The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction

Abstract

BackgroundThe 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/designsThe 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.DiscussionThere 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.Trial registrationClinicalTrials.gov: NCT00956384

The BREASTrial Stage II: ADM Breast Reconstruction Outcomes from Definitive Reconstruction to 3 Months Postoperative

“…Proponents to this approach have noted it to be cost-effective, to be safe, and to have a reasonable complication profile. 14 – 16 A current ongoing randomized trial comparing BREAST-Q and other outcomes between single-stage and 2-stage ADM breast reconstruction 17 should provide additional high level of evidence data to the current ADM breast reconstruction literature. Another area of recent interest in the literature is the use of terminally sterile ADMs, which may help mitigate the higher complication rates that ADM confers on breast reconstruction.…”

Quality of life and aesthetic results after mastectomy and mammary reconstruction

“…It is interesting to highlight the positive responses to the questions in the physical well-being domain, as more physical symptom complaints were expected after the surgical procedure. In 2013, Eltahir et al 30 . assessed the quality of life of women following breast reconstruction in comparison with those of patients who underwent mastectomy, using the BREAST-Q ® questionnaire, and observed that women showed less pain and fewer limitations after reconstruction (p = 0.007).…”

One-stage and two-stage breast reconstruction have no meaningful difference in patient quality of life

“…Out of the few relevant articles, the Zhong et al study is an ongoing protocol with no established results 18 , while another article by Dikmans et al studied one-stage vs. two-stage approaches but did not use quality of life as a primary endpoint 19 . The only suitable randomized controlled trial (RCT) selected for critical appraisal, entitled "Quality of life and patient satisfaction after one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage breast reconstruction (BRIOS): primary outcome of a randomised, controlled trial" 20 , studies the clinical question of interest and also uses quality of life as a primary endpoint.…”