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Kloth J.S.L.,Netherlands Cancer Institute | Pagani A.,Fondazione S. Maugeri | Verboom M.C.,Leiden University | Malovini A.,Salvatore Maugeri Research and Care Institute | And 6 more authors.
British Journal of Cancer | Year: 2015

Background: Tyrosine kinase inhibitors (TKIs) are associated with prolongation of the QTc interval on the electrocardiogram (ECG). The QTc-interval prolongation increases the risk of life-threatening arrhythmias. However, studies evaluating the effects of TKIs on QTc intervals are limited and only consist of small patient numbers. Methods: In this multicentre trial in four centres in the Netherlands and Italy we screened all patients who were treated with any TKI. To evaluate the effects of TKIs on the QTc interval, we investigated ECGs before and during treatment with erlotinib, gefitinib, imatinib, lapatinib, pazopanib, sorafenib, sunitinib, or vemurafenib. Results: A total of 363 patients were eligible for the analyses. At baseline measurement, QTc intervals were significantly longer in females than in males (QTcfemales =404 ms vs QTcmales =399 ms, P=0.027). A statistically significant increase was observed for the individual TKIs sunitinib, vemurafenib, sorafenib, imatinib, and erlotinib, after the start of treatment (median ΔQTc ranging from +7 to +24 ms, P<0.004). The CTCAE grade for QTc intervals significantly increased after start of treatment (P=0.0003). Especially patients who are treated with vemurafenib are at increased risk of developing a QTc of ≥470 ms, a threshold associated with an increased risk for arrhythmias. Conclusions: These observations show that most TKIs significantly increase the QTc interval. Particularly in vemurafenib-treated patients, the incidence of patients at risk for arrhythmias is increased. Therefore, especially in case of combined risk factors, ECG monitoring in patients treated with TKIs is strongly recommended. © 2015 Cancer Research UK. All rights reserved.


PubMed | IRCCS Fondazione S. Maugeri, Netherlands Cancer Institute, Leiden University, Fondazione S. Maugeri and 2 more.
Type: Journal Article | Journal: British journal of cancer | Year: 2015

Tyrosine kinase inhibitors (TKIs) are associated with prolongation of the QTc interval on the electrocardiogram (ECG). The QTc-interval prolongation increases the risk of life-threatening arrhythmias. However, studies evaluating the effects of TKIs on QTc intervals are limited and only consist of small patient numbers.In this multicentre trial in four centres in the Netherlands and Italy we screened all patients who were treated with any TKI. To evaluate the effects of TKIs on the QTc interval, we investigated ECGs before and during treatment with erlotinib, gefitinib, imatinib, lapatinib, pazopanib, sorafenib, sunitinib, or vemurafenib.A total of 363 patients were eligible for the analyses. At baseline measurement, QTc intervals were significantly longer in females than in males (QTcfemales=404ms vs QTcmales=399ms, P=0.027). A statistically significant increase was observed for the individual TKIs sunitinib, vemurafenib, sorafenib, imatinib, and erlotinib, after the start of treatment (median QTc ranging from +7 to +24ms, P<0.004). The CTCAE grade for QTc intervals significantly increased after start of treatment (P=0.0003). Especially patients who are treated with vemurafenib are at increased risk of developing a QTc of 470ms, a threshold associated with an increased risk for arrhythmias.These observations show that most TKIs significantly increase the QTc interval. Particularly in vemurafenib-treated patients, the incidence of patients at risk for arrhythmias is increased. Therefore, especially in case of combined risk factors, ECG monitoring in patients treated with TKIs is strongly recommended.


Nicoletti G.,University of Pavia | Nicoletti G.,Salvatore Maugeri Research and Care Institute | Brenta F.,University of Pavia | Brenta F.,Salvatore Maugeri Research and Care Institute | And 5 more authors.
Foot | Year: 2014

Background: New advances in regenerative surgery may increase the potential for rehabilitation in the injured foot. Objectives: A clinical prospective observational study was carried out to assess the effectiveness of lipofilling to improve the functional recovery of the injured foot. Methods: Four patients with anatomical-functional impairment following repair of post-traumatic soft tissue loss of the foot were involved in the study. All of the patients complained of pain in the repaired plantar weight bearing area, skin instability, recurrent ulcerations and were walking on crutches.A combined plastic surgery and technical orthopaedic assessment identified the plantar areas requiring anatomical changes for load redistribution. Two selective sequential lipofillings with a 12 weeks' time interval were performed. Manufacturing of custom-made plantar insoles and/or shoes followed each surgical procedure. Results: After the treatment all of the patients progressively recovered both a better plantar load distribution and a local soft tissue stability, referred the remission of chronic pain and discontinued the use of crutches. Conclusion: Lipofilling proved to be an effective and versatile surgical technique for both reconstructive and regenerative purposes. The interaction between the Plastic Surgery staff and the Orthopaedic Technician outlined a successful multidisciplinary approach model for the rehabilitation of the injured foot. © 2014 The Authors.


