Acellular dermal matrices (ADMs) are broadly utilized as an adjunct to prosthetic breast reconstruction. They offer soft-tissue support to maintain the lateral and inframammary folds and can facilitate a match of the dimensions of the periprosthetic lamella with the mastectomy skin flap envelope.1 , 2 ADMs are distinguished from one another by their clinical performance, traditionally measured by complication rates, and by their cost, a factor that will become even more critical with bundled payment models on the horizon.3–7 The cost of using an ADM not only includes its price and impact on expensive reconstructive failures but also its potential for limiting the number of downstream reconstructive interventions.3 , 4 , 8 , 9 Increased initial cost of one product over another may be justifiable if it increases overall value-based care by improving outcomes and/or limiting future procedures.9
Although a large body of evidence exists evaluating the safety and complication rates associated with ADM-assisted prosthetic breast reconstruction, there is a surprising dearth of high quality (level 1 or level 2 evidence) studies, including prospective randomized controlled trials (RCTs), on the topic. This is a significant limitation that diminishes the utility of recent meta-analyses on ADM use in prosthetic breast reconstruction and prevents clinicians from effectively interpreting the results of these studies without the presence of bias inherent in retrospective study designs.10–12 The BREAST trial, the first RCT to compare ADMs in submuscular breast reconstruction, showed that overall complication and implant loss rates with freeze-dried AlloDerm were comparable with DermaMatrix using a noninferiority design.13–15 A subsequent RCT comparing ADM slings in submuscular reconstructions failed to demonstrate significant differences in outcomes between AlloDerm RTU and AlloMax. This study, however, may have been underpowered as complications rates of 8% versus 26.1% were not found to be significantly different.16 To our knowledge, there are no published RCTs comparing ADMs to one another when used in prepectoral breast reconstruction, an increasingly popular technique for prosthetic reconstruction Given the lack of high-quality studies available, a significant need remains for carefully designed and adequately powered RCTs comparing outcomes between various ADMs in submuscular and prepectoral prosthetic breast reconstruction.
Cortiva is a Tutoplast-sterilized human ADM with similar vascular, collagen, and elastin remodeling characteristics when compared with AlloDerm on histological analyses.17 To date, there are limited studies comparing complication rates and outcomes between Cortiva ADM and AlloDerm ADM. The only existing studies have demonstrated similar complication rates; however, these are limited by their retrospective study design.18–21 In this study, we introduce a robust RCT study design to compare clinical and patient-reported outcomes between Cortiva ADM and AlloDerm RTU ADM when used as a sling to support tissue expanders placed in the submuscular location in one study arm, and prepectoral reconstructions with tissue expanders (TEs) or direct-to-implants (DTI) in a separate study arm. Furthermore, we present results from our interim analysis of the submuscular study arm.
We are conducting a prospective, single-blinded, randomized control trial comparing AlloDerm RTU (Allergan Medical, Irvine, Calif.) medium thickness (1.6 ± 0.4 mm) to Cortiva 1 mm (RTI Surgical, Alachua, Fla.) Allograft Dermis (1.0 ± 0.2 mm) in the practices of TMM and MMT. Patients undergoing submuscular breast reconstruction with a TE and 16 × 8 cm ADM sling consisting of either AlloDerm or Cortiva are compared in one study arm. Patients undergoing prepectoral breast reconstruction with either DTI or TE supported by a 20 × 16 cm ADM sheet are compared in a separate study arm. In both arms, randomized patients are allocated 1:1 to one ADM or the other. This study is approved by our institutional review board (201606168) and listed on clinicaltrials.gov (NCT02891759).
We began enrolling patients for submuscular reconstruction using an ADM sling in February 2017. We subsequently noted a significant shift to prepectoral reconstructions both nationally and in our own practices,22 , 23 and added the prepectoral arm to optimize enrollment rates and reflect our own pattern of practice. We determined that the perceived and reported differences between prepectoral and submuscular reconstructions like pain and animation deformity would be too profound,24 , 25 and create too much variability to be included in the same analysis and so parallel prepectoral and submuscular arms were initiated (Fig. 1).
