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INTRODUCTION: Outcome monitoring can identify fluctuations in healthcare. Cumulative sum (CUSUM) analysis can detect when mortality deviates from expected, allowing early intervention through targeted audit. We present a 10-year experience of the prospective use of CUSUM methodology in a regional burn centre. METHOD: Prospective outcome monitoring was conducted for all admissions to the intensive care unit between 2012 and 2022. The revised Baux score was used for mortality risk prediction. Risk-adjusted CUSUM charts tracked mortality against that predicted by the revised Baux score. Deviations from expected outcomes triggered detailed structured analysis. Learning outcomes were identified from internal and external governance groups. RESULTS: CUSUM analysis was triggered on eight occasions: one paediatric (excess deaths), six adult (four excess survivors, two excess deaths) and one elderly (excess survivors). Detailed analysis identified areas for continuous improvement and positive themes from excess survivors. CONCLUSION: The use of CUSUM as an early warning trigger stimulates assessment of practice and critical appraisal of factors contributing to unexpected mortality or survival. The revised Baux score at its foundation needs to be carefully considered but remains a valid model. One benefit is positive reinforcement of team cohesion and morale during periods of care excellence leading to excess survivors.
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Unidades de Queimados , Queimaduras , Unidades de Terapia Intensiva , Humanos , Unidades de Queimados/organização & administração , Queimaduras/mortalidade , Queimaduras/terapia , Estudos Prospectivos , Unidades de Terapia Intensiva/estatística & dados numéricos , Adulto , Avaliação de Resultados em Cuidados de Saúde , Sobreviventes/estatística & dados numéricos , Criança , Idoso , Masculino , Feminino , Medição de Risco/métodosRESUMO
INTRODUCTION: Advances in burns management have reduced mortality. Consequently, efficient resource management plays an increasingly important role in improving paediatric burns care. This study aims to assess the support requirements and outcomes of paediatric burns patients admitted to a burns centre intensive care unit in comparison to established benchmarks in burns care. METHOD: A retrospective review of burns patients under the age of 16 years old, admitted to a regional burns service intensive care unit between March 1998 and March 2016 was conducted. RESULTS: Our analysis included 234 patients, with the percentage of TBSA affected by burn injury ranging from 1.5% to 95.0%. The median (IQR) %TBSA was 20.0% (11.0-30.0), and the observed mortality rate was 2.6% (6/234). The median (IQR) length of stay was 0.7 days/%TBSA burn (0.4-1.2), 17.9% (41/229) required circulatory support and 2.6% (6/234) required renal replacement. Mortality correlated with smoke inhalation injury (P < 0.001), %TBSA burn (P = 0.049) and complications (P = 0.004) including infections (P = 0.013). CONCLUSIONS: Among children with burn injuries who require intensive care, the presence of inhalational injury and the diagnosis of infection are positively correlated with mortality. Understanding the requirements for organ support can facilitate a more effective allocation of resources within a burns service.
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Queimaduras , Unidades de Terapia Intensiva , Humanos , Criança , Adolescente , Tempo de Internação , Cuidados Críticos , Hospitalização , Unidades de Queimados , Estudos Retrospectivos , Queimaduras/complicaçõesRESUMO
Hypertrophic scars are a common complication of burn injuries, yet there are no medications to prevent their formation. During scar formation, resident fibroblasts are transformed to myofibroblasts which become resistant to apoptosis. Previously, we have shown that hydroxypyridone anti-fungals can inhibit transformation of fibroblasts, isolated from hypertrophic scars, to myofibroblasts. This study aimed to investigate if these drugs can also target myofibroblast persistence. Primary human dermal fibroblasts, derived from burn scar tissue, were exposed to transforming growth factor beta-1 (TGF-ß1) for 72 h to induce myofibroblast transformation. The cells were then incubated with three hydroxypyridone anti-fungals (ciclopirox, ciclopirox ethanolamine and piroctone olamine; 0.03-300 µM) for a further 72 h. The In-Cell ELISA method was utilised to quantify myofibroblast transformation by measuring alpha-smooth muscle actin (α-SMA) expression and DRAQ5 staining, to measure cell viability. TUNEL staining was utilised to assess if the drugs could induce apoptosis. When given to established myofibroblasts, the three hydroxypyridones did not reverse myofibroblast transformation, but instead elicited a concentration-dependent decrease in cell viability. TUNEL staining confirmed that the hydroxypyridone anti-fungals induced apoptosis in established myofibroblasts. This is the first study to show that hydroxypyridone anti-fungals are capable of inducing apoptosis in established myofibroblasts. Together with our previous results, we suggest that hydroxypyridone anti-fungals can prevent scar formation by preventing the formation of new myofibroblasts and by reducing the number of existing myofibroblasts.
