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

Trials

Nancy Baxter²  Colleen McCarthy⁴  Tony Panzarella¹  Peter Lennox³  Sheina Macadam³  Mitchell Brown⁶  John Semple⁶  Brett Beber⁶  Stefan Hofer⁵  Claire Temple-Oberle⁷  Toni Zhong⁵ 

[1]Division of Biostatistics, University Health Network, Toronto, ON, Canada

[2]Department of Surgery, St. Michael’s Hospital, Toronto and the Keenan Research Centre, Toronto, Ontario, Canada

[3]Division of Plastic & Reconstructive Surgery, Vancouver General Hospital and the University of British Columbia, Vancouver, BC, Canada

[4]Plastic & Reconstructive Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

[5]Division of Plastic and Reconstructive Surgery, University of Toronto, Toronto, ON, Canada

[6]Plastic & Reconstructive Surgery, Women’s College Hospital, Toronto, ON, Canada

[7]Plastic Surgery Oncology, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada

关键词: Tissue expander;    One-stage;    Acellular dermal matrix;    Implant;    Breast reconstruction;   

Others  :  834754
DOI  :  10.1186/1745-6215-14-356

 received in 2013-04-29, accepted in 2013-10-01,  发布年份 2013

【 摘 要 】

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/designs

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.

Discussion

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.

Trial registration

ClinicalTrials.gov: NCT00956384

【 授权许可】

   
2013 Zhong et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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