ARTIFICIAL DERMIS FOR MAJOR BURNS - A MULTI-CENTER RANDOMIZED CLINICAL-TRIAL

ARTIFICIAL DERMIS FOR MAJOR BURNS - A MULTI-CENTER RANDOMIZED CLINICAL-TRIAL
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DOI:
10.1097/00000658-198809000-00008
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发表时间:
1988-09-01
期刊:
影响因子:
9
通讯作者:
ZAWACKI, B
ZAWACKI, B
中科院分区:
医学1区
文献类型:
--
作者:
HEIMBACH, D;LUTERMAN, A;ZAWACKI, B

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本通讯介绍了一个11中心的前瞻性随机试验,使用伯克和Yannas发明的人工真皮。在伤后7天内接受初次切除和移植的危及生命的烧伤患者具有可比部位,随机接受人工真皮(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,并在移植后随访存活患者1年。对106例患者的139个部位进行了研究。平均烧伤面积为46.5 ± 15%平均全身表面积(TBSA)。总死亡率为13%,平均住院时间为68 ± 45天。所有比较部位的人工真皮取用率中位数为80%,而95%,但取用率与所有非自体移植对照材料相当。随着研究者对人工真皮材料的熟悉,人工真皮的结果略有改善。研究部位的供体部位厚度平均为.006“+/-.002”,而对照部位为.013“+/-.018”(p <.0001),表皮供体部位平均提前4天愈合(10 +/- 6 vs. 14 +/- 8天)(p <.0001)。随着伤口在第一年的成熟,患者和外科医生都认为两个部位在外观和功能上变得更加相似。在研究完成时,人工真皮的增生性瘢痕较少,并且更多的患者更喜欢人工真皮而不是对照移植物。具有表皮移植物的人造真皮提供了至少与目前可用的皮肤移植技术一样令人满意的永久覆盖物,并且使用更薄的供体移植物和愈合更快的供体部位。图像
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. Images