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Cicatriz Hipertrófica , Miofibroblastos , Humanos , Miofibroblastos/patologia , Cicatriz Hipertrófica/metabolismo , Ciclopirox/metabolismo , Ciclopirox/uso terapêutico , Fibroblastos/metabolismo , Apoptose , Fator de Crescimento Transformador beta1/metabolismo , Actinas/metabolismo , Células Cultivadas , Diferenciação CelularRESUMO
Although hypertrophic scarring affects â¼91% of burn patients annually, there is no drug to prevent this common complication. Hypertrophic scars are a result of dysregulated wound healing, characterised by persistent myofibroblast transformation and the excessive accumulation of extracellular matrix (ECM). Due to the multi-mechanistic nature of the scarring process, target-based approaches for identifying novel drugs have failed. Primary human dermal fibroblasts, derived from burn scar tissue, were exposed to transforming growth factor-beta 1 (TGF-ß1) to induce myofibroblast transformation. A phenotypic screening assay, measuring alpha-smooth muscle actin (α-SMA) expression, was developed to screen 1,954 approved drugs. Drugs that elicited >80% inhibition of α-SMA expression, and >80% cell viability were progressed as candidate drugs. Anti-myofibroblast activity of the candidates was confirmed before investigating their effects on extracellular matrix (ECM) production and keratinocyte epithelial-mesenchymal transition (EMT). TGF-ß1 induced myofibroblast transformation in primary human dermal fibroblasts (Emax = >3 ng/mL). The assay was optimised and validated (Z' = 0.59), before screening 1,954 approved drugs. 90 drugs were identified as hits and hydroxypyridone anti-fungals selected for further testing. Concentration-response curves for these drugs confirmed their concentration-dependent anti-myofibroblast activity (IC50 = 1.4 - 16.7 µM). Hydroxypyridone anti-fungals were also found to successfully reduce ECM production and keratinocyte EMT. This is the first study to screen approved drugs in primary human dermal fibroblasts. Hydroxypyridone anti-fungals were found to prevent myofibroblast transformation, ECM production and keratinocyte EMT suggesting they could be repurposed to prevent hypertrophic scarring.
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Cicatriz Hipertrófica , Humanos , Cicatriz Hipertrófica/tratamento farmacológico , Cicatriz Hipertrófica/prevenção & controle , Cicatriz Hipertrófica/metabolismo , Fator de Crescimento Transformador beta1/metabolismo , Miofibroblastos/patologia , Fibroblastos , Actinas/metabolismo , Matriz Extracelular/metabolismo , Células CultivadasRESUMO
Vascularized composite allotransplantation has been successfully employed for burn reconstruction since 2003. However, its safety in this population has been questioned due to high levels of alloimmunization from burn care-related tissue exposures. To investigate this, a systematic review of vascularized composite allotransplantation employed for burn reconstruction was conducted, evaluating literature from January 2000 to September 2019. Articles containing vascularized composite allotransplantation, composite tissue allotransplantation, and burn reconstructive surgery were included; articles without published outcomes were excluded. Observational meta-analysis of pooled mortality and acute rejection episodes relative to allograft type (face vs extremity) and reconstruction type (burn vs non-burn) was performed. Twenty-four of the 63 identified articles met the criteria for inclusion, with 5 more articles added after secondary review. To date, 152 allotransplantations have been performed in 117 patients: 45 face transplants and 107 extremity transplants. Of these, 34 (22%) were performed for burn reconstruction in 25 patients (21%) with an overall higher 1-year mortality rate (12.0% vs 1.1%, P = .030). Of these deaths, 75% received three or more simultaneous allografts. Additionally, more episodes of acute rejection occurred compared to non-burn patients (4.4 vs 2.4, P = .035). Vascularized composite allotransplantation performed for burn reconstruction was found to be associated with a greater risk of 1-year mortality and nearly twice the number of episodes of acute rejection. Future studies should seek to identify unique risk factors of burn patients undergoing this operation and evaluate the relationship between antigenic burden and surgical outcomes.
