Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial

“…The BRIOS study was an open‐label phase IV multicentre RCT that compared DTI breast reconstruction combined with ADM and a conventional two‐stage expander/implant breast reconstruction (without ADM)10. The early postoperative complication rate was significantly higher in the DTI ADM‐assisted group than the two‐stage group (38·5 versus 14·1 per cent; odds ratio (OR) 3·81; P  < 0·001).…”

Acellular dermal matrices safety in breast reconstruction—Is it truly associated with higher rates of complications? A large single‐surgeon cohort analysis

“…10 A randomized controlled trial including 92 reconstructions had very low rates of infection (2%) and skin necrosis (1%). 11 The present study benefits from its single-surgeon We conclude that future studies should include a minimum workload/surgeon/year or provide this information. This is of utmost importance given the unacceptably high complication rates reported in the literature, which may result in oncologic treatment delay with impact on disease outcome.…”

“…These rates are in accordance with previous series involving experienced surgeons, which reported 2.6% epidermolysis rates and 1.3% full skin flap necrosis, results mirrored by another study with a workload of 30 reconstructions/surgeon/year . A randomized controlled trial including 92 reconstructions had very low rates of infection (2%) and skin necrosis (1%) . The present study benefits from its single‐surgeon design, eliminating variability in surgical technique and allowing workload quantification.…”

Does the addition of mesh improve outcomes in implant based breast reconstruction after mastectomy for breast cancer?

“…Few studies have assessed health related quality of life or cosmetic outcomes 10. A randomised controlled trial11 (142 patients) reported a higher rate of surgical complications including reconstructive failure and the need for re-operation at one year in patients undergoing mesh assisted IBBR compared with traditional IBBR. This is a small study, however, and at high risk of bias because of lack of blinding of outcome assessors.…”

“…Since the completion of these reviews, a multicentre Dutch randomised controlled study (142 women) comparing single stage direct-to-implant IBBR with acellular dermal matrix and traditional two stage expander-implant reconstruction has reported11 safety data at one year (table 1). Patients in the acellular dermal matrix group experienced more surgical complications (odds ratio 3.46, 95% confidence interval 1.39 to 8.61), complications requiring re-operation (odds ratio 3.69, 95% confidence interval 1.31 to 10.42), and had a higher incidence of reconstructive failure (odds ratio 16.82, 95% confidence interval 2.44 to 115.94) than those undergoing traditional reconstruction.…”