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
Introduction 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)...
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BMJ Publishing Group
2025-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/4/e088151.full |
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| author | Matthew Cheng Michael Wagels Gwenda Chapman Owen Ung |
| author_facet | Matthew Cheng Michael Wagels Gwenda Chapman Owen Ung |
| author_sort | Matthew Cheng |
| collection | DOAJ |
| description | Introduction 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.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. |
| format | Article |
| id | doaj-art-b15a157129ac4e7fb0e9e90c13091c41 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-b15a157129ac4e7fb0e9e90c13091c412025-08-20T02:57:13ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2024-088151Protocol for single-arm clinical trial evaluating medical grade polycaprolactone breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgeryMatthew Cheng0Michael Wagels1Gwenda Chapman2Owen Ung3Division of Infectious Diseases, McGill Univesrity Health Centre, Montréal, Quebec, CanadaDepartment of Plastic & Reconstructive Surgery, Princess Alexandra Hospital, Woolloongabba, Queensland, AustraliaCentral Queensland Public Health Unit, Central Queensland Hospital and Health Service, Rockhampton, Queensland, AustraliaBreast and Endocrine Surgery, Comprehensive Breast Cancer Institute (CBCI), Royal Brisbane and Women’s Hospital, Herston, Queensland, AustraliaIntroduction 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.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.https://bmjopen.bmj.com/content/15/4/e088151.full |
| spellingShingle | Matthew Cheng Michael Wagels Gwenda Chapman Owen Ung 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/15/4/e088151.full |
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