Clinical Outcomes of Acellular Dermal Matrix (SimpliDerm and AlloDerm Ready-to-Use) in Immediate Breast Reconstruction.

Background The use of acellular dermal matrix (ADM) for post-mastectomy reconstruction is considered by many surgeons to be an accepted component of surgical technique. Early clinical experience is described for SimpliDerm® - a novel human ADM (Aziyo Biologics, Silver Spring, USA), and AlloDerm® Ready-To-Use (RTU) - an established ADM (Allergan Medical, Irvine, USA). Methods Records were retrospectively reviewed from four sites between 2016 and 2021 of patients who underwent immediate, two-stage reconstruction with either SimpliDerm (n=38) or AlloDerm RTU (n=69) after mastectomy and were followed out to exchange to permanent implant(s), tissue expander(s) explant, or death. Results Immediate breast reconstruction with tissue expanders and ADM was performed on 107 patients (181 breasts). Overall mean patient age was 51.4 ± 12.4 years, and mean BMI was 28.0 ± 5.8 kg/m2. Significantly more patients in the SimpliDerm group were of Hispanic or Latino ethnicity (34.2% vs. 7.2%; P<.001). Reconstructions were predominantly prepectoral (82.3%). A total of 35 adverse events (AEs) occurred in 27 (25.2%) patients, with no difference in AE type, classification, or rates between ADM groups. No AEs were considered related to either ADM. The observed AE profiles and rates are similar to those published for other ADMs in immediate breast reconstruction. Conclusions There continues to be a need for additional clinically equivalent ADMs to provide physicians with more availability and options for their practice. This retrospective, multisite study describes comparable clinical outcomes with SimpliDerm and AlloDerm RTU through a median of 133.5 days (~four months) following immediate two-stage breast reconstruction.

The NetSage measurement and analysis framework in practice.

Data sharing is required for research collaborations, but effective data transfer performance continues to be difficult to achieve. The NetSage Measurement and Analysis Framework can assist in understanding research data movement. It collects a broad set of monitoring data and builds performance Dashboards to visualize the data. Each Dashboard is specifically designed to address a well-defined analysis need of the stakeholders. This paper describes the design methodology, the resulting architecture, the development approach and lessons learned, and a set of discoveries that NetSage Dashboards made possible.

Comparison of 30-day Clinical Outcomes with SimpliDerm and AlloDerm RTU in Immediate Breast Reconstruction.

BACKGROUND: Acellular dermal matrix (ADM) is widely used in breast reconstruction, and outcomes of these procedures may be improved through optimized product design. SimpliDerm is a new human ADM designed to closely preserve the architecture of native dermis, with the goal of improving surgical outcomes. This study reports the initial (30-day) clinical experience with SimpliDerm compared with AlloDerm Ready-To-Use (RTU) in ADM-assisted breast reconstruction. METHODS: Clinical characteristics and outcomes of 59 consecutive patients who underwent immediate 2-stage reconstruction with SimpliDerm (n = 28) or AlloDerm RTU (n = 31) following mastectomy are reported. RESULTS: Fifty-nine women (108 breasts) underwent posmastectomy breast reconstruction with SimpliDerm or AlloDerm RTU. Mean patient age was 51.1 years, and mean body mass index was 28.2 kg/m2. Reconstructions were predominantly prepectoral (95.4%), used tissue expanders (100%), and followed a skin-sparing (64%) approach to mastectomy. Mean time to final drain removal did not differ between groups (17.0 days, SimpliDerm versus 17.7 days, AlloDerm RTU). Adverse events occurred in 13 (22%) patients; none considered serious-all were mild or moderate in intensity. Adverse event rates did not differ between groups. The observed adverse event profiles and rates are similar to those published for other ADMs in immediate breast reconstruction. CONCLUSIONS: There remains a clinical need for ADMs with more optimal characteristics. This case series describes comparable outcomes with SimpliDerm and AlloDerm RTU over 30 days after immediate 2-stage breast reconstruction.

The medical science DMZ: a network design pattern for data-intensive medical science.

