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OBJECTIVE: This phase I clinical trial assessed the use of autologous nasal chondrocyte tissue-engineered cartilage (N-TEC) for functional repair of nasal septal perforations (NSP). BACKGROUND: The most widely used technique to treat NSP, namely interposition grafting with a polydioxanone (PDS) plate combined with a deep temporal fascia (DTF) graft, is still suboptimal towards patient satisfaction and revision rates. METHODS: Patients (n=5, all female, age range: 23-54 years) had a 0.5-2.0 cm diameter NSP. N-TEC was manufactured by expansion and 3D culture of autologous nasal septum chondrocytes into Chondro-Gide® collagen membranes. N-TEC was then shaped intraoperatively and enveloped in the harvested DTF before suturing it into the NSP. Safety (primary outcome) was assessed by the number of serious adverse reactions (SAR) until 12 months. Secondary outcomes included feasibility, assessed by surgical graft manipulation, and efficacy, assessed using subjective scoring (Nasal Obstruction Symptom Evaluation, NOSE, and Visual Analogue Scale, VAS, scores) and objective breathing function tests. Structural closure of NSP after 12 months was defined using endoscopy and computed tomography (CT) scans. RESULTS: NSP treatment by N-TEC implantation was safe and feasible, as no SAR and no challenge in graft manipulation was recorded for any of the patients. One year postoperative, subjective scoring improved in all patients, unless already optimal (average improvement of 23 and 28.6 points out of 100 respectively for NOSE and VAS scores). Objective respiratory function overall confirmed - with the exception of one case - the observations above (average improvement of 172 ml/s). NSP were closed and the mucosae completely healed in three patients. CONCLUSION: Autologous N-TEC is a valid treatment for NSP and warrants further clinical tests.
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PURPOSE: To evaluate whether a vascularized bone graft from the medial femur condyle (MFC) can successfully be used to reconstruct small bone defects (< 4 cm) on the upper extremity other than the scaphoid. PATIENTS AND METHODS: In 7 patients at the age of 28 to 66 years 8 vascularized bone grafts from the MFC were used to reconstruct bone defects on the upper extremity other than the scaphoid. Bone healing, complications, donor side morbidity, and patient´s satisfaction were evaluated. Follow-up was 3 to 40 months. Indications were: two nonunion of the distal radius in spite of several surgical procedures, one defect of the distal radius following a radius fracture with osteoarthritis of the radiocarpal joint, one acute trauma with partial loss of the carpus and radius due to an explosion injury, reconstruction of the first metacarpal (MC) following resection of a giant cell tumour, and three fusions between the 1st and 2nd MC as a salvage procedure after several surgical procedures at the saddle joint. RESULTS: There was a regular bony healing in 4 of the 8 cases; delayed bony healing was seen in three cases after 7, 8, and 9 months. In one case there was only a partial bony healing. Two donor side haematomas required surgical revision. Patient's satisfaction was high with 7 painless cases. CONCLUSION: Free vascularized bone grafts from the medial femur condyle can successfully be used to reconstruct bone defects up to 4 cm of the upper extremity other than the scaphoid.
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Fracturas no Consolidadas , Procedimientos de Cirugía Plástica , Hueso Escafoides , Humanos , Adulto , Persona de Mediana Edad , Anciano , Hueso Escafoides/diagnóstico por imagen , Hueso Escafoides/cirugía , Hueso Escafoides/lesiones , Extremidad Superior/cirugía , Radio (Anatomía)/trasplante , Fémur/trasplante , Trasplante Óseo/métodos , Fracturas no Consolidadas/diagnóstico por imagen , Fracturas no Consolidadas/cirugía , Estudios RetrospectivosRESUMEN
INTRODUCTION: The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions. METHODS AND ANALYSIS: International, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm). ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles. TRIAL REGISTRATION NUMBER: NCT04293146.
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Implantación de Mama , Implantes de Mama , Neoplasias de la Mama , Mamoplastia , Neoplasias de la Mama/cirugía , Femenino , Humanos , Mastectomía , Pezones/cirugíaRESUMEN
BACKGROUND/AIM: Free flap reconstruction with damaged or diseased vessels is a challenging problem. We describe our case series using an arteriovenous loop or bypass surgery with free flaps for complex defect reconstructions at the lower extremity and the pelvic region. PATIENTS AND METHODS: In this single-center retrospective cohort study 11 consecutive patients (mean age=73 years, range=53-88 years) were operated on, between June 2016 and August 2018. Patients were reconstructed with free gracilis flaps (n=8), free latissimus dorsi flap (n=1) and chimeric scapular flap (n=1), respectively. RESULTS: The mean loop length was 30 cm (range=12-40 cm). The loop/bypass revision rate was 27% (3/11), and the overall flap loss rate was 20% (2/10). After a mean follow-up time of 17 months (range=12-24 months), the limb salvage rate was 75% (6/8). CONCLUSION: We successfully reconstructed complex defects with poor recipient vessels using arteriovenous loops or bypass surgery and free flaps.
