Pathology and Forensic Medicine, Toxicology, Health Professions
51
Scopus Publications
Scopus Publications
Augmentation Mammoplasty Under Tumescent Local Anesthesia: A Multicenter Retrospective Analysis of 1644 Consecutive Cases—Safety and Efficacy in Subglandular and Submuscular Approaches Emilio Trignano, Silvia Vacca, Federico Ziani, Giovanni Arrica, Sofia De Riso, Antonio Rusciani, Anna Manconi, Claudia Trignano, Corrado Rubino Journal of Clinical Medicine, 2026 Background: Breast augmentation is traditionally performed under general anesthesia, but tumescent local anesthesia (TLA) offers advantages in terms of rapid recovery and reduced risks. This study presents the largest European series on the use of TLA for breast augmentation, analyzing the cumulative results of 16 years of experience. Methods: A multicenter retrospective analysis was conducted on 1644 consecutive patients (982 subglandular and 662 subpectoral) between 2008 and 2024. All procedures were performed under TLA with conscious sedation without the use of general anesthesia. The tumescent solution consisted of 25 mL of 2% lidocaine, 8 mEq of sodium bicarbonate, and 1 mL of epinephrine (1 mg/1 mL) in 1000 mL of 0.9% saline solution. Infiltration protocols differed between groups: the subglandular approach utilized a single-plane technique (mean 589 mL per breast), whereas the subpectoral approach required a two-stage process (pre-fascial and retromuscular) with a higher mean volume (770 mL per breast). Intraoperative parameters, complication rates, and patient-reported outcomes (BREAST-Q) were analyzed. Statistical comparisons between the two surgical planes were performed using Independent Samples T-tests. Results: The procedure was successfully completed under TLA in 100% of cases, with no conversions to GA. The subpectoral approach was associated with significantly higher mean operating times (141 ± 11.2 min vs. 90.3 ± 11 min; p < 0.001) and TLA solution volumes (770 ± 16.1 mL vs. 589 ± 53.6 mL; p < 0.001). The overall major complication rate was 4.74%, with a significantly higher incidence of hematoma in the subpectoral group compared to the subglandular group (3.51% vs. 1.83%; p = 0.015). Regarding severe capsular contracture (Baker III–IV), although a slightly higher incidence was observed in the subpectoral cohort compared to the subglandular group (2.11% vs. 1.22%), this difference was not statistically significant (p = 0.155). Patient satisfaction via Breast-Q was high, with dissatisfaction exclusively linked to implant dislocation. Conclusions: This 16-year cumulative analysis validates TLA as a safe, effective, and reproducible alternative to general anesthesia for both subglandular and subpectoral breast augmentation. While the subpectoral plane entails longer surgical times and a slightly higher risk of minor complications, the TLA protocol ensures excellent pharmacological safety and rapid functional recovery, supporting its use in modern outpatient surgical settings.
A New Way to Wrap: Innovative ADM Braxon Packaging Technique Reduces Seroma in Prepectoral Breast Reconstruction Giovanni Arrica, Corrado Rubino, Federico Ziani, Edoardo Filigheddu, Sofia De Riso, Gianluca Marcaccini, Roberto Cuomo, Claudia Trignano, Emilio Trignano Journal of Clinical Medicine, 2026 Background: In recent years, prepectoral implant-based breast reconstruction supported by acellular dermal matrices (ADMs) has become an increasingly adopted alternative to submuscular techniques. Although this approach can improve patient comfort and aesthetic outcomes, fluid accumulation around the implant remains one of the most frequent and clinically relevant complications. Our unit progressively modified the handling and wrapping of the Braxon® ADM with the aim of optimizing pocket configuration and reducing seroma formation. Methods: We performed a retrospective analysis of consecutive patients who underwent immediate prepectoral, direct-to-implant breast reconstruction with Braxon® ADM at our institution between October 2019 and January 2025. Two techniques were compared: a standard full-wrap configuration and a modified approach in which the posterior ADM sheet is trimmed and only anterior coverage is maintained, with fenestrations created in the anterior wall. Clinical data and postoperative complications, including seroma rates, were recorded and compared between groups. Categorical variables were summarized as counts and percentages, and continuous variables as means and standard deviations. The primary comparison between techniques was performed on the presence of at least one postoperative complication using Fisher’s exact test, and odds ratios (OR) with 95% confidence intervals (CI) were calculated where appropriate. A p-value <0.05 was considered statistically significant. Results: A total of 138 direct-to-implant prepectoral reconstructions were