OBJECTIVE: We describe a detailed solution for maintaining high-capacity, data-intensive network flows (eg, 10, 40, 100 Gbps+) in a scientific, medical context while still adhering to security and privacy laws and regulations. MATERIALS AND METHODS: High-end networking, packet-filter firewalls, network intrusion-detection systems. RESULTS: We describe a "Medical Science DMZ" concept as an option for secure, high-volume transport of large, sensitive datasets between research institutions over national research networks, and give 3 detailed descriptions of implemented Medical Science DMZs. DISCUSSION: The exponentially increasing amounts of "omics" data, high-quality imaging, and other rapidly growing clinical datasets have resulted in the rise of biomedical research "Big Data." The storage, analysis, and network resources required to process these data and integrate them into patient diagnoses and treatments have grown to scales that strain the capabilities of academic health centers. Some data are not generated locally and cannot be sustained locally, and shared data repositories such as those provided by the National Library of Medicine, the National Cancer Institute, and international partners such as the European Bioinformatics Institute are rapidly growing. The ability to store and compute using these data must therefore be addressed by a combination of local, national, and industry resources that exchange large datasets. Maintaining data-intensive flows that comply with the Health Insurance Portability and Accountability Act (HIPAA) and other regulations presents a new challenge for biomedical research. We describe a strategy that marries performance and security by borrowing from and redefining the concept of a Science DMZ, a framework that is used in physical sciences and engineering research to manage high-capacity data flows. CONCLUSION: By implementing a Medical Science DMZ architecture, biomedical researchers can leverage the scale provided by high-performance computer and cloud storage facilities and national high-speed research networks while preserving privacy and meeting regulatory requirements.

The Medical Science DMZ.

OBJECTIVE: We describe use cases and an institutional reference architecture for maintaining high-capacity, data-intensive network flows (e.g., 10, 40, 100 Gbps+) in a scientific, medical context while still adhering to security and privacy laws and regulations. MATERIALS AND METHODS: High-end networking, packet filter firewalls, network intrusion detection systems. RESULTS: We describe a "Medical Science DMZ" concept as an option for secure, high-volume transport of large, sensitive data sets between research institutions over national research networks. DISCUSSION: The exponentially increasing amounts of "omics" data, the rapid increase of high-quality imaging, and other rapidly growing clinical data sets have resulted in the rise of biomedical research "big data." The storage, analysis, and network resources required to process these data and integrate them into patient diagnoses and treatments have grown to scales that strain the capabilities of academic health centers. Some data are not generated locally and cannot be sustained locally, and shared data repositories such as those provided by the National Library of Medicine, the National Cancer Institute, and international partners such as the European Bioinformatics Institute are rapidly growing. The ability to store and compute using these data must therefore be addressed by a combination of local, national, and industry resources that exchange large data sets. Maintaining data-intensive flows that comply with HIPAA and other regulations presents a new challenge for biomedical research. Recognizing this, we describe a strategy that marries performance and security by borrowing from and redefining the concept of a "Science DMZ"-a framework that is used in physical sciences and engineering research to manage high-capacity data flows. CONCLUSION: By implementing a Medical Science DMZ architecture, biomedical researchers can leverage the scale provided by high-performance computer and cloud storage facilities and national high-speed research networks while preserving privacy and meeting regulatory requirements.

Biologic collagen cylinder with skate flap technique for nipple reconstruction.

A surgical technique using local tissue skate flaps combined with cylinders made from a naturally derived biomaterial has been used effectively for nipple reconstruction. A retrospective review of patients who underwent nipple reconstruction using this technique was performed. Comorbidities and type of breast reconstruction were collected. Outcome evaluation included complications, surgical revisions, and nipple projection. There were 115 skate flap reconstructions performed in 83 patients between July 2009 and January 2013. Patients ranged from 32 to 73 years old. Average body mass index was 28.0. The most common comorbidities were hypertension (39.8%) and smoking (16.9%). After breast reconstruction, 68.7% of the patients underwent chemotherapy and 20.5% underwent radiation. Seventy-one patients had immediate breast reconstruction with expanders and 12 had delayed reconstruction. The only reported complications were extrusions (3.5%). Six nipples (5.2%) in 5 patients required surgical revision due to loss of projection; two patients had minor loss of projection but did not require surgical revision. Nipple projection at time of surgery ranged from 6 to 7 mm and average projection at 6 months was 3-5 mm. A surgical technique for nipple reconstruction using a skate flap with a graft material is described. Complications are infrequent and short-term projection measurements are encouraging.