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Colgajos Tisulares Libres , Músculo Grácil , Procedimientos de Cirugía Plástica , Anciano , Anciano de 80 o más Años , Humanos , Extremidad Inferior , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: Indications for nipple-sparing mastectomy (NSM) have broadened to include the risk reducing setting and locally advanced tumors, which resulted in a dramatic increase in the use of NSM. The Oncoplastic Breast Consortium consensus conference on NSM and immediate reconstruction was held to address a variety of questions in clinical practice and research based on published evidence and expert panel opinion. METHODS: The panel consisted of 44 breast surgeons from 14 countries across four continents with a background in gynecology, general or reconstructive surgery and a practice dedicated to breast cancer, as well as a patient advocate. Panelists presented evidence summaries relating to each topic for debate during the in-person consensus conference. The iterative process in question development, voting, and wording of the recommendations followed the modified Delphi methodology. RESULTS: Consensus recommendations were reached in 35, majority recommendations in 24, and no recommendations in the remaining 12 questions. The panel acknowledged the need for standardization of various aspects of NSM and immediate reconstruction. It endorsed several oncological contraindications to the preservation of the skin and nipple. Furthermore, it recommended inclusion of patients in prospective registries and routine assessment of patient-reported outcomes. Considerable heterogeneity in breast reconstruction practice became obvious during the conference. CONCLUSIONS: In case of conflicting or missing evidence to guide treatment, the consensus conference revealed substantial disagreement in expert panel opinion, which, among others, supports the need for a randomized trial to evaluate the safest and most efficacious reconstruction techniques.
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Neoplasias de la Mama/cirugía , Mamoplastia/métodos , Mastectomía Subcutánea/métodos , Consenso , Femenino , Humanos , Mastectomía Subcutánea/efectos adversos , Necrosis , Pezones/patología , Colgajos Quirúrgicos/patologíaRESUMEN
Objectives: Bone ischemia and necrosis are challenging to treat, requiring investigation of native and engineered bone revascularisation processes through advanced imaging techniques. This study demonstrates an experimental two-step method for precise bone and vessel analysis in native bones or vascularised bone grafts using X-ray microtomography (µCT), without interfering with further histological processing. Methods: Distally ligated epigastric arteries or veins of 6 nude rats were inserted in central channels of porous hydroxyapatite cylinders and these pedicled grafts were implanted subcutaneously. One week later, the rats were perfused with ink-gelatin and euthanised and the femurs, tibias, and grafts were explanted. Samples were scanned using µCT, decalcified, incubated with phosphotungstic acid (PTA) for contrast enhancement, rescanned, and processed histologically. Results: Contrast-enhanced µCT displayed the course and branching of native bone vessels. Histologically, both central (-17%) and epiphyseal vessels (-58%) appeared smaller than in µCT scans. Hydroxyapatite cylinders were thoroughly vascularised but did not display bone formation. Grafts with a central artery had more (+58%) and smaller (-52%) vessel branches compared to grafts with a vein. Conclusions: We present a relatively inexpensive and easy-to-perform two-step method to analyse bone and vessels by µCT, suitable to assess a variety of bone-regenerative strategies.
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Trasplante Óseo , Huesos/irrigación sanguínea , Microtomografía por Rayos X/métodos , Animales , Medios de Contraste , Fémur/irrigación sanguínea , Gelatina , Tinta , Ácido Fosfotúngstico , Ratas , Tibia/irrigación sanguíneaRESUMEN
The first description of simultaneous pelvic and abdominal soft-tissue reconstruction with a giant lower limb fillet flap after hip exarticulation and open abdomen is presented. The unfortunate circumstances of a 67-year-old female patient are described leading to soft-tissue necrosis over a periprosthetic femur fracture and open abdomen after emergency implantation of an aortic bifemoral Y-prosthesis because of thrombotic obliteration of the aortic bifurcation. After removal of the hip prosthesis, the neurovascular pedicled myocutaneous fillet flap of the entire left leg was raised and folded proximally at the level of the exarticulated joint of the hip and set into the pelvic and abdominal defect. A giant pedicled neurovascular myocutaneous fillet flap raised over the entire lower extremity is a safe, effective, durable, and sensation-preserving treatment to reconstruct combined pelvic and abdominal soft-tissue defects.