Female patients, aged 22–70 years old, undergoing immediate prosthetic reconstruction following therapeutic or prophylactic skin- or nipple-sparing mastectomy with a body mass index (BMI) less than 36 kg/m2 are enrolled. We have excluded patients who are pregnant, breastfeeding immediately before mastectomy, unwilling to sign or unable to comprehend written informed consent. The decision to proceed with prepectoral or submuscular reconstruction with either a TE or DTI is determined preoperatively. Our consent process, however, maintains flexibility to choose the alternative plane for implant placement, and device type, if determined clinically appropriate by the plastic surgeon. In those instances, we would continue to use the ADM to which the patient was randomized (ie, if the patient was told they would most likely receive a prepectoral immediate implant and was randomized to a 20 × 16 cm AlloDerm RTU preoperatively, but was intraoperatively switched to a submuscular TE, then the patient would be switched to the submuscular study arm and would still receive AlloDerm RTU, but a 16 × 8 cm sheet instead).
Surgical Procedure for Submuscular Reconstruction with Acellular Dermal Matrix Sling
Submuscular reconstructions are performed immediately following a skin- or nipple-sparing mastectomy. The pectoralis major muscle is elevated by releasing its caudal attachments to create a submuscular pocket that accommodates a TE selected based on base width, mastectomy specimen weight, and patient goals. Using absorbable suture, through transverse incisions, the ADM is secured along the medial, lateral, and inframammary fold, the TE placed, and the caudal edge of the pectoralis sutured to the cephalad leading edge of the ADM. For lateral radial incisions, the ADM is secured medially and centrally, the TE placed, and ADM inset completed along the lateral mammary fold. For inframammary incisions, the ADM is secured to the caudal edge of the pectoralis and the medial and lateral mammary folds defined before the TE is placed and the ADM secured to define the inframammary fold.
Surgical Procedure for Prepectoral Reconstructions with Acellular Dermal Matrix
The ADM is manually fenestrated and tacked superiorly to define the upper pole of the reconstruction after which the medial and lateral mammary folds are defined by the ADM with absorbable, tacking sutures. DTIs are placed if the skin envelopes are deemed adequately perfused by clinical judgment occasionally supplemented with indocyanine green and laser-assisted imaging. In these cases, the ADM is draped over the implant with sufficient tension to minimize the risk of malrotation. Otherwise, a TE is placed, tabbed to avoid malposition, with additional lower pole laxity accounted for with the inset. The inframammary border of the ADM inset is placed last, with a gutter to reinforce the integrity of the lower pole when sufficient ADM is available.
Patients undergoing TE placement in either study arm are followed until exchange with an implant, flap, or both, or premature device removal for any reason. Patients undergoing DTI reconstruction are followed for at least 3 months postoperatively. Patients undergoing reoperation of the surgical site without device exchange or removal are kept in the study. Breast-level data are independently collected for bilateral cases so if one device is removed or exchanged prematurely, the patient remains in the study until the contralateral breast is removed or exchanged for TEs, or at least 3 months postoperatively for DTIs. Date of drain removal, which occurs once output drops below 30 cc for 24 hours, is prospectively recorded.
The primary outcome measure, analyzed at the breast-level, is premature explantation of the TE before exchange, or unintended explantation of a DTI reconstruction before 3 months. Secondary breast-level outcome measures include other complications like seroma, cellulitis, wound or ADM dehiscence, or skin flap necrosis. We record TE or DTI device size, absolute and relative and final TE fill volumes, time to drain removal, reason for premature explantation, and the type and timing of final reconstruction upon TE exchange. At the time of TE removal, the decision to proceed to an implant exchange versus a flap was based on surgeon and patient preference with a bias toward flaps in radiated patients. ADM integration is semiquantitatively assessed at the time of TE exchange or TE or DTI premature removal using a grading scale outlined in Table 5 categorized as 0%, <50%, 50–99%, and 100% ADM integration. Patient level data include antibiotic use and narcotic consumption postoperatively. Patient-reported outcomes are measured with the pre- and postoperative Breast-Q for all patients, and Qscore reported as an absolute value and ΔQscore for domains where pre- and postoperative values are generated.
Sample size determination was based on the primary hypothesis test for the incidence of premature TE or DTI removal. We assumed a premature TE or DTI removal rate of 20% as observed in one ADM group and 9% in the other ADM group in patients undergoing prepectoral reconstruction and in patients undergoing submuscular reconstruction, respectively. The hypothesized rates are based on published data from our group in >3,000 breasts who have undergone similar procedures.7 , 26–28 For this phase 2 randomized control trial, we require 180 eligible patients, per arm, to achieve 80% power based on the 1-sided Z test with pooled variance to detect a difference between the incidence rates of the 2 ADMs at a 0.1 significance level.29 We will separately compare the 2 ADMs among 180 patients receiving prepectoral and among 180 patients receiving submuscular reconstruction (Fig. 1).
