The role of skin tests with polyethylene glycol and polysorbate 80 in the vaccination campaign for COVID-19: results from an Italian multicenter survey.

Summary: Background. International guidelines suggested skin tests with Polyethylene-glycol (PEG) and polysorbate 80 (PS-80), to investigate a possible hypersensitivity to these excipients either to identify subjects at risk of developing allergic reactions to Covid-19 vaccines, or in patients with suspected IgE mediated hypersensitivity reactions (HR) to the Covid-19 vaccine. The main purpose of this study was to investigate the prevalence of PEG and PS sensitization in patients with a clinical history of HR to drugs containing PEG/PS and in patients with a suspected Covid-19 vaccine immediate HR. Methods. This was a multicenter retrospective study conducted by allergists belonging to 20 Italian medical centers. Skin testing was performed in 531 patients with either a clinical history of suspected hypersensitivity reaction (HR) to drugs containing PEG and/or PS-80 (group 1:362 patient) or a suspected HR to Covid-19 vaccines (group 2: 169 patient), as suggested by the AAIITO/SIAAIC guidelines for the "management of patients at risk of allergic reactions to Covid-19 vaccines" [1]. Results. 10/362 (0.02%) had positive skin test to one or both excipients in group 1, 12/169 (7.1%) in group 2 (p less than 0.01). In group 2 HRs to Covid-19 vaccines were immediate in 10/12 of cases and anaphylaxis occurred in 4/12 of patients. Conclusions. The positivity of skin test with PEG and or PS before vaccination is extremely rare and mostly replaceable by an accurate clinical history. Sensitization to PEG and PS has to be investigated in patients with a previous immediate HR to a Covid-19 vaccine, in particular in patients with anaphylaxis.

Recurrent squamous cell carcinoma of the lower lip: salvage surgery outcome.

Squamous cell carcinoma (SCC) of the lip is one of the most commonly occurring oral cancers, mainly involving the lower lip. Despite a good prognosis in cases of early detection, survival rates drop dramatically in the presence of recurrence. While there are many studies in the literature regarding the management of primary tumours, the rate of recurrence in lower lip SCC is low and therefore there are few data and articles about them. We retrospectively reviewed patients affected by recurrent SCC of the lower lip treated surgically from 2011 to 2019 in a single centre. Data and results were compared with those in the literature. A total of 16 patients (mean [range] age: 78.1 [62-93] years) were eligible for inclusion. The disease-free survival rate at 2 and 5 years was 29.6% and the overall survival rate at 2 and 5 years was 14.4%. A significantly higher rate of failure and a worse prognosis was observed in patients with neck involvement. The prognosis of recurrent lower lip SCC is unfavourable with extremely low survival rates. This issue is probably linked to the oncological pathology but also to the advanced age of most patients, the presence of several comorbidities and, consequently, the high risk of perioperative mortality. For this reason, the analysis of data sets reported in the literature may help the surgeon in the management of recurrences and selection of patients.

Management of free flap failure in head and neck surgery.

Free flap surgery is overall considered the gold standard in head and neck reconstruction, with a success rate of 95%. The management of a total flap necrosis and which solution, between a pedicled or a second free flap, is safer for a salvage procedure is still controversial. Object of this study is to describe the authors' management of total free flap loss in head and neck reconstruction and compare the choices and results to those reported in the literature. From January 2012 to January 2016, 149 consecutive free flaps were performed at the Maxillo- Facial Operative Unit of the Hospital Casa Sollievo della Sofferenza in San Giovanni Rotondo (Italy) for reconstruction of head and neck defects. Of these, 6 flaps were lost due to a total necrosis. In 5 cases it was decided to harvest a second free flap, and in the remaining patient a temporalis muscle flap was used. All the free salvage flaps were successful, without complications and with a good aesthetic and functional recovery. Analysing the data obtained, and comparing them with those reported in the literature, it can be concluded that a second subsequent free flap can be considered an ideal and safe procedure in salvage surgery.

