title: Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial.
abstract: BACKGROUND
  AeroForm is a new type of remote-controlled, needle-free, carbon dioxide-based expander involving a potentially faster method of tissue expansion. Results are presented here from the AirXpanders Patient Activated Controlled Tissue Expander pivotal trial comparing AeroForm to saline tissue expanders.
  
  
  METHODS
  Women undergoing two-stage breast reconstruction were randomized at 17 U.S. sites in this U.S. Food and Drug Administration-approved investigational device exemption trial. Expansion in the investigational arm was performed by the patient in 10-cc increments up to 30 cc/day of carbon dioxide and in the control arm by the physician with periodic bolus injections of saline. Safety endpoints, expansion and reconstruction times, pain, and satisfaction were assessed.
  
  
  RESULTS
  One hundred fifty women were treated: 98 with carbon dioxide expanders (n = 168) and 52 with saline expanders (n = 88). The treatment success rate (all breasts exchanged successfully excluding non-device-related failures) was 96.1 percent for carbon dioxide and 98.8 percent for saline. Median time to full expansion and completion of the second-stage operation was 21.0 and 108.5 days (carbon dioxide) versus 46.0 and 136.5 days (saline), respectively, with a similar rate of overall complications. Ease of use for the carbon dioxide expander was rated high by patients (98 percent) and physicians (90 percent).
  
  
  CONCLUSIONS
  The AirXpanders Patient Activated Controlled Tissue Expander trial results demonstrate that a carbon dioxide-based expander is an effective method of tissue expansion with a similar overall adverse event rate compared to saline expanders, and provides a more convenient and expedient expansion.
  
  
  METHODS
  Therapeutic, I.
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Ascherman
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: Kamakshi
authors.initials: K
authors.lastname: Zeidler
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: Kerry A
authors.initials: KA
authors.lastname: Morrison
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: James Z
authors.initials: JZ
authors.lastname: Appel
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: R L
authors.initials: RL
authors.lastname: Berkowitz
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: John
authors.initials: J
authors.lastname: Castle
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: Amy
authors.initials: A
authors.lastname: Colwell
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: Yoon
authors.initials: Y
authors.lastname: Chun
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: Debra
authors.initials: D
authors.lastname: Johnson
authors.affiliation: New York, N.Y.; Campbell, Sacramento, and Corte Madera, Calif.; Charlotte, N.C.; and Worcester and Boston, Mass.|From the Division of Plastic Surgery, Department of Surgery, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetic and Reconstructive Plastic Surgery; The Plastic Surgery Center; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital; and Brigham and Women's Faulkner Hospital, Harvard Medical School.
authors.forename: Khashayar
authors.initials: K
authors.lastname: Mohebali
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002245:Carbon Dioxide / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007327:Insufflation; D016462:Mammaplasty / Q000379:methods*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D011446:Prospective Studies; D012965:Sodium Chloride / Q000008:administration & dosage*; D015626:Tissue Expansion / Q000295:instrumentation* / Q000379:methods; D015625:Tissue Expansion Devices; D055815:Young Adult
chemical_list: D002245:Carbon Dioxide; D012965:Sodium Chloride