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Queimaduras/cirurgia , Alotransplante de Tecidos Compostos Vascularizados , Rejeição de Enxerto , Sobrevivência de Enxerto , HumanosRESUMO
BACKGROUND: Subgroup analyses of two large EORTC adjuvant interferon-alpha2b (IFNα-2b) vs observation randomised trials demonstrated that a treatment benefit was observed only in patients with an ulcerated melanoma without palpable nodes (hazard ratio [HR] for recurrence-free survival [RFS] was 0.69). This was confirmed by a meta-analysis of 15 adjuvant IFN trials (HR: 0.79). PATIENTS AND METHODS: In the EORTC 18081 trial, sentinel node-negative stage II patients with an ulcerated primary melanoma were 1:1 randomised between pegylated (PEG)-IFNα-2b at 3 µg/kg/week subcutaneously and observation, for 2 years, or until disease recurrence or unacceptable toxicity in spite of dose adjustments to maintain an Eastern Cooperative Oncology Group performance status of 0 or 1. Main end-point was RFS. Secondary end-points included distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20). RESULTS: Between February 2013 and January 2017, only 112 patients were randomised, 56 in each arm. The trial was stopped early for lack of recruitment. At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively. DMFS was prolonged: HR: 0.39 (95% CI: 0.15-0.97), and the 3-year DMFS rate was 90.6% (95% CI: 78.9-96.0%) vs 76.4% (95% CI: 62.1-85.9%). One patient in the PEG-IFNα-2b group died compared with 4 in the observation group. Fifty-four patients started PEG-IFNα-2b treatment, 16 (29%) completed 2 years of treatment, 2 (4%) stopped due to recurrence, 23 (43%) due to toxicity and 14 (25%) due to other reasons. CONCLUSIONS: The EORTC 18081 PEG-IFNα-2b randomised trial, observed a similar HR (0.69) for RFS as the previous EORTC trials (0.69). In countries without access to new drugs, adjuvant (PEG)-IFNα-2b treatment is an option for patients with ulcerated melanomas without palpable nodes.
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Interferon alfa-2/administração & dosagem , Interferon-alfa/administração & dosagem , Melanoma/terapia , Polietilenoglicóis/administração & dosagem , Neoplasias Cutâneas/terapia , Úlcera Cutânea/terapia , Conduta Expectante , Adulto , Idoso , Quimioterapia Adjuvante , Terapia Combinada , Esquema de Medicação , Europa (Continente)/epidemiologia , Feminino , Humanos , Injeções Subcutâneas , Masculino , Oncologia/organização & administração , Melanoma/complicações , Melanoma/mortalidade , Melanoma/patologia , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Proteínas Recombinantes/administração & dosagem , Neoplasias Cutâneas/complicações , Neoplasias Cutâneas/mortalidade , Neoplasias Cutâneas/patologia , Úlcera Cutânea/complicações , Úlcera Cutânea/mortalidade , Úlcera Cutânea/patologia , Sociedades Médicas/organização & administração , Análise de Sobrevida , Conduta Expectante/métodosRESUMO
Clostridium septicum is an anaerobic, gram-positive bacillus known to cause myonecrosis, also known as gas gangrene, a life-threatening necrotizing soft tissue infection. Though it accounts for just 1 % of all infections attributable to Clostridia spp., C. septicum is a highly virulent and aggressive pathogen. Classic presentations of infection include bacteremia resulting in shock, myonecrosis, and vascular seeding. C. septicum-associated gas gangrene most commonly occurs in the setting of traumatic injury, but has also been reported in patients with colorectal malignancy, immunosuppression, neutropenia, and exceedingly rare in association with breast cancer. We report the case of a 56-year-old female patient with stage IV mixed lobar and ductal breast carcinoma with metastasis to the bone and liver, who presented with spontaneous C. septicum myonecrosis of the right hand. No prior traumatic injury was noted. Following amputation of the right forearm, antibiotic treatment, and multiorgan support, the patient passed following transition to palliative care. We hope to increase awareness of this relatively uncommon, though potentially deadly pathogen, as well as to discuss treatment options in patients infected with C. septicum.