Intraoperative navigation in complex head and neck resections: indications and limits.

PURPOSE: The surgical removal of head and neck tumors often represents a highly complex surgery. The three-dimensionality and the anatomy of the head and neck area make sometimes difficult a correct intraoperative orientation and the obtaining of an adequate oncological safety. In the present pilot study, the authors propose a protocol of application of intraoperative navigation in the resection of head and neck tumors. The purpose is to develop a methodology that can be helpful to ensure oncologic free margins of resection and to facilitate the orientation of the specimen by pathologists. MATERIALS AND METHODS: A sample of 16 patients with head and neck tumors was selected, and they were differentiated into two groups: a "study group" treated with CT computer-assisted surgery and a "control group" surgically treated without the use of technology. The following data were analyzed: operative and pre-surgical planning times, issues related to the use of the technologies, respect of the planned landmarks, description and orientation of the surgical specimen and distance of the tumor from the margins of resection. RESULTS: In the "study group" were noticed a reduced rate of errors in the specimen orientation and an increased distance of the tumor from the margins of resection. Similar operative times were observed in both groups. CONCLUSIONS: Intraoperative navigation resulted to be a reliable method to improve oncological safety in a selected group of patients.

Endoscopic transnasal approach and intraoperative navigation for the treatment of isolated blowout fractures of the medial orbital wall.

The aim of this study is to describe the reduction of medial orbital wall fractures using a combination of two different techniques: the endoscopic reduction and the navigation aided reconstruction. The endoscopic approach avoids an external incision and allows the observation of the fracture site clearly. Navigation-aided reconstruction is essential to achieve precise and predictable results in orbital reconstruction. It consists in an ideal virtual reconstruction of the target area created using a mirroring tool, and superimposing and comparing the unaffected and the affected sides. This technique opens a broad spectrum of possible surgical approaches, especially in situations in which anatomical landmarks for precise positioning of bone fragments, or bone grafts, are missing. This study is the first to combine these two techniques. The study was carried out in seven patients who underwent endoscopic reduction of isolated blowout fractures of the medial orbital wall and navigation-aided reconstruction at the authors' institution. This pilot study clearly shows that a combination of the endoscopic reduction and the navigation-aided reconstruction provides functional results and great advantages in terms of anatomical preservation and postoperative morbidity.

Endoscopic laser-assisted dacryocistorhinostomy DCR with the placement of a customised silicone and Teflon bicanalicular stent Endoscopic laser-assisted dacryocystorhinostomy (DCR).

INTRODUCTION: We present our experience in endoscopic laser assisted dacryocystorhinostomy (DCR) analyzing the results obtained with a new technique that involves placing bicanalicolar silicone stent more Teflon tube, in combination with paraseptal silastic sheet. MATERIALS AND METHODS: In our study 49 of 57 patients (85%) at a mean follow up of at least 12 months have not reported epiphora or more episodes of acute dacryocystitis. RESULTS: 49 out of the 57 patients (85%) in our group reported no additional epiphora or episodes of acute dacryocystitis. CONCLUSIONS: Endoscopic DCR is currently the gold standard for sac and post-sac stenosis given the minimal invasiveness of the procedure and the long-term results that appear comparable to those obtained with extrinsic DCR. The principal problem is cicatricial stenosis that can occlude the stoma over time.

Pre-clinical evaluation of a new coral-based bone scaffold.