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The wound healing promoting effect of negative wound pressure therapies (NPWT) takes place at the wound interface. The use of bioactive substances at this site represents a major research area for the development of future NPWT therapies. To assess wound healing kinetics in pressure ulcers treated by NPWT with or without the use of a thin interface membrane consisting of poly-N-acetyl glucosamine nanofibers (sNAG) a prospective randomized clinical trial was performed. The safety of the combination of NPWT and sNAG was also assessed in patients treated with antiplatelet drugs. In the performed study, the combination of NPWT and sNAG in 10 patients compared to NPWT alone in 10 patients promoted wound healing due to an improved contraction of the wound margins (p = 0.05) without a change in wound epithelization. In 6 patients treated with antiplatelet drugs no increased wound bleeding was observed in patients treated by NPWT and sNAG. In conclusion, the application of thin membranes of sNAG nanofibers at the wound interface using NPWT was safe and augmented the action of NPWT leading to improved wound healing due to a stimulation of wound contraction.
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Acetilglucosamina/uso terapéutico , Tejido de Granulación/patología , Nanofibras/uso terapéutico , Terapia de Presión Negativa para Heridas , Úlcera por Presión/terapia , Cicatrización de Heridas , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fotograbar , Úlcera por Presión/patología , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Autologous native cartilage from the nasal septum, ear, or rib is the standard material for surgical reconstruction of the nasal alar lobule after two-layer excision of non-melanoma skin cancer. We assessed whether engineered autologous cartilage grafts allow safe and functional alar lobule restoration. METHODS: In a first-in-human trial, we recruited five patients at the University Hospital Basel (Basel, Switzerland). To be eligible, patients had to be aged at least 18 years and have a two-layer defect (≥50% size of alar subunit) after excision of non-melanoma skin cancer on the alar lobule. Chondrocytes (isolated from a 6 mm cartilage biopsy sample from the nasal septum harvested under local anaesthesia during collection of tumour biopsy sample) were expanded, seeded, and cultured with autologous serum onto collagen type I and type III membranes in the course of 4 weeks. The resulting engineered cartilage grafts (25 mmâ×â25 mmâ×â2 mm) were shaped intra-operatively and implanted after tumour excision under paramedian forehead or nasolabial flaps, as in standard reconstruction with native cartilage. During flap refinement after 6 months, we took biopsy samples of repair tissues and histologically analysed them. The primary outcomes were safety and feasibility of the procedure, assessed 12 months after reconstruction. At least 1 year after implantation, when reconstruction is typically stabilised, we assessed patient satisfaction and functional outcomes (alar cutaneous sensibility, structural stability, and respiratory flow rate). FINDINGS: Between Dec 13, 2010, and Feb 6, 2012, we enrolled two women and three men aged 76-88 years. All engineered grafts contained a mixed hyaline and fibrous cartilage matrix. 6 months after implantation, reconstructed tissues displayed fibromuscular fatty structures typical of the alar lobule. After 1 year, all patients were satisfied with the aesthetic and functional outcomes and no adverse events had been recorded. Cutaneous sensibility and structural stability of the reconstructed area were clinically satisfactory, with adequate respiratory function. INTERPRETATION: Autologous nasal cartilage tissues can be engineered and clinically used for functional restoration of alar lobules. Engineered cartilage should now be assessed for other challenging facial reconstructions. FUNDING: Foundation of the Department of Surgery, University Hospital Basel; and Krebsliga beider Basel.
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Cartílagos Nasales/cirugía , Neoplasias Nasales/cirugía , Neoplasias Cutáneas/cirugía , Ingeniería de Tejidos/métodos , Anciano , Anciano de 80 o más Años , Condrocitos/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Procedimientos de Cirugía Plástica/métodosRESUMEN
Partial joint denervation or surgical neuroma therapy are alternative concepts to treat pain around the ankle joint that preserve joint function and relieve pain by interrupting neural pathways that transmit pain impulses from the joint to the brain. This review article summarizes the indication, anatomic background, operative techniques, and clinical results of joint denervation or neuroma surgery, which, although rarely reported and used, may provide a valuable alternative treatment in selected patients with neurogenous problems around the ankle.