For the final analysis, we will use logistic regression models to assess the effect of ADM type accounting for other confounding factors like obesity, age, radiation therapy, chemotherapy, lymph node surgery, surgery type, and cancer stage on the presence of complications. Variables that are significant (P ≤ 0.2) in univariate analysis and/or clinically relevant will be included in the multivariate logistic regression model.
Statistical analysis of Breast-Q data will be performed on 18 scales, derived from 6 modules of the Breast-Q for breast reconstruction.21 The Breast-Q is scored on a 0–100 points scale (0-dissatisfied, 100-maximally satisfied) using QScore, which has been developed according to the Rasch model.30 The Mann-Whitney U test will be used to detect the difference in data generated from evaluation of the Breast-Q, TE fills, drain use, and narcotic use between ADM types. The Gamma regression in the generalized linear model framework will be applied to model QScore with incorporation of other confounding factors.
Chi-square and the Fisher’s exact test were used in the interim analysis to detect the association between ADM type and TE or DTI removal incidence and between ADM type and complications. For the interim analysis, we use descriptive statistics to describe the central tendency and variation of 3 outcome variables—physical well-being, satisfaction with information, and satisfaction with plastic surgeon in each arm. Then, we used a 2-sample t test to compare the mean of each outcome between the 2 ADMs. We also used the nonparametric Wilcoxon rank-sum statistic to compare the median of each outcome between the 2 ADMs. Statistical analyses were performed in SAS (Version 9.4, SAS Institute, Cary, N.C.) while descriptive statistics were analyzed and graphed in Prism (Version 7.0 for MAC, GraphPad Software, La Jolla, Calif.).
Patient Demographics and Surgical Details
Thirty-four patients (Table 1), whose 59 breasts were reconstructed with AlloDerm RTU (n = 17 patients, n = 28 breasts) or Cortiva 1 mm (n = 17 patients, n = 31 breasts) submuscular TE, completed the interim analysis (Table 2). Nearly half of the reconstructions were for prophylactic mastectomy, and there with no statistically significant differences with respect to BMI, race, incidence of radiation therapy, nipple-sparing mastectomy, bilateral cases, or chemotherapy. The AlloDerm RTU group (Table 2) was comprised of a significantly higher proportion of patients who had never smoked (P = 0.009). Mastectomy specimen weight, initial TE fill volume, percentage of the TE initially filled, and final TE fill volume was not significantly different between groups. The initial size of the TE selected was significantly larger in patients reconstructed with Cortiva 1 mm (P = 0.02).
In most cases, the 10 French subpectoral drain was removed after the 15 French prepectoral drain, with removal of the final drain, regardless of size or location, occurring in 17.7 ± 7.0 days for AlloDerm RTU and 17.0 ± 7.6 days for Cortiva 1 mm. No significant differences were detected between cohorts (Table 3).
Complications are presented in Table 4. A clinically detectable seroma was identified in 10.7% (N = 3) of breasts reconstructed with AlloDerm RTU and 0% with Cortiva 1 mm. Premature explantation was performed in no (0.0%) breasts reconstructed with AlloDerm RTU and 1 breast (3.2%) reconstructed with Cortiva 1 mm. The breast associated with explantation was also the only one affected by postoperative cellulitis, initially treated with oral doxycycline followed by intravenous cefazolin before ultimate explantation.
Timing to Second-stage and ADM Integration
Patients underwent planned exchange of TEs for implants or flaps (Table 5) within 145.6 ± 51.6 days in the AlloDerm RTU and 167.0 ± 61.5 days in the Cortiva 1 mm cohorts (P = 0.27). The majority of patients were exchanged with a breast implant alone, but 14.3% in the AlloDerm RTU and 26.6% in the Cortiva 1 mm groups (P = 0.25) received an autologous flap (Table 5). Integration of the ADM to the mastectomy flap (Table 5), determined by our semiquantitative analysis, was robust in the majority of patients with no significant difference between groups (P = 0.69).
Narcotic Use and Patient-reported Outcomes
Most patients stopped using narcotics for pain control within 1 or 2 weeks of the mastectomy with immediate reconstruction (Fig. 2). There were no significant differences between the AlloDerm RTU and Cortiva 1 mm cohorts with respect to physical well-being, or satisfaction with information or plastic surgeon (Table 6).