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INTRODUCTION: Laser Doppler imaging (LDI) is the 'gold standard' tool for the assessment of burn depth. However, it is costly. The FLIR ONE is a novel, mobile-attached, thermal imaging camera used to assess burn wound temperature. This study compares the FLIR ONE and LDI in assessing burn depth and predicting healing times. METHODS: Forty-five adult patients with burn wounds, presenting at 1-5 days, were imaged with the FLIR ONE and LDI. Infected, chemical and electrical burns were excluded. Healing potential was determined by comparing wound and normal skin temperature for the FLIR ONE and blood flow changes with the LDI. Healing potential was categorised into wounds healing in less than and over 21 days. Pearson's test was used to determine the correlation between changes in wound temperature and healing potential. RESULTS: Percent total body surface area (%TBSA) was in the range of 0.5-45. FLIR demonstrated a sensitivity of 66.67% and specificity of 76.67% in predicting healing within 21 days, while LDI demonstrated a sensitivity of 93.33% and specificity of 40%. The FLIR ONE showed a significant difference in the mean temperature changes between burns that healed in less than (0.1933 ± 0.3554) and over 21 days (-1 ± 0.4329) (P = 0.04904). Pearson's test showed a significant correlation between the difference in wound and normal skin temperature with healing times (P = 0.04517). CONCLUSION: The inexpensive FLIR ONE shows a significant correlation between changes in wound temperature and healing times. It is useful in predicting healing within 21 days. However, evaporative cooling at the wound surface can lead to overprediction of healing times and overtreatment. LAY SUMMARY: Background Laser Doppler imaging is currently the main tool for burn depth assessment. It works by analysing the blood flow in a burn wound. Based on these findings, it can predict the depth of the burn injury and predict if it will heal in less than or over 21 days. The main problem is that it is costly. The FLIR ONE is a novel, mobile-attached, thermal imaging camera. It can be used to assess burn depth by comparing the temperature of the burn wound to the surrounding normal skin. This information can then be used to predict healing times into less than and over 21 days. The issue being explored The usefulness of the FLIR ONE in assessing burn depth and predicting healing time when compared to the LDI. How was the work conducted? Forty-five adult patients who sustained a burn injury within the last five days were imaged with both the FLIR ONE and LDI. Those with infected, electrical or chemical burns were excluded. Healing potential was determined by comparing the temperature of the burn wound with normal skin for the FLIR ONE and by changes in wound blood flow with the LDI. Healing potential was categorised into wounds healing in less than and over 21 days. The correlation between the temperature changes of the burn wound and healing time was evaluated for the FLIR ONE. What we learned from the study This study was able to demonstrate that the FLIR ONE showed a significant correlation between the temperature difference between the burn wound and normal skin with healing times. When compared with the LDI, the FLIR ONE was useful in predicting if a burn wound will heal in less than 21 days. The FLIR ONE has advantages over the LDI, it is low cost, portable and produces instantaneous images. Ultimately, this developing technology may increase access to higher standard burn care in centres where LDI is not affordable.
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OBJECTIVE: Acceleration of wound healing promises advantages for patients and caregivers in reducing the burden of disease, avoiding complications such as wound infections, and improving the long-term outcome. However, medicines that can accelerate wound healing are lacking. The objective of this open, blindly evaluated, randomized, multicenter phase III study was to compare intra-individually the efficacy and tolerability of Oleogel-S10 with fatty gauze dressing versus Octenilin® wound gel with fatty gauze dressing in accelerating the healing of superficial partial thickness burn wounds. METHODS: Acute superficial partial thickness burn wounds in adults caused by fire, heat burn or scalding were divided into 2 halves and randomly assigned to treatment with Oleogel-S10 or Octenilin® wound gel. Photos for observer-blinded analysis of wound healing were taken at each wound dressing change. Percentages of reepithelialization were assessed at defined intervals. Efficacy and tolerability were evaluated based on a 5-point Likert scale. RESULTS: Of 61 patients that were enrolled, 57 received the allocated intervention and 48 completed treatment. The percentage of patients with earlier wound healing was significantly higher for Oleogel-S10 (85.7%, n=30) compared to Octenilin® wound gel (14.3%, n=5, p<0.0001). The mean intra-individual difference in time to wound closure was -1.0 day in favour of Oleogel-S10 (-1.4, -0.6; 95% CI, p<0.0001). Most investigators (87.0%) and patients (84.8%) evaluated the efficacy of Oleogel-S10 to be 'better' or 'much better' than that of Octenilin® wound gel. Long-term outcome 3 months and 12 months post injury was improved in some patients. CONCLUSIONS: Oleogel-S10 (Episalvan) significantly accelerated the healing of superficial partial thickness burn wounds. It was safe and well tolerated.