included, 90 performed with the standard full-wrap technique and 48 with the modified wrapping approach. The overall complication rate was 27.8% (25/90) in the standard group and 10.4% (5/48) in the new-technique group. Seroma occurred in 8 patients (8.9%) in the standard group and in 1 patient (2.1%) in the modified-technique group. Fisher’s exact test demonstrated a significantly lower overall complication rate in the modified-technique cohort (10.4% vs. 27.8%; p = 0.02; OR 3.31; 95% CI 1.18–9.31), indicating that patients treated with the standard technique had approximately 3.3-fold higher odds of developing at least one complication than those treated with the modified technique. Conclusions: Anterior-only ADM coverage with selective trimming of the posterior sheet and fenestration of the anterior wall appears to reduce complications, particularly seroma, in ADM-assisted prepectoral breast reconstruction. Small technical refinements in ADM handling and pocket configuration, combined with a structured drainage protocol, may substantially improve postoperative outcomes in this setting.
Acute Intoxication After Baclofen Administration: A Review of the Literature and Methodological Proposals Giuseppe Davide Albano, Mauro Midiri, Péter Attila Gergely, Tamás Gergő Harsányi, Kálmán Racz, Alessandra Matilde Nivoli, Roberto Buscemi, Stefania Zerbo, Antonina Argo, Claudia Trignano Toxics, 2025 Baclofen intoxication, once rare, is now increasingly observed in clinical and forensic settings due to its expanding medical and off-label use. However, baclofen is not routinely included in standard postmortem toxicological panels and is usually tested only when explicitly requested. This selective approach, together with the lack of validated cut-offs and standardized interpretative protocols, complicates both clinical management and postmortem evaluation. A systematic review of the literature published between July 2005 and July 2025 was conducted according to PRISMA guidelines, including fatal and non-fatal baclofen intoxications with quantitative toxicological data. Analytical methods, biological matrices, concentration ranges, and clinical outcomes were compared to identify recurring patterns and interpretative gaps. A fatal intrathecal overdose case was also analyzed as a paradigmatic example of diagnostic and methodological challenges. In thirteen studies meeting inclusion criteria and comprising over 300 cases, reported blood concentrations ranged from 0.04 to 110 mg/L, with overlapping values between survivors and fatalities. The analysis revealed marked heterogeneity in matrices and methods, and a poor correlation between concentration and clinical severity, limiting the reliability of toxicological interpretation in both clinical and postmortem settings. Baclofen intoxication illustrates the challenges of interpreting toxicological data without harmonized analytical criteria and highlights the need for standardized procedures and shared reference databases to improve diagnostic and medico-legal accuracy.
Trace Elements in Post-Mortem Tissues: A Review of Current Evidence and Forensic Challenges Claudia Trignano, Angela Sabalic, Andrea Pisano, Davide Tutedde, Pablo Hernández-Camarero, Raffaele La Russa, Macarena Perán, Roberto Madeddu Toxics, 2025 Background: Trace elements and heavy metals can provide valuable forensic information for individual identification, lifestyle reconstruction, and association with the scene or time of death and may also assist in linking objects to criminal activities. However, the lack of standardized guidelines and post-mortem reference values represents a significant limitation in forensic investigations. Methods: This review was conducted in accordance with the PRISMA statement. We performed a comprehensive literature study over the last ten years focusing on the analysis of trace elements and heavy metals in post-mortem tissues. Results: The search results from the databases yielded 247 records. The screening, according to PRISMA criteria, allowed us to select and include 19 articles. The results showed the need for standardized guidelines and reference values. Although post-mortem trace element analysis shows high potential for forensic applications, substantial methodological heterogeneity persists. Some studies have proposed preliminary reference values for cadmium (Cd) in kidneys and mercury (Hg) in hair but validated post-mortem reference ranges remain largely unavailable. Conclusions: The current literature demonstrates the forensic potential of trace element and heavy metals analysis including Cd, Hg, lead (Pb), Manganese (Mn), Aluminum (Al), Copper (Cu), Zinc (Zn), Iron (Fe), Thallium (Tl), Polonium (210Po) but also underlines the urgent need for standardized protocols and validated post-mortem reference values to improve interpretability and reliability in forensic contexts.