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Articulación del Tobillo/inervación , Desnervación/métodos , Neuroma/cirugía , Manejo del Dolor/métodos , Dolor/cirugía , Humanos , Dolor/etiología , Resultado del TratamientoRESUMEN
Since the late 1960s, surgeons and scientists envisioned use of tissue engineering to provide an alternative treatment for tissue and organ damage by combining biological and synthetic components in such a way that a long-lasting repair was established. In addition to the treatment, the patient would also benefit from reduced donor site morbidity and operation time as compared with the standard procedures. Tremendous efforts in basic research have been done since the late 1960s to better understand chondrocyte biology and cartilage maturation and to fulfill the growing need for tissue-engineered cartilage in reconstructive, trauma, and orthopedic surgery. Starting from the first successful generation of engineered cartilaginous tissue, scientists strived to improve the properties of the cartilaginous constructs by characterizing different cell sources, modifying the environmental factors influencing cell expansion and differentiation and applying physical stimuli to modulate the mechanical properties of the construct. All these efforts have finally led to a clinical phase I trial to show the safety and feasibility of using tissue-engineered cartilage in reconstructive facial surgery. However, to bring tissue engineering into routine clinical applications and commercialize tissue-engineered grafts, further research is necessary to achieve a cost-effective, standardized, safe, and regulatory compliant process.
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Cartílago , Ensayos Clínicos Fase I como Asunto , Ingeniería de Tejidos , Animales , Reactores Biológicos , Técnicas de Cultivo de Célula , Desdiferenciación Celular , Condrocitos/citología , Ensayos Clínicos Fase I como Asunto/economía , Ensayos Clínicos Fase I como Asunto/legislación & jurisprudencia , Humanos , Suiza , Andamios del TejidoRESUMEN
Objective outcome analysis of nasal surgery remains difficult. Recently, evaluation of nasal shape following rhinosurgery shifted from two-dimensional evaluation to more sophisticated three-dimensional (3D) analysis techniques, including stereophotogrammetry, computed tomography, and 3D laser scanning. This article explores the feasibility of using 3D laser surface scanners as a tool for preoperative planning and quality control in rhinosurgery.
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Imagenología Tridimensional/métodos , Rayos Láser , Procedimientos Quírurgicos Nasales , Deformidades Adquiridas Nasales/patología , Deformidades Adquiridas Nasales/cirugía , Nariz/anatomía & histología , Adulto , Humanos , Procesamiento de Imagen Asistido por Computador/métodos , Imagenología Tridimensional/instrumentación , Masculino , Nariz/diagnóstico por imagen , Nariz/cirugía , Evaluación de Resultado en la Atención de Salud , Planificación de Atención al Paciente , Fotogrametría , Complicaciones Posoperatorias , Cuidados Preoperatorios , Control de Calidad , Reproducibilidad de los Resultados , Tomografía Computarizada por Rayos XRESUMEN
OBJECTIVE: To investigate if precultivation of human engineered nasal cartilage grafts of clinically relevant size would increase the suture retention strength at implantation and the tensile and bending stiffness 2 weeks after implantation. SUMMARY BACKGROUND INFORMATION: To be used for reconstruction of nasal cartilage defects, engineered grafts need to be reliably sutured at implantation and resist to bending/tension forces about 2 weeks after surgery, when fixation is typically removed. METHODS: Nasal septum chondrocytes from 4 donors were expanded for 2 passages and statically loaded on 15 x 5 x 2-mm size nonwoven meshes of esterified hyaluronan (Hyaff-11). Constructs were implanted for 2 weeks in nude mice between muscle fascia and subcutaneous tissue either directly after cell seeding or after 2 or 4 weeks of preculture in chondrogenic medium. Engineered tissues and native nasal cartilage were assessed histologically, biochemically, and biomechanically. RESULTS: Engineered constructs reproducibly developed with culture time into cartilaginous tissues with increasing content of glycosaminoglycans and collagen type II. Suture retention strength was significantly higher (3.6 +/- 2.2-fold) in 2-week precultured constructs than in freshly seeded meshes. Following in vivo implantation, tissues further developed and maintained the original scaffold size and shape. The bending stiffness was significantly higher (1.8 +/- 0.8-fold) if constructs were precultured for 2 weeks than if they were directly implanted, whereas tensile stiffness was close to native cartilage in all groups. CONCLUSION: In our experimental setup, preculture for 2 weeks was necessary to engineer nasal cartilage grafts with enhanced mechanical properties relevant for clinical use in facial reconstructive surgery.