Prosthetic breast reconstruction has benefited from the use of ADMs to provide soft-tissue support, maintain device position, and limit the manipulation of autologous tissues. Although abundant data support the use of ADMs,31–37 several recent meta-analyses confirm the need for additional level 1 and 2 evidence to establish how one ADM compares to another and how they are influenced by patient and therapeutic factors. There are a limited number of randomized control trials specifically comparing one ADM to another when providing support for submuscular reconstructions,13 , 14 , 16 and none, in the context of prepectoral reconstructions.
The original iteration of this trial excluded prepectoral breast reconstructions to minimize technique- versus ADM-associated variability. As our study progressed, however, we noted a growing percentage of reconstructive breast implants in our practice, and nationally, were being placed prepectoral. Early data on prepectoral reconstructions suggest that they are associated with less pain,25 less impact on range of motion,38 higher initial and subsequent rates of TE fill volumes,25 improved aesthetic outcomes,23 less capsular contracture following radiotherapy,39 , 40 and comparable complication rates to submuscular reconstruction.39 That said, the prospective studies with long-term follow-up required to further delineate the advantages and indications for prepectoral breast reconstructions are lacking.25 , 41–43 Therefore, expanding our study to specifically evaluate the performance of Cortiva versus AlloDerm RTU in prepectoral reconstruction has considerable value. Successful and sustainable prepectoral reconstruction may be even more reliant on the performance of one ADM over another. In addition to providing lateral and inframammary fold support, ADMs used for prepectoral reconstruction are relied upon to provide upper pole coverage, and are typically 2 to 2.5 times larger (increasing surface area that needs to incorporate) and more expensive.22 , 23 , 39 Recognizing the benefit of studying prepectoral reconstructions, but acknowledging the marked differences with submuscular reconstructions that would preclude inclusion into the same cohort, we have added a separate prepectoral study arm comparing AlloDerm RTU to Cortiva 1 mm.
We chose a prospective randomized control trial design to control for population bias, and the numerous covariates that impact the heterogeneous population of women seeking immediate prosthetic breast reconstruction. Nonetheless, randomized control trials may possess unidentified biases that characterize those patients willing to participate in them, and are subject to patients who are lost to follow-up. Further, a substantially higher powered study would make our findings more robust, and along with longer term follow-up would enable us to study the impact of these ADMs on capsular contracture rates. Interim analysis of the first 34 patients to complete the submuscular arm of our study identified no statistically significant findings clearly attributable to the ADM. Moreover, none of the postoperative patient-reported outcome metrics evaluated differed based on ADM (Table 6). Notably, the composition of our study population closely resembled that of another RCT, the BREASTrial,13 with some important exceptions. The BREASTtrial is skewed to a higher proportion of patients with stage III or greater cancers, radiation, and chemotherapy than our study (Tables 2 and 3). Our study, however, is comprised of a high percentage of smokers (Table 2), which reflects the general population.44 Compared with the BREASTrial, patients in our study had drains for a shorter period of time (~17 versus 21 days), with fewer explantations (0–3.3% versus 5 to 11.2%). Preliminary data from our RCT also compares favorably to retrospective data obtained from Keifer et al.18 that compares freeze-dried AlloDerm to Cortiva, albeit in a more heterogeneous population that included both TE and DTI reconstructions. The similar clinical performance metrics that we have identified between AlloDerm RTU and Cortiva may relate, in part, to similar-appearing ADM remodeling on gross examination. We found, using a semiquantitative assessment, no obvious differences in the degree of ADM integration at the time of TE exchange (Table 5). Upon histologic examination, Moyer et al.17 have also noted similar levels of elastin deposition and revascularization of AlloDerm and Cortiva following prosthetic breast reconstruction.
High-quality evidence is needed to compare the performance of various ADMs used in prosthetic breast reconstruction. Prepectoral reconstructions represent a unique population within prosthetic breast reconstruction and have several notable differences when compared with submuscular reconstructions. As such, trials comparing ADM performance should separate these patient cohorts to eliminate the potential bias that plane of prosthesis placement can have on outcome. In this study, we outline a protocol for a robust RCT to evaluate complications, clinical outcomes, and patient-reported outcomes in both submuscular and prepectoral prosthetic breast reconstruction assisted by 2 distinct types of ADM. Interim analysis of a limited sample of submuscular reconstructions reveals no evidence of inferiority of outcomes in a comparison of AlloDerm RTU to Cortiva.
The authors are grateful to RTI for funding this study. The authors are also grateful to Ms. Colleen Kilbourne-Glynn for administrative support for this study and Ms. Annette Irving for assistance with institutional review board preparation.
