skin can show cost effectiveness. Harding and colleagues[85] performed a pooled analysis of 15 pressure ulcer and 12 leg ulcer studies and noted that relatively indiscriminate use of bioengineered skin products was quite inefficient. Sibbald modeled the healing and economic consequences of venous ulcer treatment with compression with or without one application of skin substitute;[86] his conclusion was that cost effectiveness was marginal, but was more pronounced in patients with ulcers of longer duration.

Other studies have reached exactly opposite conclusions and have stressed the economic benefits of cell-based wound therapy.[87] A review of 270 patients with venous ulcers included only the direct costs of care -- physician visits, procedures, management of complications, dressings -- and found that LSE-treated patients cost an average of $20,041 to heal compared with $27,493 for patients managed with Unna boot therapy.[88] Kirsner, et al.,[89] calculated that in their experience recalcitrant venous ulcers could be healed for approximately $16,000 using either LSE or by "standard" measures not including bioengineered skin products; the savings from faster healing and fewer complications were equaled by the cost of the cell-based wound therapy. Diabetic foot ulcers were treated less expensively using LSE compared with "standard" dressings in the Netherlands, and ulcer-free time was increased along with decreasing amputation incidence.[90] Nunez-Guttierrez and colleagues compared 39 severely burned patients treated by standard means with 32 similar patients whose regimen included the application of frozen cultured epithelial allograft.[70] Among the highest body surface area burns, patient survival was increased, and hospital stay decreased by over 20 percent as a result of quicker healing and fewer complications.

In the authors' opinion, the bulk of evidence supports the contention that bioengineered skin products are cost-effective therapies for appropriately selected patients. The patients who would benefit the most are presumably those whose wound healing would be significantly delayed under standard therapy or whose wounds are most recalcitrant to standard therapy, and several researchers are attempting to define criteria by which to prospectively identify such patient subpopulations.[91,92,93]

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