Cheng Matthew, Chapman Gwenda, Wagels Michael, Ung Owen
Department of Plastic and Reconstructive Surgery, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.
Centre for Regenerative Medicine, Queensland University of Technology Institute of Health and Biomedical Innovation, Brisbane, Queensland, Australia.
BMJ Open. 2025 Apr 29;15(4):e088151. doi: 10.1136/bmjopen-2024-088151.
Revision surgery following primary breast augmentation is common due to well-reported long-term limitations of permanent silicone implants. There are limited options for revision breast augmentation which avoids using silicone implants. Scaffold-guided breast tissue engineering (SGBTE) is a novel technique which uses breast scaffolds additively manufactured from medical grade polycaprolactone (mPCL), which is implanted and filled with autologous fat graft. This approach avoids limitations as observed with permanent silicone breast implants as the scaffold is porous and biodegradable. This clinical trial evaluates the safety and efficacy of SGBTE.
This study is an open, single-arm, monocentric, interventional, prospective clinical trial. The trial is being conducted at the Royal Brisbane and Women's Hospital (RBWH) in Herston (Queensland, Australia) of the Metro North Health Service. The trial investigates 15-20 women who require breast implant surgery and/or congenital breast defect correction surgery, where a mPCL breast scaffold is implanted and filled with autologous fat graft. The primary endpoint is postoperative device safety by assessing the rate of adverse device effect rate. Secondary endpoints include general adverse event frequency and severity, number of revision surgeries, general surgical outcomes and complications, patient-reported outcomes and volume replacement outcomes.
The RBWH Human Research Ethics Committee (EC00172) has approved this clinical trial (ethics approval: HREC/2021/QRBW/79906). Findings from this clinical trial will evaluate the safety and efficacy of implanting mPCL scaffolds filled with autologous fat graft. The results of this clinical trial will be published in a peer-reviewed journal and presented at scientific meetings.
NCT05437757.
由于永久性硅胶植入物存在诸多已报道的长期局限性，初次隆胸后的修复手术很常见。避免使用硅胶植入物的隆胸修复选择有限。支架引导式乳房组织工程（SGBTE）是一种新技术，它使用由医用级聚己内酯（mPCL）增材制造的乳房支架，该支架被植入并填充自体脂肪移植组织。这种方法避免了永久性硅胶乳房植入物所观察到的局限性，因为该支架是多孔且可生物降解的。这项临床试验评估了SGBTE的安全性和有效性。
本研究是一项开放、单臂、单中心、干预性、前瞻性临床试验。该试验正在澳大利亚昆士兰州赫斯顿的皇家布里斯班和妇女医院（RBWH）进行，隶属于北地铁健康服务中心。该试验对15至20名需要乳房植入手术和/或先天性乳房缺陷矫正手术的女性进行研究，在这些手术中植入mPCL乳房支架并填充自体脂肪移植组织。主要终点是通过评估不良器械效应率来确定术后器械安全性。次要终点包括一般不良事件的频率和严重程度、修复手术的次数、一般手术结果和并发症、患者报告的结果以及容量替代结果。
RBWH人类研究伦理委员会（EC00172）已批准该临床试验（伦理批准号：HREC/2021/QRBW/79906）。这项临床试验的结果将评估植入填充自体脂肪移植组织的mPCL支架的安全性和有效性。该临床试验的结果将发表在同行评审期刊上，并在科学会议上展示。
NCT05437757。
