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

ABSTRACT: 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.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.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.ClinicalTrials.gov: NCT00956384.

SUBMITTER: Zhong T

PROVIDER: S-EPMC3842809 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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

Zhong Toni T Temple-Oberle Claire C Hofer Stefan O P SO Beber Brett B Semple John J Brown Mitchell M Macadam Sheina S Lennox Peter P Panzarella Tony T McCarthy Colleen C Baxter Nancy N

Trials 20131028

<h4>Background</h4>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 rando ...[more]

PMID: 24165392

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Project description:BackgroundThe use of acellular dermal matrix (ADM) in one-stage immediate implant-based breast reconstruction (BR) may offer advantages over the two-stage expander-to-implant technique, but literature shows conflicting results. The aim of the present study was to compare these two techniques for immediate implant-based BR regarding postoperative complications, aesthetic correction procedures and aesthetic outcome.MethodsThe study was designed as an observational cohort study with 44 participants admitted for immediate implant-based BR at Department of Plastic Surgery, Aarhus University Hospital, Denmark. 21 patients underwent BR with a one-stage direct-to-implant technique using ADM and 23 patients underwent BR with a two-stage expander-to-implant technique. Follow-up time was 2 years.ResultsThe risk of implant loss was equal between groups; one-stage group 16% and two-stage group 17% whereas the risk of implant exchange (but not loss of BR) was 13% in the one-stage group compared to 7% in the two-stage group. The risk of at least one major complication were equal between groups; 28% and 24% but the risk of at least one minor complication was significantly higher in the two-stage group (41%) compared to the one-stage group (3%). Number of aesthetic corrections were equally frequent in the two treatment groups (one-stage group 1.8, two-stage group 1.5). Patient and investigator assessed aesthetic outcome was very high in both groups as well as the degree of symmetry between breasts. No capsular contracture Baker grade 3 or 4 was observed.ConclusionsThe present study design sets limitations for drawing wide conclusions. This study did not reveal any significant differences between the two breast reconstructive techniques besides a higher risk of minor complications in the two-stage group, that did, however, not lead to a higher risk of implant loss. With equally high satisfaction with the aesthetic result and no significant difference in number of aesthetic corrections between the two groups we suggest, that the one-stage approach using ADM may be feasible and allows the patient to achieve an implant-based BR with a minimum of surgeries and outpatient visits. The study was registered in ClinicalTrials.gov (NCT04209010).

Project description:ImportanceThe use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking.ObjectiveTo evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM.Design, setting, and participantsThis was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017.InterventionsParticipants were allocated to immediate IBBR with or without ADM.Main outcomes and measuresThe primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire.ResultsFrom start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11).Conclusions and relevanceImmediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits.Trial registrationClinicalTrials.gov Identifier: NCT02061527.

Dataset Information

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

Publications

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

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