SERI surgical scaffold, prospective clinical trial of a silk-derived biological scaffold in two-stage breast reconstruction: 1-year data
| Autor: | John Gross, Susan E. Downey, Gabriel M. Kind, Mark L. Jewell, David A. Kulber, Gloria Duda, Jeff Ippolito, Rebecca Horan, Neil A. Fine, Max R. Lehfeldt |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Scaffold Mammaplasty Silk Breast Neoplasms Mastitis Postoperative Complications Implant Capsular Contracture medicine Humans Surgical Wound Infection Prospective Studies Stage (cooking) Aged Hematoma Tissue Scaffolds business.industry Tissue Expansion Devices Follow up studies Middle Aged Surgical Mesh Combined Modality Therapy Surgery Clinical trial Equipment failure Seroma Multicenter study Patient Satisfaction Equipment Failure Female Radiotherapy Adjuvant Breast reconstruction business Follow-Up Studies |
| Zdroj: | Plastic and reconstructive surgery. 135(2) |
| ISSN: | 1529-4242 |
| Popis: | SERI Surgical Scaffold is a long-term bioresorbable silk-derived biological scaffold developed to provide soft-tissue support and repair.SURE-001 (ClinicalTrials.gov identification no. NCT01256502) is a prospective, single-arm study in the United States of patients undergoing two-stage, implant-based breast reconstruction using SERI.A total of 139 patients were enrolled and will be followed for 2 years; in this article, the authors report interim data on 71 patients followed for 1 year. Investigator satisfaction scores (mean ± SD) at 6 and 12 months were 9.2 ± 0.98 and 9.4 ± 0.91, respectively (10 = very satisfied). SERI was rated easy/very easy to use in 98 percent or more of cases across five categories in stage I surgery. Patient satisfaction with the treated breast(s) (mean ± SD) was higher at 6 (4.3 ± 0.87; 5 = very satisfied) and 12 months (4.5 ± 0.82) compared with screening (3.6 ± 1.09; p0.0001). Key complication rates (per breast) were tissue necrosis (6.7 percent), seroma (5.7 percent), hematoma (4.8 percent), implant loss (3.8 percent), capsular contracture (1.9 percent), and breast infection (1.0 percent). None were attributed to SERI by the investigators. In 13 patients (14 breasts) who underwent unplanned radiation therapy, one complication was reported.In this interim report, high levels of investigator and patient satisfaction, and ease of use of SERI were reported. Prospectively collected complication rates were similar to those reported in primarily retrospective studies of two-stage, implant-based breast reconstructions using other implantable soft-tissue support materials such as acellular dermal matrices.Therapeutic, IV. |
| Databáze: | OpenAIRE |
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