Coral is used worldwide for bone reconstruction. The favorable characteristics that make this material desirable for implantation are (i) osteoinduction, (ii) and osteoconduction. These proprieties have been demonstrated by in vivo studies with animal models and clinical trials over a twenty-year period. Also poly(2-hydroxyethylmethacrylate) [poly(HEMA)] is a widely used biomaterial. By using coral and poly(HEMA), a scaffold for bone reconstruction application has been recently synthesized. Cytological, histological and genetic analyses were performed to characterize this new alloplastic material. Four samples were analyzed: (a) white coral (WC), (b) red coral (RC), (c) WC plus polymer (WCP) and (d) RC plus polymer (RCP). Quantification of mitochondrial dehydrogenase activity by MTT assay was performed as indirect detector of cytotoxicity. In vivo effects were revealed by implanting corals and coral-based polymers in rabbit tibia. Samples were collected after 4 weeks and subjected to histological analysis. To evaluate the genetic response of cells to corals and coral-derived polymers an osteoblastlike cell line (i.e. MG63) was cultured in wells containing (a) medium, (b) medium plus corals and (c) medium plus two types of scaffolds (RCP or WCP). RNAs extracted from cells were retro-transcribed and hybridized on DNA 19.2K microarrays. No cytotoxicity was detected in corals and coral-based biopolymers. No inflammation or adverse effect was revealed by histological examination. By microarray analysis 154 clones were differentially expressed between RC and WC (81 up and 73 down regulated) whereas only 15 clones were repressed by the polymer. Histological evaluation not only confirmed that coral is a biocompatible material, but also that the polymer has no adverse effect. Microarray results were in agreement with cytological and histological analyses and provided further data regarding the genetic effects of RC, WC and the new polymer.

Adenoid cystic carcinoma of intraoral minor salivary glands.

We present a retrospective multicentric study of 67 patients with adenoid cystic carcinomas of the intraoral minor salivary glands, who were diagnosed and treated between 1986 and 2004 in the Operative Units of Maxillofacial Surgery of the University of Parma and of the Bellaria Hospital in Bologna. There were 28 males and 39 females with a mean age of 54.5 years (range 28-84 years). The palate was the most common site of involvement, with 71.6% of cases. All the patients were treated with surgery as the primary modality. Neck dissection was performed in 9% of the patients, and more than half (59.7%) were treated with adjuvant radiation therapy. All surviving patients had a minimum of 2 years follow-up, with a range of 2-20 years (median: 12 years). Of the 67 patients examined in this study, 19 were dead at the end of the follow-up, 16 of them due to tumor disease. Distant or loco-regional recurrence was documented in 29 of the 67 patients (43.3%). Disease-free intervals ranged from 1 month to 12 years. Twenty-two percent of patients had loco-regional failure, whereas 29.8% had distant metastases. The disease specific survival rates were 76.1% at 5 years and 74% at 10 and 15 years.The actuarial loco-regional control rates at 5-, 10- and 15-years were 79.7%, 74.8% and 70%, respectively. The actuarial freedom from distant relapse was 76.5% at 5 years, 64.9% at 10 years and 61.1% at 15 years. Stage T, cervical lymph node metastasis and surgical margin status proved to make a statistically significant contribution when describing the outcome.

Giant cell tumor of the upper cervical spine: transmandibular-translingual access. Clinical case.

The authors describe the clinical case of a patient aged 18 years affected with giant cell tumor (GCT) at C3 who came to the surgical unit of Orthopaedics and Traumatology at the Ospedale Maggiore in Bologna after being treated by surgery elsewhere. Particular attention is paid to surgical access by means of median transmandibuloglossotomy used in order to obtain a sufficiently wide surgical field that can adequately expose the vertebral segment affected by neoplastic disease. In particular, possible complications that may be observed postsurgery can be compared to other surgical approaches to the upper cervical spine and above all that there are no permanent clinical sequelae.

Treatment of carcinoma of the parotid gland: the results of a multicenter study.

PURPOSE: This study analyzed the prognostic factors for carcinoma of the parotid gland and the role of surgery alone or with radiotherapy in treating these lesions. METHODS: Forty-five patients with malignant parotid tumors were studied retrospectively. Patients were treated by combined surgery and radiation therapy between 1984 and 1995 at the Maxillo-Facial Departments of the General Hospitals of Bologna and Parma. Resection was conservative when possible, depending on the extent of the tumor. The median follow-up time was 54 months. Data regarding incidence, tumor stage and grade, local control, distant metastases (calculated with the Kaplan-Meier method), and survival were analyzed. Cox's multiple linear regression was used to identify patient and tumor characteristics with the greatest prognostic significance. RESULTS: The actuarial 5- and 8-year disease-free survival rates were 81% and 62%, respectively. Multivariate analysis showed that tumor stage was a more prognostic variable than tumor grade. Residual microscopic disease at the excision margins was also an important prognostic variable. Laterocervical metastases affected 4 patients (9%), and distant metastases appeared in 8 patients (18%). CONCLUSIONS: Postoperative irradiation is indicated for patients with stage III and IV disease, patients with positive excision margins, and for patients with lymph node metastases.