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Queimaduras/tratamento farmacológico , Triterpenos/uso terapêutico , Cicatrização , Administração Cutânea , Adolescente , Adulto , Idoso , Bandagens , Feminino , Géis , Humanos , Masculino , Pessoa de Meia-Idade , Compostos Orgânicos/uso terapêutico , Reepitelização , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
INTRODUCTION: Burn injury in the elderly is associated with increased morbidity and mortality. It is not uncommon for biological age, or frailty, to differ from chronological age in this patient group and thus predicting individual clinical outcomes remains challenging. It has been previously shown that Rockwood's Clinical Frailty Scale, a global clinical measure of fitness and frailty in older people, can be a useful adjunct for predicting outcomes for elderly patients with burns >10% TBSA. We refine our previous work to investigate the impact of frailty on mortality of elderly patients with thermal burns of any size admitted to a burns unit and explore its role as a meaningful adjunct to the modified Baux score. METHODS: A retrospective analysis of case notes for all patients ≥65years admitted to our burns centre as an in-patient during an 8-year period was performed with standard demographics, burn injury parameters, length of stay and mortality outcomes collected. Measures of frailty were reviewed and statistically analysed to assess the impact of biological aging on clinical outcome in order to assess how the modified Baux score may be developed for the elderly using Frailty Score. RESULTS: 239 patients met the inclusion criteria. Mean age was 77years (range: 65-99years) and mean burn size was 14.46% TBSA (Range: 0.1-98% TBSA). The modified Baux and Frailty Score were both independent predictors of mortality (p<0.0001). Increased premorbid Frailty Score was associated with increased in-hospital (OR: 2.33, 95% CI: 1.63-3.34) and one-year mortality (OR: 3.13, 95% CI: 2.22-4.41) independent of burn size compared to the modified Baux Score (IHM OR: 1.09; 95% CI: 1.07-1.13, 1yr M: OR 1.08; 95% CI: 1.05-1.11). The Frailty Score (>3) was a much more sensitive predictor of one-year mortality (Sensitivity: 83.9%; Specificity: 66.4%) than the modified Baux (>97) (Sensitivity: 59.8%; Specificity: 82.9%). A Frailty Score >3 when combined with the modified Baux score demonstrated increased area under ROC curve for both in-hospital (0.89 (95% CI: 0.85-0.94); p=0.02) and one-year (0.88 (95% CI: 0.84-0.92); p=0.02) mortality when compared to the modified Baux alone. CONCLUSION: We demonstrate that Frailty Score can be used to independently predict in-hospital and one-year mortality for thermal burns of any size in the elderly admitted as an in-patient to a burns unit. We also find that the Frailty Score can be employed in combination with the modified Baux score to improve mortality prediction. We recommend that Frailty Score is integrated into the modified Baux score and used to focus burn care resources appropriately.
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Queimaduras/mortalidade , Fragilidade/epidemiologia , Mortalidade Hospitalar , Idoso , Idoso de 80 Anos ou mais , Superfície Corporal , Feminino , Hospitalização , Humanos , Modelos Logísticos , Masculino , Mortalidade , Prognóstico , Curva ROC , Estudos RetrospectivosRESUMO
Hand burns are unique in their functional, aesthetic and emotional impact on patients. Measuring the progress of a patient's ability to carry out essential and desired tasks, their emotional state, interaction with society as well as scar, pain and itch as their burn heals, has until now relied on the use of a combination of several different tools. We have developed a questionnaire specifically to address the multiple different aspects of the impact of a hand burn on a patient. This has been validated in a study of adult patients with hand burns in a UK unit, by a variety of psychometric tests. Ninety-four patients entered the study and questionnaires were completed over the course of a year at five time points. The total BHOT and DASH questionnaires completed at each time point was as follows: 86 before; 52 healed; 29 at 3 months; 31 at 6 months; 28 at 1 year, i.e. 226 DASH and 226 BHOT questionnaires in total. The questionnaire has been shown to have excellent reliability, criterion validity, construct validity, and responsiveness. The result is the Burnt Hand Outcome Tool (BHOT), a patient reported, quick and easy to use yet comprehensive questionnaire specifically for adult patients with burns to the hand.
