One Step Double Augmentation with Human Dermis Allograft and Homologous PRP in Misdiagnosed and or Chronic Achilles Tendon Ruptures.

OBJECTIVE: Misdiagnosed/chronic Achilles tendon injuries are rare and disabling for patients. The surgical treatment of these rare injuries aims to ensure the tendon heals mechanically and biologically. This is the prerequisite for a good clinical and functional outcome and reduces recurrences. The main aim of the study is to present a surgical technique that has proven to be original, reproducible, and capable of guaranteeing solid tendon repair and optimal tissue regeneration. METHODS: We treated five patients, four males and one female, with the one-step double augmentation technique. All patients of this study complained of pain, but above all severe functional limitation that Achilles tendon injury had been causing for more than a month. In this study, we widely described the surgical technique, original and not found in the literature, which provides a biological graft (allograft of decellularized dermis) and homologous, thrombin-activated, platelet-rich plasma (H-PRP) in a single step. Surgical approach, always used by the first author, respected predefined steps: careful dissection and preparation of the peritendinous tissues from suture to the end of the procedure, tenorrhaphy, and augmentation with allopatch to obtain a mechanically effective repair to avoid recurrences, and finally "biological" augmentation with a unit of homologous, thrombin activated, PRP. We offered to all patients a regenerative rehabilitation program post-operatively. RESULTS: All patients were evaluated clinically (functional clinical tests and questionnaires) and instrumentally (elastic-sonography and perfusion MRI). The obtained results have been evaluated at a minimum follow-up of 18 months and a maximum of 24 months. In all patients pain was resolved, and district function and kinetic chains improved with resumption of daily activities, work, and sports. CONCLUSION: The present study confirmed the regenerative potential of decellularized dermis allograft and PRP (homologous and thrombin-activated). The same approach can also be exploited in cases of severe tendon destructuring and limited "intrinsic" regenerative potential at any age. The proposed one-step surgical technique of a double augmentation therefore appears useful, safe, reproducible, and applicable in all chronic tendon lesions with low regenerative potential.

Implementation of a patient blood management in an Italian City Hospital: is it effective in reducing the use of red blood cells?

To evaluate the effect of patient blood management (PBM) since its introduction, we analyzed the need for transfusion and the outcomes in patients undergoing abdominal surgery for different types of tumor pre- and post-PBM. Patients undergoing elective gastric, liver, pancreatic, and colorectal surgery between 2017 and 2020 were included. The implementation of the PBM program was completed on May 1, 2018. The patients were grouped as follows: those who underwent surgery before the implementation of the program (pre-PBM) versus after the implementation (post-PBM). A total of 1302 patients were included in the analysis (445 pre-PBM vs. 857 post-PBM). The number of transfused patients per year decreased significantly after the introduction of PBM. A strong tendency for a decreased incidence of transfusion was evident in gastric and pancreatic surgery and a similar decrease was statistically significant in liver surgery. With regard to gastric surgery, a single-unit transfusion scheme was used more frequently in the post-PBM group (7.7% vs. 55% after PBM; p = 0.049); this was similar in liver surgery (17.6% vs. 58.3% after PBM; p = 0.04). Within the subgroup of patients undergoing liver surgery, a significant reduction in the use of blood transfusion (20.5% vs. 6.7%; p = 0.002) and a decrease in the Hb trigger for transfusion (8.5, 8.2-9.5 vs. 8.2, 7.7-8.4 g/dl; p = 0.039) was reported after the PBM introduction. After the implementation of a PBM protocol, a significant reduction in the number of patients receiving blood transfusion was demonstrated, with a strong tendency to minimize the use of blood products for most types of oncologic surgery.

Stability Program in Dendritic Cell Vaccines: A "Real-World" Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center.

Advanced therapy medical products (ATMPs) are rapidly growing as innovative medicines for the treatment of several diseases. Hence, the role of quality analytical tests to ensure consistent product safety and quality has become highly relevant. Several clinical trials involving dendritic cell (DC)-based vaccines for cancer treatment are ongoing at our institute. The DC-based vaccine is prepared via CD14+ monocyte differentiation. A fresh dose of 10 million DCs is administered to the patient, while the remaining DCs are aliquoted, frozen, and stored in nitrogen vapor for subsequent treatment doses. To evaluate the maintenance of quality parameters and to establish a shelf life of frozen vaccine aliquots, a stability program was developed. Several parameters of the DC final product at 0, 6, 12, 18, and 24 months were evaluated. Our results reveal that after 24 months of storage in nitrogen vapor, the cell viability is in a range between 82% and 99%, the expression of maturation markers remains inside the criteria for batch release, the sterility tests are compliant, and the cell costimulatory capacity unchanged. Thus, the data collected demonstrate that freezing and thawing do not perturb the DC vaccine product maintaining over time its functional and quality characteristics.

ERICA: A multiparametric toxicological risk index for the assessment of environmental healthiness.

A risk assessment strategy considering the impact of chemicals on the whole ecosystem has been developed in order to create a sound and useful method for quantifying and comparing the global risk posed by the main different hazardous chemicals found in the environment. This index, called Environmental Risk Index for Chemical Assessment (ERICA), merges in a single number the environmental assessment, the human health risk assessment and the uncertainty due to missing or uncertain data. ERICA uses a dedicated scoring system with parameters for the main characteristics of the pollutants. The main advantage is that it preserves a simple approach by condensing in this single value an analysis of the risk for the area under observation. ERICA quantifies and compares the global risk posed by hazardous chemicals found in the environment and can be considered a diagnostic and prognostic method for environmental contaminants in critical and potentially dangerous sites, such as incinerators, landfills and industrial areas or in broader geographical areas. The application of the proposed integrated index provides a preliminary quantitative analysis of possible environmental alert due to the presence of one or some pollutants in the investigated site. This paper presents the method and the equations behind the index and a first case study based on the Italian legislation and a pilot study located on the Italian seacoast.