Integrated Reconstructive Management of Periocular Complications Following Bilateral Blepharoplasty Matilde Tettamanzi, Giovanni Muratore, Federico Ziani, Giovanni Arrica, Claudia Trignano, Corrado Rubino, Emilio Trignano Plastic and Reconstructive Surgery Global Open, 2025 Summary: The correction of iatrogenic ectropion of the lower lid represents one of the most complex surgical challenges for the plastic surgeon. These complications compromise both the functionality and aesthetics of the periocular area, and corrective interventions aim to restore the functionality and anatomy of the region. The combination of multiple complications often requires the use of various surgical techniques to resolve the problem. We present the clinical case of a 46-year-old woman who came to our attention following bilateral upper and lower blepharoplasty performed in a private facility by another professional approximately 6 months ago. She presented with third-degree ectropion and lagophthalmos of the left lower eyelid, and second-degree ectropion of the right lower eyelid. Surgical interventions to correct these problems often require skin and cartilage grafts, which often result in recurrences and suboptimal scarring outcomes. The patient expressed reluctance toward the adoption of skin and cartilage grafts taken from another site, so it was decided to opt for correction through a midface lift, lateral canthoplasty, tarsal strip, and conjunctival excision. The follow-up confirmed the success of the surgical procedure, allowing for the correction and restoration of eyelid functionality and aesthetics, without the need for third-party donor sites and with great patient satisfaction.
Medial Thigh Lift with Tumescent Local Anesthesia: Advancing Outpatient Body Contouring Federico Ziani, Edoardo Filigheddu, Giovanni Arrica, Sofia De Riso, Gianluca Marcaccini, Roberto Cuomo, Claudia Trignano, Corrado Rubino, Emilio Trignano Journal of Clinical Medicine, 2025 Background: Demand for anesthesia-sparing body contouring techniques is rising. This study assessed the feasibility, safety, and outcomes of medial thigh lift performed exclusively under tumescent local anesthesia (TLA) in an outpatient setting. Methods: A retrospective review was conducted that included 43 female patients (mean age of 41.6 years; BMI of 27.6 kg/m2) treated from November 2019 to June 2023. All procedures used pure TLA without sedation; a horizontal excision alone or combined with liposuction was chosen according to preoperative evaluation. The end-points were operative time, intra-operative pain (four-point scale), complications, and 12-month patient satisfaction. Results: Surgery was completed under TLA in every case, with no conversion to general anesthesia. The median operative time was 30 min for excision-only procedures and 50 min when combined with liposuction. Intra-operative comfort was rated “excellent” (86.0%) or “good” (14.0%); no opioids were required postoperatively. The overall complication rate was 23.2% (10/43), limited to minor wound dehiscence (9.3%), dog-ear deformity (7.0%), and scar displacement/hypertrophy (7.0%). No seroma, hematoma, infection, thromboembolic events, sensory deficits, or hospital readmissions occurred. All patients were discharged after 4 h and resumed ambulation within 24 h. At 12 months, 97.7% reported being “very satisfied” or “satisfied.” Conclusions: Medial thigh lift under pure TLA provides reliable anesthesia and hemostasis, minimizes perioperative morbidity, and enables same-day discharge, with high patient satisfaction. The low incidence of only minor complications supports TLA as a safe, effective, and resource-efficient alternative to general anesthesia for selected patients with mild-to-moderate thigh laxity. Further comparative and long-term studies are warranted.
