• Rieky E G Dikmans, Vera L Negenborn, Mark-Bram Bouman, Hay A H Winters, Jos W R Twisk, P Quinten Ruhé, Marc A M Mureau, Jan Maerten Smit, Stefania Tuinder, Yassir Eltahir, Nicole A Posch, Josephina M van Steveninck-Barends, Marleen A Meesters-Caberg, René R W J van der Hulst, Marco J P F Ritt, and Margriet G Mullender.
• Department of Plastic, Reconstructive, and Hand Surgery, VU University Medical Centre, Amsterdam, Netherlands; EMGO Institute for Health and Care Research Amsterdam, Amsterdam, Netherlands.
• Lancet Oncol. 2017 Feb 1; 18 (2): 251-258.

BackgroundThe evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR.MethodsWe did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446.Findings142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups.InterpretationImmediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved.FundingPink Ribbon, Nuts-Ohra, and LifeCell.Copyright © 2017 Elsevier Ltd. All rights reserved.

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