Heimbach D, Luterman A, Burke J, Cram A, Herndon D, Hunt J, Jordan M, McManus W, Solem L, Warden G
University of Washington, Seattle.
Ann Surg. 1988 Sep;208(3):313-20. doi: 10.1097/00000658-198809000-00008.
This communication presents an 11-center prospective randomized trial using the artificial dermis invented by Burke and Yannas. Patients with life-threatening burns who underwent primary excision and grafting within 7 days of injury had comparable sites randomized to receive either the artificial dermis (study site) or the investigator's usual skin grafting material (control site). Control materials were autograft, allograft, xenograft, or a synthetic dressing. Epidermal grafts were applied to the study site during a second operation, and surviving patients were followed for 1 year after grafting. One hundred thirty-nine sites on 106 patients were studied. Mean burn size was 46.5 +/- 15% mean total body surface (TBSA). Overall mortality was 13%, and mean hospital stay was 68 +/- 45 days. Median artificial dermis take was 80% compared with 95% for all comparative sites, but the take was equivalent to that of all nonautograft control materials. Results with the artificial dermis improved slightly as the investigators became more familiar with the material. Donor site thickness for the study site averaged .006'' +/- .002'' compared to .013'' +/- .018'' for control (p less than .0001) and the epidermal donor site healed an average of 4 days sooner (10 +/- 6 vs. 14 +/- 8 days) (p less than .0001). As the wounds matured during the first year, both patients and surgeons felt that both sites became more comparable in appearance and function. At the completion of the study, there was less hypertrophic scarring of the artificial dermis, and more patients preferred the artificial dermis to the control graft. Artificial dermis with an epidermal graft provides a permanent cover that is at least as satisfactory as currently available skin grafting techniques, and uses donor grafts that are thinner and donor sites that heal faster.
本通讯介绍了一项使用伯克和扬纳斯发明的人工真皮进行的11中心前瞻性随机试验。在受伤7天内接受初次切除和植皮的危及生命的烧伤患者，将可比部位随机分组，分别接受人工真皮（研究部位）或研究者常用的皮肤移植材料（对照部位）。对照材料为自体移植物、同种异体移植物、异种移植物或合成敷料。在第二次手术期间，将表皮移植物应用于研究部位，存活患者在植皮后随访1年。对106例患者的139个部位进行了研究。平均烧伤面积为平均全身表面积（TBSA）的46.5±15%。总体死亡率为13%，平均住院时间为68±45天。人工真皮的平均植入率为80%，而所有对照部位为95%，但该植入率与所有非自体移植对照材料相当。随着研究者对该材料越来越熟悉，人工真皮的效果略有改善。研究部位的供皮区厚度平均为0.006英寸±0.002英寸，而对照部位为0.013英寸±0.018英寸（p＜0.0001），表皮供皮区愈合平均提前4天（10±6天对14±8天）（p＜0.0001）。在第一年伤口成熟过程中，患者和外科医生都认为两个部位在外观和功能上变得更具可比性。在研究结束时，人工真皮部位的增生性瘢痕较少，更多患者更喜欢人工真皮而非对照移植物。带表皮移植物的人工真皮提供了一种永久性覆盖物，至少与目前可用的皮肤移植技术一样令人满意，并且使用的供体移植物更薄，供皮区愈合更快。
