Tal Konfino, Late Michael Scheflan, Jonathan Caspi, Barak Stuchiner, Ariel Tessone
{"title":"使用FixNip NRI进行乳头重建：一种新型乳头重建植入物（首次人体试验）。","authors":"Tal Konfino, Late Michael Scheflan, Jonathan Caspi, Barak Stuchiner, Ariel Tessone","doi":"10.1097/GOX.0000000000007103","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Loss of a nipple after mastectomy can adversely impact a patient's body image. This trial evaluated the performance and safety of the FixNip Nipple Reconstruction Implant (NRI), a hypodermic nipple structure designed to provide a reliable option for nipple reconstruction.</p><p><strong>Methods: </strong>Female patients 22-70 years of age with a history of breast cancer and at least 3 months postmastectomy were eligible. Nipple reconstruction with the FixNip NRI was performed. Patients were followed up for 12 months, with visits at 1 week, and 3, 6, and 12 months post surgery. Follow-up included safety evaluations, nipple projection measurements, and completion of BREAST-Q patient satisfaction questionnaires.</p><p><strong>Results: </strong>Twelve FixNip NRIs were implanted in 10 patients. Nipple projection remained stable during 12 months, with mean ± SD projections of 3.4 ± 1.6 mm at 1 week and 3.7 ± 1.6 mm at 12 months. BREAST-Q questionnaires showed medium to high patient satisfaction. No intraoperative adverse events occurred, but 1 implant was removed due to postoperative infection and dehiscence.</p><p><strong>Conclusions: </strong>FixNip NRI appears safe and feasible. Removal of the single implant may reflect the learning curve for patient selection and surgical technique. Use of this permanent implant maintained nipple projection for 12 months with medium to high patient satisfaction, suggesting promising outcomes for future reconstructions.</p>","PeriodicalId":20149,"journal":{"name":"Plastic and Reconstructive Surgery Global Open","volume":"13 9","pages":"e7103"},"PeriodicalIF":1.8000,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12456498/pdf/","citationCount":"0","resultStr":"{\"title\":\"Nipple Reconstruction Using FixNip NRI: A Novel Nipple Reconstruction Implant (First-in-human Trial).\",\"authors\":\"Tal Konfino, Late Michael Scheflan, Jonathan Caspi, Barak Stuchiner, Ariel Tessone\",\"doi\":\"10.1097/GOX.0000000000007103\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Loss of a nipple after mastectomy can adversely impact a patient's body image. This trial evaluated the performance and safety of the FixNip Nipple Reconstruction Implant (NRI), a hypodermic nipple structure designed to provide a reliable option for nipple reconstruction.</p><p><strong>Methods: </strong>Female patients 22-70 years of age with a history of breast cancer and at least 3 months postmastectomy were eligible. Nipple reconstruction with the FixNip NRI was performed. Patients were followed up for 12 months, with visits at 1 week, and 3, 6, and 12 months post surgery. Follow-up included safety evaluations, nipple projection measurements, and completion of BREAST-Q patient satisfaction questionnaires.</p><p><strong>Results: </strong>Twelve FixNip NRIs were implanted in 10 patients. Nipple projection remained stable during 12 months, with mean ± SD projections of 3.4 ± 1.6 mm at 1 week and 3.7 ± 1.6 mm at 12 months. BREAST-Q questionnaires showed medium to high patient satisfaction. No intraoperative adverse events occurred, but 1 implant was removed due to postoperative infection and dehiscence.</p><p><strong>Conclusions: </strong>FixNip NRI appears safe and feasible. Removal of the single implant may reflect the learning curve for patient selection and surgical technique. Use of this permanent implant maintained nipple projection for 12 months with medium to high patient satisfaction, suggesting promising outcomes for future reconstructions.</p>\",\"PeriodicalId\":20149,\"journal\":{\"name\":\"Plastic and Reconstructive Surgery Global Open\",\"volume\":\"13 9\",\"pages\":\"e7103\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-09-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12456498/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Plastic and Reconstructive Surgery Global Open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1097/GOX.0000000000007103\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/9/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Plastic and Reconstructive Surgery Global Open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/GOX.0000000000007103","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"SURGERY","Score":null,"Total":0}
Nipple Reconstruction Using FixNip NRI: A Novel Nipple Reconstruction Implant (First-in-human Trial).
Background: Loss of a nipple after mastectomy can adversely impact a patient's body image. This trial evaluated the performance and safety of the FixNip Nipple Reconstruction Implant (NRI), a hypodermic nipple structure designed to provide a reliable option for nipple reconstruction.
Methods: Female patients 22-70 years of age with a history of breast cancer and at least 3 months postmastectomy were eligible. Nipple reconstruction with the FixNip NRI was performed. Patients were followed up for 12 months, with visits at 1 week, and 3, 6, and 12 months post surgery. Follow-up included safety evaluations, nipple projection measurements, and completion of BREAST-Q patient satisfaction questionnaires.
Results: Twelve FixNip NRIs were implanted in 10 patients. Nipple projection remained stable during 12 months, with mean ± SD projections of 3.4 ± 1.6 mm at 1 week and 3.7 ± 1.6 mm at 12 months. BREAST-Q questionnaires showed medium to high patient satisfaction. No intraoperative adverse events occurred, but 1 implant was removed due to postoperative infection and dehiscence.
Conclusions: FixNip NRI appears safe and feasible. Removal of the single implant may reflect the learning curve for patient selection and surgical technique. Use of this permanent implant maintained nipple projection for 12 months with medium to high patient satisfaction, suggesting promising outcomes for future reconstructions.
期刊介绍：
Plastic and Reconstructive Surgery—Global Open is an open access, peer reviewed, international journal focusing on global plastic and reconstructive surgery.Plastic and Reconstructive Surgery—Global Open publishes on all areas of plastic and reconstructive surgery, including basic science/experimental studies pertinent to the field and also clinical articles on such topics as: breast reconstruction, head and neck surgery, pediatric and craniofacial surgery, hand and microsurgery, wound healing, and cosmetic and aesthetic surgery. Clinical studies, experimental articles, ideas and innovations, and techniques and case reports are all welcome article types. Manuscript submission is open to all surgeons, researchers, and other health care providers world-wide who wish to communicate their research results on topics related to plastic and reconstructive surgery. Furthermore, Plastic and Reconstructive Surgery—Global Open, a complimentary journal to Plastic and Reconstructive Surgery, provides an open access venue for the publication of those research studies sponsored by private and public funding agencies that require open access publication of study results. Its mission is to disseminate high quality, peer reviewed research in plastic and reconstructive surgery to the widest possible global audience, through an open access platform. As an open access journal, Plastic and Reconstructive Surgery—Global Open offers its content for free to any viewer. Authors of articles retain their copyright to the materials published. Additionally, Plastic and Reconstructive Surgery—Global Open provides rapid review and publication of accepted papers.
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