[Metastasis of pleural malignant mesothelioma to the brain and upper maxilla: description of 2 cases]. / Metastasi di mesotelioma maligno pleurico all'encefalo e al mascellare superiore: descrizione di due casi.

Two cases of malignant mesothelioma metastatic to the brain and maxillary bone respectively are reported. This latter localization has never been described in literature. The diagnosis resided primarily on immunohistochemistry.

Hemimandibular hyperplasia: treatment strategies.

Hemimandibular hyperplasia is a well-defined, rare asymmetrical mandibular malformation. It is characterized by diffuse enlargement of the condyle, the condylar neck, and the ramus and body of the mandible. Because the anomaly begins before puberty, it is understandable that the maxilla follows the downward growth of the mandible. Pathogenesis is due most likely to clear hyperactivity in the condyle, which can be documented histologically with an actively proliferating cartilage. Therapy is largely based on the patient's age. The authors present their series of nine individuals with hemimandibular hyperplasia treated with various surgical methods between 1992 and 1994. A therapeutic approach called orthopedic maxillary management applied to two of the nine patients is presented. The objective is to maintain the occlusal maxillary plane in a correct position in growing patients. All clinical results, except one, were satisfying and showed good postoperative stability.

Prevalence of hypertension in patients on peritoneal dialysis: results of an Italian multicentre study.

BACKGROUND: The tenet that peritoneal dialysis is capable of either normalizing or improving blood pressure control in uraemic patients is based on outdated or monocentric experiences. Therefore, we assessed the prevalence of hypertension and the efficacy of antihypertensive therapy in a large, multicentric cohort of patients on peritoneal dialysis. METHODS: Twenty seven out of the 50 centres belonging to the Italian Co-operative Peritoneal Dialysis Study Group took part in the study. The main patient selection criteria were: peritoneal dialysis therapy for at least 3 months and no peritonitis or changes in dialysis technique for at least 1 month. Clinical blood pressure was measured according to WHO/ISH guidelines. Ambulatory blood pressure monitoring was carried out using a SpaceLabs 90207 recorder. Hypertension was defined according to WHO/ISH criteria and staged according to the criteria of the Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure (JNC), 5th Report. Ambulatory blood pressure monitoring recordings were used to evaluate white-coat hypertension, blood pressure load and the dipping phenomenon. RESULTS: Five hundred and four subjects were evaluated. Hypertension was prevalent in 88.1% of the population, and 362 out of 444 hypertensive patients were on antihypertensive therapy. JNC staging revealed that 188 patients had moderate to severe hypertension. Blood pressure load was pathological in 77.3% of the patients receiving antihypertensive treatment. White-coat hypertension was identified in 9.1% of the hypertensive patients not on antihypertensive therapy, and 53.1% of the patients were non-dippers. CONCLUSIONS: The study demonstrates that hypertension is a dramatic, unsolved problem in uraemic patients treated with peritoneal dialysis, and casts doubts on the effectiveness of our current peritoneal dialysis strategies and pharmacological management of hypertension.

Myths and reality concerning hypertension in peritoneal dialysis patients: results of a multicenter study.

