Division of Plastic and Reconstructive Surgery, University of Colorado Hospital, Aurora, Colorado.
Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.
J Reconstr Microsurg. 2020 May;36(4):276-280. doi: 10.1055/s-0039-1701029. Epub 2020 Jan 27.
More than 85 patients have received over 100 hand/arm transplants and more than 35 patients have received full or partial face transplants at institutions around the world. Given over two decades of experience in the field and in the light of successful outcomes with up to 17 years follow up time, should we still consider vascularized composite allograft (VCA) as a research/clinical investigation? We present the results of a nationwide electronic survey whose intent was to gather institutional bias with regard to this question.
An 11 question survey that was developed by VCA advisory committee of American Society of Transplantation was sent to all identified Internal Review Board chairs or directors in the United States.
We received a total of 54 responses (25.3%) to the survey. The majority (78%) of responses came from either the chairperson, director, or someone who is administratively responsible for an IRB.
Though certainly not an exhaustive investigation into each institution's preference, we present a representative sampling. The results of which favor VCA as an accepted clinical procedure given the appropriate setting. Further research is needed to fully ascertain practices at each individual institution.
在全球范围内,已有超过 85 名患者接受了超过 100 次手部/手臂移植,超过 35 名患者接受了全脸或半脸移植。鉴于该领域超过二十年的经验,以及长达 17 年的随访时间的成功结果,我们是否仍应将血管化复合移植物(VCA)视为研究/临床研究?我们提出了一项全国性电子调查的结果,该调查旨在收集机构对此问题的偏见。
由美国移植学会 VCA 咨询委员会制定的 11 个问题的调查已发送给美国所有确定的机构审查委员会主席或主任。
我们共收到 54 份(25.3%)对调查的回复。大多数(78%)的回复来自主席、主任或对 IRB 负有行政责任的人。
尽管这肯定不是对每个机构偏好的详尽调查,但我们提供了有代表性的抽样调查。结果倾向于将 VCA 视为一种可接受的临床程序,前提是在适当的环境下。需要进一步的研究来充分确定每个机构的实际情况。