Nicoletti G.,University of Pavia | Nicoletti G.,Salvatore Maugeri Research and Care Institute | Icaro Cornaglia A.,University of Pavia | Faga A.,University of Pavia | And 2 more authors.
Photomedicine and Laser Surgery | Year: 2014

Objective: An experimental study was conducted to assess the effectiveness and safety of an innovative quadripolar variable electrode configuration radiofrequency device with objective measurements in an ex vivo and in vivo human experimental model. Background data: Nonablative radiofrequency applications are well-established anti-ageing procedures for cosmetic skin tightening. Methods: The study was performed in two steps: ex vivo and in vivo assessments. In the ex vivo assessments the radiofrequency applications were performed on human full-thickness skin and subcutaneous tissue specimens harvested during surgery for body contouring. In the in vivo assessments the applications were performed on two volunteer patients scheduled for body contouring surgery at the end of the study. The assessment methods were: clinical examination and medical photography, temperature measurement with thermal imaging scan, and light microscopy histological examination. Results: The ex vivo assessments allowed for identification of the effective safety range for human application. The in vivo assessments allowed for demonstration of the biological effects of sequential radiofrequency applications. After a course of radiofrequency applications, the collagen fibers underwent an immediate heat-induced rearrangement and were partially denaturated and progressively metabolized by the macrophages. An overall thickening and spatial rearrangement was appreciated both in the collagen and elastic fibers, the latter displaying a juvenile reticular pattern. A late onset in the macrophage activation after sequential radiofrequency applications was appreciated. Conclusions: Our data confirm the effectiveness of sequential radiofrequency applications in obtaining attenuation of the skin wrinkles by an overall skin tightening. © Mary Ann Liebert, Inc.


Nicoletti G.,University of Pavia | Nicoletti G.,Salvatore Maugeri Research and Care Institute | Jaber O.,University of Pavia | Jaber O.,Salvatore Maugeri Research and Care Institute | And 6 more authors.
Facial Plastic Surgery | Year: 2015

The authors propose a prefabricated chondromucosal composite graft to reconstruct full-thickness defects of the lower eyelid. The technique was used in a patient suffering from a locally invasive basal cell carcinoma of the lower eyelid, who had previously undergone an extensive submucosal nasal septum resection. One week prior to the eyelid resection, the anterior skin surface of the auricular concha was replaced with a full-thickness oral mucosa graft. One week later, a full-thickness excision of the right lower eyelid was performed and the prefabricated chondromucosal auricular graft was used to restore the posterior lamella. The anterior lamella was reconstructed with a bipedicled myocutaneous flap from the upper eyelid. Because of the patient's scheduling needs, the medial pedicle of the flap was divided 28 days later and the lateral one after further 37 days. All the procedures were performed under local anesthesia. This technique adds a simple key detail to other time-honored reliable techniques, thus outlining an extremely convenient sequence for full-thickness eyelid reconstruction. The easily prepared prefabricated chondromucosal graft might be associated with any of the previously described flaps, thus providing a versatile and reliable method of posterior lamella reconstruction. © 2015 by Thieme Medical Publishers, Inc.


Jaber O.,University of Pavia | Vischio M.,University of Pavia | Faga A.,University of Pavia | Faga A.,Salvatore Maugeri Research and Care Institute | And 2 more authors.
Archives of Plastic Surgery | Year: 2015

The closure of any circular or asymmetric wound can result in puckering or an excess of tissue known as a ‘dog ear’. Understanding the mechanism of dog ear formation is a fundamental requirement necessary to facilitate an appropriate treatment. Many solutions have been reported in the literature, but in all cases, the correction entails the extension of the scar and the sacrifice of the dermal plexus. Here, we propose a novel technique of dog ear correction by using a three-bite suture that sequentially pierces the deep fascial plane and each dog ear’s margin, thus allowing for flattening the dog ear by anchoring the over-projecting tissue to the deep plane. The three-bite technique proved to be a fast, easy, and versatile method of immediate dog ear correction without extending the scar, while maintaining a full and complete local skin blood supply. © 2015, The Korean Society of Plastic and Reconstructive Surgeons.


Nicoletti G.,University of Pavia | Nicoletti G.,Salvatore Maugeri Research and Care Institute | Brenta F.,University of Pavia | Brenta F.,Salvatore Maugeri Research and Care Institute | And 6 more authors.
Plastic and Reconstructive Surgery | Year: 2014

Background: The embryologic fusion planes might be related with the sites of onset of basal cell carcinoma (BCC), thus supporting an embryologic role for its pathogenesis. Methods: A study involving 495 patients with 627 BCCs of the head and neck was carried out over a period of 5 years by correlating the distribution of all BCCs with the sites of congenital clefts of the head and neck using (1) the original anatomic diagram of the Tessier classification of craniofacial clefts, (2) the anatomic diagram by Moore et al featuring the paths of the "hairline indicators" of craniofacial clefts that represent the cranial extensions of the Tessier classification, and (3) an anatomical diagram featuring the sites of congenital clefts of the neck. Results: The proportion of BCCs localized within a cleft site was significantly higher than those in the noncleft sites. The age of patients with BCCs localized within the Tessier cleft number 3 was the lowest among all cleft regions. Conclusions: A topographic correspondence between the sites of BCCs and the sites of congenital clefts was demonstrated in the head and neck. This evidence would support the hypothesis of an embryologic role for the pathogenesis of BCC. The existence of clusters of embryological stem cells in the sites of fusion and/or merging of embryonic processes might therefore be proposed. There may be special biology/physiology along these cleft lines that predispose BCC formation. Copyright © 2014 The Authors.


