An immunologically active, adipose-derived extracellular matrix biomaterial for soft tissue reconstruction: concept to clinical trial.

Soft tissue reconstruction remains an intractable clinical challenge as current surgical options and synthetic implants may produce inadequate outcomes. Soft tissue deficits may be surgically reconstructed using autologous adipose tissue, but these procedures can lead to donor site morbidity, require multiple procedures, and have highly variable outcomes. To address this clinical need, we developed an "off-the-shelf" adipose extracellular matrix (ECM) biomaterial from allograft human tissue (Acellular Adipose Tissue, AAT). We applied physical and chemical processing methods to remove lipids and create an injectable matrix that mimicked the properties of lipoaspirate. Biological activity was assessed using cell migration and adipogenesis assays. Characterization of regenerative immune properties in a murine muscle injury model revealed that allograft and xenograft AAT induced pro-regenerative CD4+ T cells and macrophages with xenograft AAT additionally attracting eosinophils secreting interleukin 4 (Il4). In immunocompromised mice, AAT injections retained similar volumes as human fat grafts but lacked cysts and calcifications seen in the fat grafts. The combination of AAT with human adipose-derived stem cells (ASCs) resulted in lower implant volumes. However, tissue remodeling and adipogenesis increased significantly in combination with ASCs. Larger injected volumes of porcine-derived AAT demonstrated biocompatibility and greater retention when applied allogeneicly in Yorkshire cross pigs. AAT was implanted in healthy volunteers in abdominal tissue that was later removed by elective procedures. AAT implants were well tolerated in all human subjects. Implants removed between 1 and 18 weeks demonstrated increasing cellular infiltration and immune populations, suggesting continued tissue remodeling and the potential for long-term tissue replacement.

Establishing a Culture of Patient Safety, Quality, and Service in Plastic Surgery: Integrating the Fractal Model.

PROBLEM: There are obstacles to effective nationwide implementation of a culture of patient safety. Plastic surgery faces unique challenges in this area because quality measures are not as well-established as in other fields. Plastic surgery may also require emphasis on patient-reported outcomes as a quality-of-life specialty with distinct concomitant analytical methods. APPROACH: We devised a dynamic framework, based on our 3-year experience using a Comprehensive Unit-Based Safety Program-a formal quality improvement committee structure, literature review, and work from The Johns Hopkins Armstrong Institute for Patient Safety and Quality. This framework is specific and exportable to the field of plastic surgery. Monthly patient safety, quality, and service committee meetings encourage multilevel participation in a bottom-up fashion, while connecting with other departments and entities in Johns Hopkins Medicine. Our model focuses our work in the following four domains: (1) safety, (2) external measures, (3) patient experience, and (4) value. Our framework identifies and communicates clear goals, creates necessary infrastructure, identifies opportunities and needs, uses robust performance to develop and implement interventions, and includes analytics to track improvement plans and results. OUTCOMES: We have gradually implemented this quality improvement structure into the Johns Hopkins Department of Plastic and Reconstructive Surgery successfully since 2012. Outcomes have improved in externally reported measures of patient safety, quality, and service. We have demonstrated exemplary National Surgical Quality Improvement Program performance for morbidity, return to operating room, and readmission rates. Patient satisfaction surveys show improvement related to the high-level patient experience.

The Use of Tumescent Technique in Mastectomy and Related Complications: A Meta-Analysis.

BACKGROUND: Postoperative skin necrosis in surgical patients is costly to hospitals and health care providers. Tumescent dissection technique is commonly used in mastectomy and immediate breast reconstruction, as it helps reduce blood loss; however, it may increase the risk of mastectomy skin flap necrosis. In this context, the authors have conducted a systematic review of the literature to perform a meta-analysis of the relationship between tumescent technique in mastectomy with or without breast reconstruction and complication rates. METHODS: The authors screened the PubMed (1966 to 2016), Scopus (2004 to 2016), Embase (1966 to 2016), and Web of Science (1964 to 2016) databases for relevant articles through March 30, 2017. The authors included studies on the use of tumescent technique in the context of mastectomy with or without immediate breast reconstruction. The primary outcome the authors evaluated was the rate of skin flap necrosis; the secondary outcomes were the rates of breast hematomas and infections. Because of the heterogeneity of the studies, the authors performed a meta-analysis using the random effects model. RESULTS: After screening, the authors evaluated five studies including 3982 mastectomies. Mastectomies performed under the preoperative application of tumescent solution had statistically higher rates of skin flap necrosis overall (p = 0.03) and major (p < 0.01) and minor skin necrosis (p = 0.03). However, the rates of hematoma and infection were not correlated with the use of tumescent technique. CONCLUSIONS: The authors' systematic review of the literature provides a better understanding of the consequences of the application of tumescent technique in mastectomy. The authors' findings suggest that tumescent technique may increase the risk of skin necrosis in mastectomy with or without breast reconstruction.