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Atividades Cotidianas , Queimaduras/fisiopatologia , Traumatismos da Mão/fisiopatologia , Adolescente , Adulto , Idoso , Queimaduras/reabilitação , Cicatriz/fisiopatologia , Feminino , Traumatismos da Mão/reabilitação , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Reprodutibilidade dos Testes , Inquéritos e Questionários , Adulto JovemRESUMO
Background: Bevacizumab is a recombinant humanised monoclonal antibody to vascular endothelial growth factor shown to improve survival in advanced solid cancers. We evaluated the role of adjuvant bevacizumab in melanoma patients at high risk of recurrence. Patients and methods: Patients with resected AJCC stage IIB, IIC and III cutaneous melanoma were randomised to receive either adjuvant bevacizumab (7.5 mg/kg i.v. 3 weekly for 1 year) or standard observation. The primary end point was detection of an 8% difference in 5-year overall survival (OS) rate; secondary end points included disease-free interval (DFI) and distant metastasis-free interval (DMFI). Tumour and blood were analysed for prognostic and predictive markers. Results: Patients (n=1343) recruited between 2007 and 2012 were predominantly stage III (73%), with median age 56 years (range 18-88 years). With 6.4-year median follow-up, 515 (38%) patients had died [254 (38%) bevacizumab; 261 (39%) observation]; 707 (53%) patients had disease recurrence [336 (50%) bevacizumab, 371 (55%) observation]. OS at 5 years was 64% for both groups [hazard ratio (HR) 0.98; 95% confidence interval (CI) 0.82-1.16, P = 0.78). At 5 years, 51% were disease free on bevacizumab versus 45% on observation (HR 0.85; 95% CI 0.74-0.99, P = 0.03), 58% were distant metastasis free on bevacizumab versus 54% on observation (HR 0.91; 95% CI 0.78-1.07, P = 0.25). Forty four percent of 682 melanomas assessed had a BRAFV600 mutation. In the observation arm, BRAF mutant patients had a trend towards poorer OS compared with BRAF wild-type patients (P = 0.06). BRAF mutation positivity trended towards better OS with bevacizumab (P = 0.21). Conclusions: Adjuvant bevacizumab after resection of high-risk melanoma improves DFI, but not OS. BRAF mutation status may predict for poorer OS untreated and potential benefit from bevacizumab. Clinical Trial Information: ISRCTN 81261306; EudraCT Number: 2006-005505-64.
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Bevacizumab/administração & dosagem , Melanoma/terapia , Recidiva Local de Neoplasia/prevenção & controle , Neoplasias Cutâneas/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Adjuvante/métodos , Procedimentos Cirúrgicos Dermatológicos , Intervalo Livre de Doença , Esquema de Medicação , Feminino , Seguimentos , Humanos , Masculino , Melanoma/mortalidade , Melanoma/patologia , Pessoa de Meia-Idade , Mutação , Recidiva Local de Neoplasia/epidemiologia , Estadiamento de Neoplasias , Proteínas Proto-Oncogênicas B-raf/genética , Neoplasias Cutâneas/mortalidade , Neoplasias Cutâneas/patologia , Análise de Sobrevida , Fatores de Tempo , Conduta Expectante , Adulto JovemRESUMO
BACKGROUND: There is a lack of consensus regarding optimal surgical excision margins for primary cutaneous melanoma > 1 mm in Breslow thickness (BT). A narrower surgical margin is expected to be associated with lower morbidity, improved quality of life (QoL), and reduced cost. We report the results of a pilot international study (MelMarT) comparing a 1 versus 2-cm surgical margin for patients with primary melanoma > 1 mm in BT. METHODS: This phase III, multicentre trial [NCT02385214] administered by the Australia & New Zealand Medical Trials Group (ANZMTG 03.12) randomised patients with a primary cutaneous melanoma > 1 mm in BT to a 1 versus 2-cm wide excision margin to be performed with sentinel lymph node biopsy. Surgical closure technique was at the discretion of the treating surgeon. Patients' QoL was measured (FACT-M questionnaire) at baseline, 3, 6, and 12 months after randomisation. RESULTS: Between January 2015 and June 2016, 400 patients were randomised from 17 centres in 5 countries. A total of 377 patients were available for analysis. Primary melanomas were located on the trunk (56.9%), extremities (35.6%), and head and neck (7.4%). More patients in the 2-cm margin group required reconstruction (34.9 vs. 13.6%; p < 0.0001). There was an increased wound necrosis rate in the 2-cm arm (0.5 vs. 3.6%; p = 0.036). After 12 months' follow-up, no differences were noted in QoL between groups. DISCUSSION: This pilot study demonstrates the feasibility of a large international RCT to provide a definitive answer to the optimal excision margin for patients with intermediate- to high-risk primary cutaneous melanoma.