1. Jordan SW, Khavanin N, Fine NA, et al. An algorithmic approach for selective acellular dermal matrix use in immediate two-stage breast reconstruction: indications and outcomes. Plast Reconstr Surg. 2014;134:178–188.
2. Namnoum JD. Expander/implant reconstruction with AlloDerm: recent experience. Plast Reconstr Surg. 2009;124:387–394.
3. Qureshi AA, Broderick K, Funk S, et al. Direct hospital cost of outcome pathways in implant-based reconstruction with acellular dermal matrices. Plast Reconstr Surg Glob Open. 2016;4:e831.
4. Qureshi AA, Broderick KP, Belz J, et al. Uneventful versus successful reconstruction and outcome pathways in implant-based breast reconstruction with acellular dermal matrices. Plast Reconstr Surg. 2016;138:173e–183e.
5. Myckatyn T, Pierce A, Hall B. Discussion of cost-effectiveness analysis of silicone vs. saline implant-based breast reconstruction using the BREAST-Q. Plast Reconstr Surg. In Press.
6. Kanuri A, Song DH. Discussion: conceptual considerations for payment bundling in breast reconstruction. Plast Reconstr Surg. 2018;141:301–303.
7. Parikh RP, Brown G, Sharma K, et al. Immediate implant-based breast reconstruction with acellular dermal matrix: a comparison of sterile and aseptic AlloDerm in 2039 consecutive cases. Plast Reconstr Surg. In Press.
8. Krishnan NM, Chatterjee A, Rosenkranz KM, et al. The cost effectiveness of acellular dermal matrix in expander-implant immediate breast reconstruction. J Plast Reconstr Aesthet Surg. 2014;67:468–476.
9. Macadam SA, Lennox PA. Acellular dermal matrices: economic considerations in reconstructive and aesthetic breast surgery. Clin Plast Surg. 2012;39:187–216.
10. Lee KT, Mun GH. A meta-analysis of studies comparing outcomes of diverse acellular dermal matrices for implant-based breast reconstruction. Ann Plast Surg. 2017;79:115–123.
11. Sobti N, Liao EC. Surgeon-controlled study and meta-analysis comparing FlexHD and AlloDerm in immediate breast reconstruction outcomes. Plast Reconstr Surg. 2016;138:959–967.
12. Lee KT, Mun GH. Updated evidence of acellular dermal matrix use for implant-based breast reconstruction: a meta-analysis. Ann Surg Oncol. 2016;23:600–610.
13. Agarwal JP, Mendenhall SD, Anderson LA, et al. The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial. Plast Reconstr Surg. 2015;135:20e–28e.
14. Mendenhall SD, Anderson LA, Ying J, et al. The BREASTrial: stage I. Outcomes from the time of tissue expander and acellular dermal matrix placement to definitive reconstruction. Plast Reconstr Surg. 2015;135:29e–42e.
15. Mendenhall SD, Anderson LA, Ying J, et al. The BREASTrial stage II: ADM breast reconstruction outcomes from definitive reconstruction to 3 months postoperative. Plast Reconstr Surg Glob Open. 2017;5:e1209.
16. Hinchcliff KM, Orbay H, Busse BK, et al. Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: a prospective randomized trial. J Plast Reconstr Aesthet Surg. 2017;70:568–576.
17. Moyer HR, Hart AM, Yeager J, et al. A histological comparison of two human acellular dermal matrix products in prosthetic-based breast reconstruction. Plast Reconstr Surg Glob Open. 2017;5:e1576.
18. Keifer OP Jr, Page EK, Hart A, et al. A complication analysis of 2 acellular dermal matrices in prosthetic-based breast reconstruction. Plast Reconstr Surg Glob Open. 2016;4:e800.
19. Rundell VL, Beck RT, Wang CE, et al. Complication prevalence following use of tutoplast-derived human acellular dermal matrix in prosthetic breast reconstruction: a retrospective review of 203 patients. J Plast Reconstr Aesthet Surg. 2014;67:1345–1351.
20. Venturi ML, Mesbahi AN, Boehmler JH 4th, et al. Evaluating sterile human acellular dermal matrix in immediate expander-based breast reconstruction: a multicenter, prospective, cohort study. Plast Reconstr Surg. 2013;131:9e–18e.
21. Losken A. Early Results Using Sterilized Acellular Human Dermis (Neoform) in Post-Mastectomy Tissue Expander Breast Reconstruction. Plast Reconstr Surg. 2009;123:16541658.
