title: SERI surgical scaffold, prospective clinical trial of a silk-derived biological scaffold in two-stage breast reconstruction: 1-year data.
abstract: BACKGROUND
  SERI Surgical Scaffold is a long-term bioresorbable silk-derived biological scaffold developed to provide soft-tissue support and repair.
  
  
  METHODS
  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.
  
  
  RESULTS
  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; p < 0.0001). 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.
  
  
  CONCLUSIONS
  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.
  
  
  METHODS
  Therapeutic, IV.
authors.affiliation: Chicago, Ill.; South Pasadena, Los Angeles, and San Francisco, Calif.; McLean, Va.; Medford, Mass.; and Portland and Eugene, Ore. From the Northwestern Specialists in Plastic Surgery; private practice; University of Southern California Keck School of Medicine; California-Pacific Medical Center; Aesthetic Center for Plastic Surgery; Cedars Sinai Medical Center; Silk Therapeutics, Inc.; and Oregon Health Science University.
authors.forename: Neil A
authors.initials: NA
authors.lastname: Fine
authors.forename: Max
authors.initials: M
authors.lastname: Lehfeldt
authors.forename: John E
authors.initials: JE
authors.lastname: Gross
authors.forename: Susan
authors.initials: S
authors.lastname: Downey
authors.forename: Gabriel M
authors.initials: GM
authors.lastname: Kind
authors.forename: Gloria
authors.initials: G
authors.lastname: Duda
authors.forename: David
authors.initials: D
authors.lastname: Kulber
authors.forename: Rebecca
authors.initials: R
authors.lastname: Horan
authors.forename: Jeff
authors.initials: J
authors.lastname: Ippolito
authors.forename: Mark
authors.initials: M
authors.lastname: Jewell
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000532:radiotherapy / Q000601:surgery; D003131:Combined Modality Therapy; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006406:Hematoma / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D057910:Implant Capsular Contracture / Q000453:epidemiology; D008297:Male; D016462:Mammaplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D008413:Mastitis / Q000453:epidemiology; D008875:Middle Aged; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D049291:Seroma / Q000453:epidemiology / Q000209:etiology; D047011:Silk; D013526:Surgical Mesh / Q000009:adverse effects; D013530:Surgical Wound Infection / Q000453:epidemiology; D015625:Tissue Expansion Devices; D054457:Tissue Scaffolds / Q000009:adverse effects
chemical_list: D047011:Silk