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Neoplasias de Cabeça e Pescoço/cirurgia , Margens de Excisão , Melanoma/cirurgia , Qualidade de Vida , Neoplasias Cutâneas/cirurgia , Pele/patologia , Adulto , Idoso , Procedimentos Cirúrgicos Dermatológicos/efeitos adversos , Extremidades , Estudos de Viabilidade , Feminino , Seguimentos , Neoplasias de Cabeça e Pescoço/patologia , Humanos , Masculino , Melanoma/patologia , Pessoa de Meia-Idade , Necrose/etiologia , Estadiamento de Neoplasias , Projetos Piloto , Complicações Pós-Operatórias/etiologia , Biópsia de Linfonodo Sentinela , Neoplasias Cutâneas/patologia , Transplante de Pele/efeitos adversos , Retalhos Cirúrgicos/efeitos adversos , TroncoRESUMO
OBJECTIVE: The aims of this study are: firstly, to investigate if admission to specialized burn critical care units leads to better clinical outcomes; secondly, to elucidate if the multidisciplinary critical care contributes to this superior outcome. METHODS: A multi-centre cohort analysis of a prospectively collected national database of 1759 adult burn patients admitted to 13 critical care units in England and Wales between 2005 and 2011. Units were contacted via telephone to establish frequency and constitution of daily ward rounds. Critical care units were categorized into 3 settings: specialized burns critical care units, generalized critical care units and 'visiting' critical care units. Multivariate logistic regression analysis and propensity dose-response analysis were used to calculate risk adjusted mortality. RESULTS: Multivariate logistic regression analysis shows that admission to a specialized burn critical care service is independently associated with significant survival benefit compared to generalized critical care unit (adjusted OR for in-hospital death 1.81, [95% CI, 1.24, 2.66]) and 'visiting' critical care services (adjusted OR for in-hospital death 2.24 [95% CI, 1.49, 3.38]). Further analysis using propensity dose-response analysis demonstrates that risk-adjusted in-hospital mortality rate decreased as the dose of multidisciplinary care increased, with an adjusted odds ratio of 1 (specialized burn critical care units), 1.81 (generalized critical care units) and 2.24 ('visiting' critical care units). CONCLUSIONS: Admission to a specialized burn critical care service is independently associated with significant survival benefit. This is, at least in part, due to care being provided by a fully integrated multidisciplinary team.
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Unidades de Queimados/estatística & dados numéricos , Queimaduras , Cuidados Críticos/estatística & dados numéricos , Prestação Integrada de Cuidados de Saúde/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Queimaduras/mortalidade , Queimaduras/terapia , Prestação Integrada de Cuidados de Saúde/normas , Feminino , Mortalidade Hospitalar , Humanos , Tempo de Internação/estatística & dados numéricos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Retrospectivos , Adulto JovemRESUMO
Hand burns represent a unique challenge to the burns team due to the intricate structure and unrivalled functional importance of the hand. The initial assessment and prognosis relies on consideration of the specific site involved as well as depth of the burn. We created a simple severity score that could be used by referring non-specialists and researchers alike. The Hand Burn Severity (HABS) score stratifies hand burns according to severity with a numerical value of between 0 (no burn) and 18 (most severe) per hand. Three independent assessors scored the photographs of 121 burned hands of 106 adult and paediatric patients, demonstrating excellent inter-rater reliability (r=0.91, p<0.0001 on testing with Lin's correlation coefficient). A significant relationship was shown between the HABS score and a reliable binary outcome of the requirement for surgical excision on Mann-Whitney U testing (U=152; Z=9.8; p=0.0001). A receiver operator characteristic (ROC) curve analysis found a cut off score of 5.5, indicating that those with a HABS score below 6 did not require an operation, whereas those with a score above 6 did. The HABS score was shown to be more sensitive and specific that assessment of burn depth alone. The HABS score is a simple to use tool to stratify severity at initial presentation of hand burns which will be useful when referring, and when reporting outcomes.