OBJECTIVES: To evaluate the prevalence of hypertension, the average blood pressure level, the 24 h blood pressure profile, and the efficacy of antihypertensive therapy for a large population of peritoneal dialysis patients.DESIGN: A cross-sectional, observational multicenter study. METHODS: From 504 peritoneal dialysis patients (18% of the Italian peritoneal dialysis population) involved in a multicenter observational study, we selected 414 who had undergone successful ambulatory blood pressure monitoring (i.e. no hours with data absent, >/= 75% successful readings and monitoring duration >/= 24 h). Office blood pressure measurements and ambulatory blood pressure monitoring were performed for each patient on the same day with a standard mercury sphygmomanometer and a SpaceLabs 90207 device, respectively.RESULTS: According to World Health Organization/International Society of Hypertension criteria, 44 peritoneal dialysis patients (10.6%) were normotensive and 370 patients (89.4%) were hypertensive, 304 (82.1%) of whom were being administered antihypertensive therapy. Daytime systolic and diastolic blood pressures were both significantly lower than office systolic and diastolic blood pressures (140.7 +/- 19.7/72.1 +/-11.1 versus 148.3 +/- 23.6/85.6 +/- 12 mmHg; P < 0.001). The difference between office blood pressure and daytime blood pressure was significantly correlated to office blood pressure (P < 0.001 for systolic and P < 0.001 for diastolic). The diurnal blood pressure rhythm evaluated by visual inspection of hourly mean plots was not influenced by sex, age, antihypertensive treatment, and peritoneal dialysis modality. Systolic and diastolic blood pressures exhibited a day-night mean decreases of 8.6 +/- 11.7 and 7.7 +/- 6.9 mmHg, respectively, and daytime blood pressure values were significantly higher than night-time ones (P < 0.001). Two hundred and twenty patients (53.1%) were nondippers according to O'Brien's criteria, 247 patients (59.7%) were nondippers according to Verdecchia's criteria, and 269 patients (65.0%) were nondippers according to Staessen's criteria. Only 39 patients (9.4%) had a reversed circadian rhythm. The day-night differences of systolic and diastolic blood pressures were in a unimodal distribution. Among hypertensive patients not being administered antihypertensive therapy, only six patients ( five women and one man) had white-coat hypertension. Among hypertensive patients being administered antihypertensive therapy, 235 patients (77.3%) had 24 h blood pressure loads > 30%.CONCLUSION: There is a high prevalence of hypertension among peritoneal dialysis patients. White-coat hypertension is very rare in this population. Despite the extensive use of antihypertensive therapy, control of blood pressure is maintained in a large number of our peritoneal dialysis patients. Any classification of patients into dipers and nondippers must be interpreted cautiously.

[Solitary fibrous tumor of the cheek]. / Tumore solitario fibroso della guancia.

INTRODUCTION: A case of solitary fibrous tumour of the cheek is described. MATERIAL AND METHODS: The lesion is documented by immunohistochemistry. RESULTS: The patient is a 55 year old man and the tumor is constituted by a nodule measuring 2 cm in its greatest axis. The neoplastic cells are spindle shaped and arranged in a storiform pattern. They stain for vimentin and CD34. DISCUSSION: The differential diagnosis from morphologically similar lesions, such as leiomyoma, schwannoma, benign fibrohistiocytoma and myoepithelioma of the salivary glands was taken in consideration. The present case, together with those reported in the literature, indicates that solitary fibrous tumours arise in any site of the organism.

[Free-flap fibula for the reconstruction of composite mandibular defects]. / Il lembo libero microvascolare di perone nella ricostruzione di difetti mandibolari complessi.

