title: The use of acellular dermal matrices in two-stage expander/implant reconstruction:  a multicenter, blinded, randomized controlled trial.
abstract: BACKGROUND
  Current efficacy data supporting the routine use of acellular dermal matrices in postmastectomy tissue expander/implant reconstruction are limited. A multicenter, blinded, randomized controlled study was designed to evaluate the effectiveness of acellular dermal matrix in the setting of tissue expander/implant reconstruction. The primary objective of the study was to determine whether the use of matrix would decrease patient-reported postoperative pain. The secondary objective was to determine whether its use would accelerate the rate of postoperative expansion.
  
  
  METHODS
  The randomized controlled trial was conducted at two U.S. centers from 2008 to 2011. Immediately following mastectomy, all patients were randomized to one of two treatment arms: (1) acellular dermal matrix-assisted, tissue expander/implant reconstruction; and (2) submuscular tissue expander/implant placement. All patients were blinded to their treatment arm.
  
  
  RESULTS
  One hundred eight consented to participate; 38 were excluded prior to randomization. In total, 70 patients were randomized. There were no differences seen in immediate postoperative pain (p = 0.19) or pain during the expansion phase (p = 0.65) between treatment arms. There was similarly no difference in postoperative narcotic use (p = 0.38). The rate of postoperative expansion did not differ between groups (p = 0.83).
  
  
  CONCLUSIONS
  The results suggest that the use of acellular dermal matrix in the setting of tissue expander/implant reconstruction neither reduces postoperative pain nor accelerates the rate of postoperative expansion. An examination of its efficacy in improving long-term outcomes following tissue expander/implant reconstruction is warranted.
authors.affiliation: New York, N.Y.; and Chapel Hill, N.C. From the Plastic and Reconstructive Surgery Service, Department of Surgery, and the Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center; the Division of Plastic and Reconstructive Surgery, Department of Surgery, and the Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill; and the Lineberger Comprehensive Cancer Center.
authors.forename: Colleen M
authors.initials: CM
authors.lastname: McCarthy
authors.forename: Clara N
authors.initials: CN
authors.lastname: Lee
authors.forename: Eric G
authors.initials: EG
authors.lastname: Halvorson
authors.forename: Elyn
authors.initials: E
authors.lastname: Riedel
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Pusic
authors.forename: Babak J
authors.initials: BJ
authors.lastname: Mehrara
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Disa
mesh_terms: D062088:Acellular Dermis; D000328:Adult; D000368:Aged; D016058:Analgesia, Patient-Controlled; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D019928:Breast Implantation / Q000379:methods*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003094:Collagen / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004954:Esthetics; D005260:Female; D006801:Humans; D057910:Implant Capsular Contracture / Q000453:epidemiology; D016462:Mammaplasty / Q000379:methods* / Q000523:psychology; D008408:Mastectomy; D008875:Middle Aged; D009294:Narcotics / Q000008:administration & dosage / Q000627:therapeutic use; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control*; D017060:Patient Satisfaction; D011788:Quality of Life; D016037:Single-Blind Method; D013997:Time Factors; D015625:Tissue Expansion Devices; D016896:Treatment Outcome
chemical_list: C440568:Alloderm; D000970:Antineoplastic Agents; D009294:Narcotics; D003094:Collagen