van Zuijlen P P, Vloemans J F, van Trier A J, Suijker M H, van Unen E, Groenevelt F, Kreis R W, Middelkoop E
Burn Center, the Department of Surgery, Red Cross Hospital and the Dutch Burns Foundation, Beverwijk, The Netherlands.
Plast Reconstr Surg. 2001 Dec;108(7):1938-46. doi: 10.1097/00006534-200112000-00014.
Tissue engineering and dermal substitution are currently prominent topics of wound-healing research. However, no extensive clinical trials with objective evaluation criteria have been published so far that support the clinical effectiveness of dermal equivalents in the long term. The dermal substitute that is discussed here is derived from bovine collagen and elastin-hydrolysate and has been shown to improve skin elasticity during a short-term clinical follow-up of scar reconstructions. In this study we will present the long-term outcome by means of objective and subjective scar assessment tools for dermal substitution in acute burn wounds and scar reconstructions. In a clinical trial, an intraindividual comparison was performed between the conventional split-thickness autograft and a combination of the collagen/elastin substitute with an autograft. After 1 year, scars were evaluated by the Cutometer SEM 474 for objective elasticity measurements and by planimetry to establish scar contraction. An independent observer subjected scars to a generally accepted clinical scar assessment tool: the Vancouver Scar Scale. In addition, patients gave their impression of the outcome. Forty-two paired burn wounds and 44 paired scar reconstructions were included and evaluated 1 year after surgery. Although substituted scar reconstructions demonstrated an elasticity improvement of approximately 20 percent compared with control wounds, no statistically significant differences were found for skin elasticity, scar contraction, Vancouver Scar Scale, and patient's impression in both categories after 1 year. An extensive long-term follow-up shows that the dermal substitute, which was proven effective in a clinical trial on a short-term basis, did not yield statistical evidence for a long-term clinical effectiveness of dermal substitution.
组织工程和皮肤替代物是目前伤口愈合研究的热门话题。然而,迄今为止尚未发表过具有客观评估标准的大规模临床试验来支持皮肤替代物的长期临床有效性。本文所讨论的皮肤替代物源自牛胶原蛋白和弹性蛋白水解物,在瘢痕重建的短期临床随访中已显示出能改善皮肤弹性。在本研究中,我们将通过客观和主观的瘢痕评估工具来呈现急性烧伤创面和瘢痕重建中皮肤替代物的长期效果。在一项临床试验中,对传统的中厚自体皮片与胶原蛋白/弹性蛋白替代物加自体皮片的组合进行了个体内比较。1年后,使用Cutometer SEM 474进行客观弹性测量,并通过面积测量法评估瘢痕收缩情况,以评估瘢痕。一名独立观察者使用普遍接受的临床瘢痕评估工具:温哥华瘢痕量表对瘢痕进行评估。此外,患者也给出了他们对结果的印象。纳入了42对烧伤创面和44对瘢痕重建病例,并在术后1年进行评估。尽管替代瘢痕重建与对照创面相比弹性改善了约20%,但1年后在皮肤弹性、瘢痕收缩、温哥华瘢痕量表以及两类患者的印象方面均未发现统计学上的显著差异。广泛的长期随访表明,在短期临床试验中被证明有效的皮肤替代物,并未提供皮肤替代物长期临床有效性的统计学证据。