The advent of microsurgery has revolutionized the reconstruction of composite tissue defects of the mandibular region. Well-vascularized bone and soft-tissues can be used to repair any kind of oromandibular defects and many of the morphological and functional goals of mandibular reconstruction can now be achieved. The ideal flap should provide a vascularized bone of sufficient length and height, easily shaped to match the original mandible with a thin, abundant soft-tissue component. The donor site morbidity should be minimal and a two-team approach possible. Different flaps have been used for mandibular reconstruction including fibula, iliac crest, radius and scapula. According to us, fibula free-flap satisfies many of these requirements and is the flap of choice in most cases of difficult mandibular reconstruction. 8 fibula free flaps were used in 6 cases of primary and 2 cases of secondary reconstructions. The defects were secondary to resections of oral cancers in 4 cases and of osteosarcomas in 4 cases. The mandibular defects were between 8 and 16 cm in length. Multiple osteotomies were used to shape the bone and miniplates were utilized for rigid fixation of the osteotomized bone and of the remaining mandible. An important soft-tissue defect was present in 6 cases requiring a skin paddle for oral lining. In 6 cases there was a complete survive of the flaps with very satisfactory results and good mandibular contour. There was one flap failure for a venous thrombosis and in one case the flap was removed after 8 days for complications independent of the microvascular technique. Donor site morbidity was minimal with no significant gait disturbance. In conclusion, the advantages of microvascular surgery and the reliability of fibula free-flap make it an attractive and versatile option in one-stage reconstruction of composite tissue defects in the mandibular region.

Prevalence of hyperlipidemia in a cohort of CAPD patients. Italian Cooperative Peritoneal Dialysis Study Group (ICPDSG).

An association between hyperlipidemia and cardiovascular disease is well described in the literature. We conducted an observational study in order to evaluate the lipid profile, the prevalence of hyperlipidemia and its relationship with age, sex, duration of CAPD, peritoneal glucose load (PGL), serum albumin (ALB), serum glucose (GLU), and BMI in a large cohort of uremics undergoing long-term treatment with CAPD. 457 nondiabetic patients (245 males, 212 females; mean age 63.8 +/- 11.9 years; mean duration of CAPD: 41.8 +/- 26.9 months) treated during 1992 in 25 centers participating in the Italian Cooperative Peritoneal Dialysis Study Group (ICPDSG) were studied. The serum lipid parameters evaluated were triglycerides (TG), total cholesterol (CHO), HDL-cholesterol (HDL). Indications given in the New England Journal of Medicine, SI Unit Conversion Guide, 1992, were adopted for normal ranges. In the whole population the evaluation of lipid parameters showed: TG 227.4 +/- 123.3 mg/dl, CHO 232.8 +/- 56.0 mg/dl, HDL 40.7 +/- 12.0 mg/dl. No differences were found between the two sexes with regard to age, BMI, duration of CAPD, distribution of renal diseases, TG, ALB, and GLU; whereas CHO and HDL were significantly lower in males than in females (CHO: 222.2 +/- 53.5 vs. 245.0 +/- 56.5 mg/dl, p < 0.001; HDL: 39.3 +/- 11.4 vs. 42.6 +/- 12.6 mg/dl, p < 0.05). The prevalence of hypercholesterolemia was significantly lower in males than in females (19.7 vs. 35.4%; p < 0.001). The multiple regression analysis indicated that TG were directly correlated to PGL (p < 0.05), and HDL was inversely correlated with TG (p < 0.001). The coexistence of the two variables (TG and HDL) may increase the risk of cardiovascular events. Further strategies should therefore be developed to select and manage CAPD patients to reduce the incidence of hyperlipidemia.

Longitudinal assessment of body composition in CAPD patients using bioelectric impedance analysis. A comparison with hemodialysis patients.

The utility of bioelectric impedance analysis was assessed for longitudinal evaluation of body composition in two groups of uremic patients, one on CAPD and one on hemodialysis treatment, with no clinical marks of hyperhydration or infection. Nineteen CAPD patients (11 men 8 women) and 21 HD patients (12 men 9 women) were studied with bioelectric impedance analysis for a period of 12 months; total body water, fat free mass, and fat mass were calculated from bioelectric impedance analysis data of resistance and reactance at time 0 and 12 months later. No significant differences in body composition were found in the two groups at time 0 and 12 months later, with a similar trend for total body water, fat free mass, and fat mass. In CAPD, a significant increase in body weight was observed due mainly to a rise in fat mass, particularly evident in women with uremia. Bioelectric impedance analysis appears to be an instrument easily repeatable and reliable in CAPD and HD patients, reflecting at the same time body composition, the dialytic adequacy of a technique, and the patient's well being.