Department of Dermatology, University Hospital of Zürich, Zürich, Switzerland.
Dermatology. 2010;221(4):365-72. doi: 10.1159/000321333. Epub 2010 Nov 11.
Approximately 20% of leg ulcers remain unresponsive to the best conservative standard of care. So far, these patients could either receive conventional skin grafts or had to accept their intractable wound. Skin substitutes from cell culture may represent a promising alternative to heal a major part of these patients on a non-surgical, potentially more cost-effective basis.
To systematically evaluate the first 68 patients treated in Switzerland (Swiss EpiDex® field trial 2004-2008).
Retrospective study on EpiDex treatment of a complete consecutive series of 68 patients with chronic wounds (66 chronic leg ulcers, 2 sores) unresponsive to best conservative standard of care. The primary end point was complete wound closure within 9 months after transplantation, the secondary end points change of wound surface area, pain reduction and overall judgement by the patient. Adverse effects were infection, dermatitis and others. Calculation of treatment costs was made.
By the end of the study, 50/68 (74%) of patients had their wound completely healed [venous 29/37 (78%); mixed 7/9 (78%); others 14/22 (64%)]; 10/68 (15%) had the wound surface area reduced by >50%, and 8/68 (12%) did not respond to the EpiDex treatment. Wound pain disappeared completely in 78% and partially in 13%. Fifteen patients (22%) received antibiotics for wound infection, and 2 (3%) developed dermatitis (not related to the local therapy). Average treatment costs for venous ulcers amounted to EUR 5,357, compared to EUR 5,722-8,622 reimbursed according to the German DRG system (2010) for an in-patient skin graft.
EpiDex may effectively heal up to three quarters of recalcitrant chronic leg ulcers. Thus, it represents an intermediate step to avoid costly in-patient split-skin mesh graft treatments. Patients remain mobilized, and a donor site is avoided. Large wound size or a necrotic wound bed limit the use of EpiDex. Otherwise, it offers the opportunity to avoid conventional skin grafts in a significant number of chronic leg ulcer patients.
约 20%的腿部溃疡对最佳保守标准治疗没有反应。到目前为止，这些患者要么接受传统的皮肤移植，要么只能接受他们的顽固性伤口。细胞培养的皮肤替代物可能代表了一种有前途的选择，可以在非手术的基础上，以更具成本效益的方式治愈这些患者中的很大一部分。
系统评估 2004 年至 2008 年在瑞士进行的 68 例患者（瑞士 EpiDex®现场试验）。
回顾性研究 EpiDex 治疗 68 例慢性伤口（66 例慢性腿部溃疡，2 例褥疮）对最佳保守标准治疗无反应的完全连续系列患者。主要终点是移植后 9 个月内完全愈合伤口，次要终点是伤口面积变化、疼痛减轻和患者整体判断。不良反应为感染、皮炎等。计算治疗费用。
研究结束时，50/68（74%）的患者伤口完全愈合[静脉 29/37（78%）；混合 7/9（78%）；其他 14/22（64%）]；10/68（15%）的患者伤口面积减少>50%，8/68（12%）的患者对 EpiDex 治疗无反应。78%的患者完全消除了伤口疼痛，13%的患者部分消除了疼痛。15 例（22%）患者因伤口感染接受抗生素治疗，2 例（3%）发生皮炎（与局部治疗无关）。静脉溃疡的平均治疗费用为 5357 欧元，而根据德国 DRG 系统（2010 年），住院皮肤移植的报销费用为 5722-8622 欧元。
EpiDex 可有效治愈高达四分之三的难治性慢性腿部溃疡。因此，它是避免昂贵的住院分体式网状移植治疗的中间步骤。患者保持活动，避免供体部位。伤口大或坏死伤口床限制了 EpiDex 的使用。否则，它为避免大量慢性腿部溃疡患者进行传统皮肤移植提供了机会。
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