title: The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction.
abstract: BACKGROUND
  The two-stage tissue expander/implant (TE/I) reconstruction is currently the gold standard method of implant-based immediate breast reconstruction in North America. Recently, however, there have been numerous case series describing the use of one-stage direct to implant reconstruction with the aid of acellular dermal matrix (ADM). In order to rigorously investigate the novel application of ADM in one-stage implant reconstruction, we are currently conducting a multicentre randomized controlled trial (RCT) designed to evaluate the impact on patient satisfaction and quality of life (QOL) compared to the two-stage TE/I technique.
  
  
  METHODS
  The MCCAT study is a multicenter Canadian ADM trial designed as a two-arm parallel superiority trial that will compare ADM-facilitated one-stage implant reconstruction compared to two-stage TE/I reconstruction following skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) at 2 weeks, 6 months, and 12 months. The source population will be members of the mastectomy cohort with stage T0 to TII disease, proficient in English, over the age of 18 years, and planning to undergo SSM or NSM with immediate implant breast reconstruction. Stratified randomization will maintain a balanced distribution of important prognostic factors (study site and unilateral versus bilateral procedures). The primary outcome is patient satisfaction and QOL as measured by the validated and procedure-specific BREAST-Q. Secondary outcomes include short- and long-term complications, long-term aesthetic outcomes using five standardized photographs graded by three independent blinded observers, and a cost effectiveness analysis.
  
  
  CONCLUSIONS
  There is tremendous interest in using ADM in implant breast reconstruction, particularly in the setting of one-stage direct to implant reconstruction where it was previously not possible without the intermediary use of a temporary tissue expander (TE). This unique advantage has led many patients and surgeons alike to believe that one-stage ADM-assisted implant reconstruction should be the procedure of choice and should be offered to patients as the first-line treatment. We argue that it is crucial that this technique be scientifically evaluated in terms of patient selection, surgical technique, complications, aesthetic outcomes, cost-effectiveness, and most importantly patient-reported outcomes before it is promoted as the new gold standard in implant-based breast reconstruction.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00956384.
authors.affiliation: Division of Plastic & Reconstructive Surgery, University Health Network, Toronto, ON, Canada. toni.zhong@uhn.ca.
authors.forename: Toni
authors.initials: T
authors.lastname: Zhong
authors.forename: Claire
authors.initials: C
authors.lastname: Temple-Oberle
authors.forename: Stefan O P
authors.initials: SO
authors.lastname: Hofer
authors.forename: Stefan
authors.initials: S
authors.lastname: Hofer
authors.forename: Brett
authors.initials: B
authors.lastname: Beber
authors.forename: John
authors.initials: J
authors.lastname: Semple
authors.forename: Mitchell
authors.initials: M
authors.lastname: Brown
authors.forename: Sheina
authors.initials: S
authors.lastname: Macadam
authors.forename: Peter
authors.initials: P
authors.lastname: Lennox
authors.forename: Tony
authors.initials: T
authors.lastname: Panzarella
authors.forename: Colleen
authors.initials: C
authors.lastname: McCarthy
authors.forename: Nancy
authors.initials: N
authors.lastname: Baxter
mesh_terms: D062088:Acellular Dermis / Q000191:economics; D019928:Breast Implantation / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D018427:Breast Implants / Q000191:economics; D001943:Breast Neoplasms / Q000191:economics / Q000473:pathology / Q000601:surgery*; D002170:Canada; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008408:Mastectomy; D009367:Neoplasm Staging; D017060:Patient Satisfaction; D011474:Prosthesis Design; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D015625:Tissue Expansion Devices; D016896:Treatment Outcome