Department of Plastic and Reconstructive Surgery, Okayama University Hospital.
Nagoya J Med Sci. 2020 Feb;82(1):39-45. doi: 10.18999/nagjms.82.1.39.
The popularity of a sling method using biomaterial sheets for immediate breast reconstruction based on prosthesis has been increasing in western countries. However, acellular dermal matrix, which is representative of the biomaterial sheet, is not available and the sling method also has not been accepted in Japan. We focused on a new bioabsorbable sheet (NEOVEIL sheet) as a substitute for the sling method and report a prospective study protocol to assess the safety and effectiveness of this material. This was an ongoing, single center, open-label, single-arm study. Inclusion criteria and exclusion criteria are defined restrictively. If the surgeon determined that the perfusion of skin envelope after mastectomy is poor, the surgical procedure can be modified and that patient was excluded from the study. The primary outcome was the incidence of tissue expansion or implant explantation occurring within 1 month after surgery. The secondary outcomes are as follows: (1) aesthetic outcome using a rating scale; (2) symmetry of the nipple areolar complex position; (3) patient reported outcomes using BREAST-Q; (4) pain intensity using the Visual Analog Scale; (5) histology of the capsule around the tissue expander; (6) inflation volume at the first stage and overall inflation time of expansion; and (7) other adverse events regarding the surgery. This study will determine the safety and effectiveness of the sling method using a NEOVEIL sheet in Japanese women.
基于假体的生物材料片即时乳房重建吊带法在西方国家越来越受欢迎。然而,细胞外基质(代表生物材料片)在日本不可用,吊带法也未被接受。我们专注于一种新的可吸收片(NEOVEIL 片)作为吊带法的替代品,并报告了一项评估该材料安全性和有效性的前瞻性研究方案。这是一项正在进行的、单中心、开放性、单臂研究。纳入标准和排除标准定义得很严格。如果外科医生确定乳房切除术后皮肤包被的灌注不良,则可以修改手术程序,将该患者排除在研究之外。主要结局是术后 1 个月内发生组织扩张或植入物取出的发生率。次要结局如下:(1)使用评分量表评估美学结果;(2)乳头乳晕复合体位置的对称性;(3)BREAST-Q 患者报告的结果;(4)使用视觉模拟量表评估疼痛强度;(5)组织扩张器周围胶囊的组织学;(6)第一阶段的膨胀量和扩张的总膨胀时间;(7)与手术相关的其他不良事件。本研究将确定在日本女性中使用 NEOVEIL 片的吊带法的安全性和有效性。
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