Rieky E G Dikmans1, Vera L Negenborn1, Mark-Bram Bouman2, Hay A H Winters2, Jos W R Twisk3, P Quinten Ruhé4, Marc A M Mureau5, Jan Maerten Smit6, Stefania Tuinder7, Yassir Eltahir8, Nicole A Posch9, Josephina M van Steveninck-Barends9, Marleen A Meesters-Caberg10, René R W J van der Hulst7, Marco J P F Ritt11, Margriet G Mullender12. 1. Department of Plastic, Reconstructive, and Hand Surgery, VU University Medical Centre, Amsterdam, Netherlands; EMGO Institute for Health and Care Research Amsterdam, Amsterdam, Netherlands. 2. Department of Plastic, Reconstructive, and Hand Surgery, VU University Medical Centre, Amsterdam, Netherlands; EMGO Institute for Health and Care Research Amsterdam, Amsterdam, Netherlands; Alexander Monro Breast Cancer Hospital, Bilthoven, Netherlands. 3. Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, Netherlands. 4. Department of Plastic, Reconstructive, and Hand Surgery, Meander Medical Centre, Amersfoort, Netherlands. 5. Department of Plastic, Reconstructive, and Hand Surgery, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Rotterdam, Netherlands. 6. Department of Plastic, Reconstructive, and Hand Surgery, VU University Medical Centre, Amsterdam, Netherlands; Alexander Monro Breast Cancer Hospital, Bilthoven, Netherlands. 7. Department of Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre, Maastricht, Netherlands. 8. Department of Plastic, Reconstructive, and Hand Surgery, University Medical Centre Groningen, Groningen, Netherlands. 9. Department of Plastic, Reconstructive, and Hand Surgery, Haga Ziekenhuis, Den Haag, Netherlands. 10. Department of Plastic, Reconstructive, and Hand Surgery, Orbis Medisch Centrum, Sittard, Netherlands. 11. Department of Plastic, Reconstructive, and Hand Surgery, VU University Medical Centre, Amsterdam, Netherlands. 12. Department of Plastic, Reconstructive, and Hand Surgery, VU University Medical Centre, Amsterdam, Netherlands; EMGO Institute for Health and Care Research Amsterdam, Amsterdam, Netherlands. Electronic address: m.mullender@vumc.nl.
Abstract
BACKGROUND: The 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. METHODS: We 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. FINDINGS:142 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. INTERPRETATION: Immediate 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. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.
RCT Entities:
BACKGROUND: The 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. METHODS: We 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. FINDINGS: 142 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. INTERPRETATION: Immediate 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. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.
Authors: Danny A Young-Afat; Christopher Gibbons; Anne F Klassen; Andrew J Vickers; Stefan J Cano; Andrea L Pusic Journal: Plast Reconstr Surg Date: 2019-03 Impact factor: 4.730
Authors: V L Negenborn; R E G Dikmans; M B Bouman; H A H Winters; J W R Twisk; P Q Ruhé; M A M Mureau; J M Smit; S Tuinder; J Hommes; Y Eltahir; N A S Posch; J M van Steveninck-Barends; M A Meesters-Caberg; R R W J van der Hulst; M J P F Ritt; M G Mullender Journal: Br J Surg Date: 2018-04-16 Impact factor: 6.939
Authors: Senthurun Mylvaganam; Elizabeth Conroy; Paula R Williamson; Nicola L P Barnes; Ramsey I Cutress; Matthew D Gardiner; Abhilash Jain; Joanna M Skillman; Steven Thrush; Lisa J Whisker; Jane M Blazeby; Shelley Potter; Christopher Holcombe Journal: Breast Date: 2017-07-30 Impact factor: 4.380
Authors: Vera L Negenborn; Rieky E G Dikmans; Mark-Bram Bouman; Janneke A Wilschut; Margriet G Mullender; C Andrew Salzberg Journal: Plast Reconstr Surg Glob Open Date: 2018-02-08