Nicoletti G.,University of Pavia | Nicoletti G.,Salvatore Maugeri Research and Care Institute | Brenta F.,University of Pavia | Bleve M.,University of Pavia | And 6 more authors.
Journal of Tissue Engineering and Regenerative Medicine | Year: 2015

The aim of the study was an objective in vivo assessment of skin properties after reconstruction with two artificial dermal substitutes, Integra® and Hyalomatrix®. Twenty-seven patients underwent reconstruction of 36 skin-loss sites with full-thickness skin graft, split-thickness skin graft, Hyalomatrix® bioengineered skin substitute and sequential split-thickness skin graft and Integra® bioengineered skin substitute and sequential split-thickness skin graft. Objective assessments were carried out using three instrumental devices: Multi Probe Adapter System MPA; 22MHz ultrasound skin scan; and Primos Pico for a three-dimensional (3D) skin scan. The skin parameters under study in our sample were: corneometry, transepidermal water loss, elastometry, colorimetry, skin thickness and 3D skin surface pattern. A skin reconstruction with Hyalomatrix seemed to most closely approach the hydration, transepidermal water loss and skin surface 3D pattern of normal skin. A skin reconstruction with Integra seemed to demonstrate the best skin colour feature and elastic properties. Although no statistically significant differences were observed, the descriptive analysis of the outcomes might suggest a better cell regulation, regenerated extracellular matrix and neoangiogenesis with the use of Hyalomatrix, and the formation of a more elastic regenerated dermis, with overall better physical, mechanical and optical properties, with the use of Integra. © 2014 The Authors.


Scevola S.,University of Pavia | Nicoletti G.,University of Pavia | Neri A.,Salvatore Maugeri Research and Care Institute | Faga A.,University of Pavia
Indian Journal of Plastic Surgery | Year: 2014

Madelung's disease is characterised by multiple symmetric abnormal fat masses in the head, neck and upper limbs. Surgical excision or liposuction is the only realistic available option, although palliative in nature. The serial intralipotherapy with phosphatidylcholine/deoxycholate has been proposed as a non-invasive treatment of Madelung's disease. The authors used serial intralipotherapy with phosphatidylcholine/deoxycholate in two patients affected by Madelung's disease. Three injections per lesion per patient were performed with 1 month's interval. Pre- and 6 months′ post-treatment dimensions were assessed with ultrasound scan and patients were observed along a 5 years′ clinical follow-up. A 42.5% average size reduction was reported in all treated lesions. About 33% recurrence rate was observed in the 5 years′ follow-up. We confirm the efficacy of intralipotherapy in the non-invasive palliative treatment of Madelung's disease, as a valid option to reduce the volume and limit the growth of the pathological adipose masses.


PubMed | Plastic and Reconstructive Surgery, University of Pavia and Salvatore Maugeri Research and Care Institute
Type: | Journal: Clinical, cosmetic and investigational dermatology | Year: 2014

A randomized, prospective, controlled study was carried out at the Plastic and Reconstructive Surgery Unit of the University of Pavia, Salvatore Maugeri Research and Care Institute, Pavia, Italy, to evaluate the psychological benefits from corrective medical camouflage (CMC) following surgical treatment for skin cancer of the face. Twenty-four female patients, following recovery from facial skin cancer surgery, were enrolled in the study over a period of 1 year. The study was performed using two health-related quality of life tests, the Satisfaction Profile (SAT-P) test and the Body Uneasiness Test (BUT). The patients were randomized into two groups: group A, patients undergoing CMC; and group B, controls. Both the SAT-P and BUT demonstrated statistically significant better results in the treated patients versus the controls in the following functional parameters: Psychological Functionality (PsF), Physical Functionality (PhF), and Work Performance (WP) for the SAT-P test and Compulsive Self-Monitoring (CSM) for the BUT. The PsF demonstrated a better result 6 months post-treatment. Such a difference was particularly significant when comparing the performance at 6 months versus that at 3 months. The PhF demonstrated a better outcome at 6 months post-treatment. The WP demonstrated a better result comparing the performance at 6 months versus that at 3 months. The CSM demonstrated a better outcome at 6 months post-treatment. The CMC promoted a significant improvement in patients physical appearance and in their self-image and perceived social role as a means of their desire to disguise their body disfiguration.

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