Advancing Reduction Mammaplasty Surgery: Advancements and Outcomes with Tumescent Local Anaesthesia Giovanni Arrica, Matilde Tettamanzi, Federico Ziani, Edoardo Filigheddu, Claudia Trignano, Corrado Rubino, Emilio Trignano Aesthetic Plastic Surgery, 2025 Background Tumescent local anaesthesia (TLA) is a method of anaesthesia used for surgical procedures that involves the infusion of a saline solution containing lidocaine, sodium bicarbonate, and epinephrine. This anaesthetic technique is designed to achieve both vasoconstriction and anaesthesia. In this article, we present a modified TLA protocol specifically adapted for reduction mammaplasty, based on an analysis of clinical case histories collected over the past few years. Methods During the period from 2012 to 2022, we performed a reduction mammaplasty procedure in 120 patients employing tumescent local anaesthesia (TLA). The composition of the tumescent solution included 25 mL of 2% lidocaine, 8 mEq of sodium bicarbonate, and 1 mL of epinephrine (1 mg/1 mL) in 1000 mL of 0.9% saline solution. The solution was injected diffusely throughout the mammary gland. Results The average volume of tumescent solution infiltrated during TLA was 350 mL per breast. There were no cases of adrenaline or lidocaine toxicity, and no patients required conversion to general anaesthesia. No patient received sedation. Patients reported no pain or discomfort during pre-operative infiltration or during surgery. No reinterventions were necessary because of short-term complications. Among the complications, there were 4 cases of hematoma (3,3%), 3 cases of seroma (2,55%), 10 cases of wound dehiscence (8,3%), 5 cases of asymmetry (4,1%), 9 cases of T-junction breakdown (7,5%), 2 cases of (partial) nipple necrosis (1,6%), and 3 cases of liponecrosis (2,5%). No cases of infection or total nipple-areola loss were reported. The follow-up period was between 30 days and 1 year. Conclusions Reduction mammaplasty is a viable surgical option for women with macromastia seeking to enhance their physiognomy. It is imperative that patients fully understand the potential benefits and risks associated with the procedure and consult with healthcare professionals specialising in this field. The use of tumescent local anaesthesia (TLA) has been confirmed as a safe and effective methodology to perform reduction mammaplasty, ensuring adequate pain control with minimal post-operative complications and resulting in a high degree of patient satisfaction. Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Pharmacogenetic Information on Drug Labels of the Italian Agency of Medicines (AIFA): Actionability and Comparison Across Other Regulatory Agencies Antonino Moschella, Soumaya Mourou, Samantha Perfler, Enrico Zoroddu, Daiana Bezzini, Dorian Soru, Claudia Trignano, Monica Miozzo, Alessio Squassina, Erika Cecchin, Matteo Floris Clinical and Translational Science, 2025 To plan future steps for the implementation and regulation of pharmacogenetic testing, any issue in the management of pharmacogenetic information by regulatory bodies must be identified. In this paper, an analysis of pharmacogenetic information in the summary of product characteristics (SmCPs) of drugs approved by Italian Drug Agency (AIFA) was conducted. Among 4214 SmCPs of 1063 active ingredients, 53.2% (n = 2240) included pharmacogenetic information in at least one section, most frequently for drugs in the Anatomical Therapeutic Chemical category “Antineoplastic and immunomodulatory agents”. To contextualize these data in the international scenario, a pharmacogenetic level of actionability, based on AIFA SmCPs, was assigned to 608 drug/gene pairs included in FDA's “Table of Pharmacogenomic Biomarkers in Drug Labels”, according to PharmGKB (The Pharmacogenomics Knowledge Base). Approximately 67% of drug/gene pairs were deemed classifiable: Based on SmCPs phrasing, for half of them the genetic testing was cataloged as “required” or “recommended” (mainly tumor somatic variants), whereas 40% as “actionable” (mostly PK/PD‐related germline variants). The comparison with other regulatory agencies highlighted a discordance in the assigned pharmacogenetic levels of actionability ranging from 1% to 14%. This discrepancy may also point out the need to rethink the language used in AIFA‐approved SmCPs to clarify whether a pharmacogenetic test is necessary or not and for which subjects it has been recommended. For the first time, a detailed evaluation and comparative analysis of the pharmacogenetic information on Italian SmCPs was presented, placing it in an international context and laying the groundwork for rethinking pharmacogenetic indications in AIFA‐approved SmCPs.
