title: The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial.
abstract: BACKGROUND
  Recent literature has focused on the advantages and disadvantages of using acellular dermal matrix in breast reconstruction. Many of the reported data are from low level-of-evidence studies, leaving many questions incompletely answered. The present randomized trial provides high-level data on the incidence and severity of complications in acellular dermal matrix breast reconstruction between two commonly used types of acellular dermal matrix.
  
  
  METHODS
  A prospective randomized trial was conducted to compare outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix. The impact of body mass index, smoking, diabetes, mastectomy type, radiation therapy, and chemotherapy on outcomes was analyzed. Acellular dermal matrix biointegration was analyzed clinically and histologically. Patient satisfaction was assessed by means of preoperative and postoperative surveys. Logistic regression models were used to identify predictors of complications.
  
  
  RESULTS
  This article reports on the study design, surgical technique, patient characteristics, and preoperative survey results, with outcomes data in a separate report. After 2.5 years, we successfully enrolled and randomized 128 patients (199 breasts). The majority of patients were healthy nonsmokers, with 41 percent of patients receiving radiation therapy and 49 percent receiving chemotherapy. Half of the mastectomies were prophylactic, with nipple-sparing mastectomy common in both cancer and prophylactic cases. Preoperative survey results indicate that patients were satisfied with their premastectomy breast reconstruction education.
  
  
  CONCLUSIONS
  Results from the Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial will assist plastic surgeons in making evidence-based decisions regarding acellular dermal matrix-assisted tissue expander breast reconstruction.
  
  
  METHODS
  Therapeutic, II.
authors.affiliation: Salt Lake City, Utah; and Springfield, Ill. From the Division of Plastic and Reconstructive Surgery, the Department of Surgery, the Division of Epidemiology, Department of Internal Medicine, and the Department of Pathology, University of Utah School of Medicine; and the Institute for Plastic Surgery, Southern Illinois University School of Medicine.
authors.forename: Jayant P
authors.initials: JP
authors.lastname: Agarwal
authors.forename: Shaun D
authors.initials: SD
authors.lastname: Mendenhall
authors.forename: Layla A
authors.initials: LA
authors.lastname: Anderson
authors.forename: Jian
authors.initials: J
authors.lastname: Ying
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Boucher
authors.forename: Ting
authors.initials: T
authors.lastname: Liu
authors.forename: Leigh A
authors.initials: LA
authors.lastname: Neumayer
mesh_terms: D062088:Acellular Dermis; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000601:surgery*; D005260:Female; D006801:Humans; D016462:Mammaplasty / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D016037:Single-Blind Method; D055815:Young Adult