22. Nahabedian MY, Glasberg SB, Maxwell GP. Introduction to “Prepectoral Breast Reconstruction”. Plast Reconstr Surg. 2017;140:4S–5S.
23. Ter Louw RP, Nahabedian MY. Prepectoral breast reconstruction. Plast Reconstr Surg. 2017;140(5S Advances in Breast Reconstruction):51S–59S.
24. Hammond DC, Schmitt WP, O’Connor EA. Treatment of breast animation deformity in implant-based reconstruction with pocket change to the subcutaneous position. Plast Reconstr Surg. 2015;135:1540–1544.
25. Zhu L, Mohan AT, Abdelsattar JM, et al. Comparison of subcutaneous versus submuscular expander placement in the first stage of immediate breast reconstruction. J Plast Reconstr Aesthet Surg. 2016;69:e77–e86.
26. Cohen JB, Carroll C, Tenenbaum MM, et al. Breast implant-associated infections: the role of the National Surgical Quality Improvement Program and the local microbiome. Plast Reconstr Surg. 2015;136:921–929.
27. Dolen UC, Schmidt AC, Um GT, et al. Impact of neoadjuvant and adjuvant chemotherapy on immediate tissue expander breast reconstruction. Ann Surg Oncol. 2016;23:2357–2366.
28. Qureshi AA, Broderick KP, Belz J, et al. Uneventful versus Successful Reconstruction and Outcome Pathways in Implant-Based Breast Reconstruction with Acellular Dermal Matrices. Plast Reconstr Surg. 2016;138:173e–183e.
29. Jung SH. Design of phase II non-inferiority trials. Contemp Clin Trials Commun. 2017;7:23–27.
30. Pusic AL, Klassen AF, Scott AM, et al. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009;124:345–353.
31. Weichman KE, Wilson SC, Saadeh PB, et al. Sterile “ready-to-use” AlloDerm decreases postoperative infectious complications in patients undergoing immediate implant-based breast reconstruction with acellular dermal matrix. Plast Reconstr Surg. 2013;132:725–736.
32. Weichman KE, Wilson SC, Weinstein AL, et al. The use of acellular dermal matrix in immediate two-stage tissue expander breast reconstruction. Plast Reconstr Surg. 2012;129:1049–1058.
33. Liu AS, Kao HK, Reish RG, et al. Postoperative complications in prosthesis-based breast reconstruction using acellular dermal matrix. Plast Reconstr Surg. 2011;127:1755–1762.
34. Liu DZ, Mathes DW, Neligan PC, et al. Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Ann Plast Surg. 2014;72:503–507.
35. Sbitany H, Langstein HN. Acellular dermal matrix in primary breast reconstruction. Aesthet Surg J. 2011;31:30S–37S.
36. Sbitany H, Sandeen SN, Amalfi AN, et al. Acellular dermis-assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009;124:1735–1740.
37. Sbitany H, Serletti JM. Acellular dermis-assisted prosthetic breast reconstruction: a systematic and critical review of efficacy and associated morbidity. Plast Reconstr Surg. 2011;128:1162–1169.
38. Vidya R, Masià J, Cawthorn S, et al. Evaluation of the effectiveness of the prepectoral breast reconstruction with Braxon dermal matrix: first multicenter European report on 100 cases. Breast J. 2017;23:670–676.
39. Nahabedian MY, Cocilovo C. Two-stage prosthetic breast reconstruction: a comparison between prepectoral and partial subpectoral techniques. Plast Reconstr Surg. 2017;140(6S Prepectoral Breast Reconstruction):22S–30S.
40. Sinnott CJ, Persing SM, Pronovost M, et al. Impact of postmastectomy radiation therapy in prepectoral versus subpectoral implant-based breast reconstruction. Ann Surg Oncol. 2018;25:2899–2908.
41. Dikmans RE, Negenborn VL, Bouman MB, et al. 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. Lancet Oncol. 2017;18:251–258.
42. Bernini M, Calabrese C, Cecconi L, et al. Subcutaneous direct-to-implant breast reconstruction: surgical, functional, and aesthetic results after long-term follow-up. Plast Reconstr Surg Glob Open. 2015;3:e574.
Copyright © 2018 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons. All rights reserved.
43. Sigalove S, Maxwell GP, Sigalove NM, et al. Prepectoral implant-based breast reconstruction: rationale, indications, and preliminary results. Plast Reconstr Surg. 2017;139:287–294.