ArticleBMJ open2025
Protocol for single-arm clinical trial evaluating medical grade polycaprolactone breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgery.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05437757 (Clinical Trial Evaluating Medical-grade Polycaprolactone-PCL Breast Scaffold Implantation With Autologous Fat Grafting for Breast Implant Revision and Congenital Defect Correction Surgery), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Trial Evaluating Medical-grade Polycaprolactone-PCL Breast Scaffold Implantation With Autologous Fat Grafting for Breast Implant Revision and Congenital Defect Correction Surgery
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRevision 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05437757.
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