Prepectoral Versus Subpectoral Tissue Expander Placement: A Clinical and Quality of Life Outcomes Study.

BACKGROUND: Traditionally, tissue expanders (TEs) for breast reconstruction have been placed beneath the pectoralis major muscle with or without acellular dermal matrix. More recently, full acellular dermal matrix coverage has been described for prepectoral TE placement. Our study aims to explore differences in clinical and quality-of-life (QOL) outcomes for prepectoral versus subpectoral TE breast reconstruction. METHODS: We identified patients who underwent postmastectomy breast reconstruction with prepectoral or subpectoral TE placement between 2011 and 2015 and completed QOL surveys. Primary outcomes were postoperative pain and QOL scores. Secondary outcomes were clinical outcomes. We used Wilcoxon rank-sum test, chi-square test, and linear regression to compare outcomes. Postoperative follow-up for each patient was at least 60 days, except that of pain scores, which were at least 30 days. Mean age was 49 ± 10 years. RESULTS: Twenty-six prepectoral TE patients and 109 subpectoral TE patients met inclusion criteria. Pain scores were significantly lower at 12 hours, 1 day, 7 days, and 30 days postoperatively for the prepectoral group, compared with the subpectoral group, even after adjusting for confounding variables [PO12H: Sub-Pectoral (SP) median (interquartile range), 7 (5-8), Pre-Pectoral (PP), 5 (2.5-7.5), P value = 0.004; PO1D: SP, 5 (4-6), PP 3 (2-4), P value = < 0.001; PO7D: SP, 2 (0-4), PP, 0 (0-2), P value = 0.004; PO30D: SP, 0 (0-2), PP, 0 (0-0), P value = 0.039)]. Breast-Q scores were not significantly different between study groups. RAND-36 Physical Health scores were lower among prepectoral TE patients. CONCLUSIONS: Prepectoral TE breast reconstruction presents an opportunity to improve upon current reconstructive methods and does result in significantly lower pain scores. The associated risks have yet to be fully described and are important considerations, as these prepectoral patients had lower physical health outcome scores.

The Ethics of Hand Transplantation: A Systematic Review.

PURPOSE: We conducted a systematic review to document ethical concerns regarding human upper extremity (UE) allotransplantation and how these concerns have changed over time. METHODS: We performed a systematic review of 5 databases to find manuscripts addressing ethical concerns related to UE allotransplantation. Inclusion criteria were papers that were on the topic of UE allotransplantation, and related ethical concerns, written in English. We extracted and categorized ethical themes under the 4 principles of bioethics: Autonomy, Beneficence, Nonmaleficence, and Justice. We assessed theme frequency by publication year using Joinpoint regression, analyzing temporal trends, and estimating annual percent change. RESULTS: We identified 474 citations; 49 articles were included in the final analysis. Publication years were 1998 to 2015 (mean, 3 publications/y; range, 0-7 publications/y). Nonmaleficence was most often addressed (46 of 49 papers; 94%) followed by autonomy (36 of 49; 74%), beneficence (35 of 49; 71%), and justice (31 of 49; 63%). Of the 14 most common themes, only "Need for More Research/Data" (nonmaleficence) demonstrated a significant increase from 1998 to 2002. CONCLUSIONS: Upper extremity transplantation is an appealing reconstructive option for patients and physicians. Its life-enhancing (vs life-saving) nature and requirement for long-term immunosuppression have generated much ethical debate. Availability of human data has influenced ethical concerns over time. Our results indicate that discussion of ethical issues in the literature increased following publication of UE transplants and outcomes as well as after meetings of national societies and policy decisions by regulatory agencies. CLINICAL RELEVANCE: Because UE transplantation is not a life-saving procedure, much ethical debate has accompanied its evolution. It is important for UE surgeons considering referring patients for evaluation to be aware of this discussion to fully educate patients and help them make informed treatment decisions.