RESUMO
BACKGROUND: Partial thickness burns are painful, difficult to manage and can have a negative effect on quality of life through scarring, permanent disfigurement and loss of function. The aim of burn treatment in partial thickness burns is to save lives, stimulate wound healing by creating an optimumly moist wound environment, to have debriding and analgesic effects, protect the wound from infection and be convenient for the patient and caregivers. However, there is no consensus on the optimal treatment of partial thickness wounds. Flaminal® and Flamazine® are two standard treatment options that provide the above mentioned properties in burn treatment. Nevertheless, no randomized controlled study has yet compared these two common treatment modalities in partial thickness burns. Thus, the aim of this study is to evaluate the clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns. METHODS/DESIGN: In this two-arm open multi-center randomized controlled trial, 90 patients will be randomized between Flaminal® and Flamazine® and followed for 12 months. The study population will consist of competent or temporarily non-competent (because of sedation and/or intubation) patients, 18 years of age or older, with acute partial thickness burns and a total body surface area (TBSA) of less than 30 %. The main study outcome is time to complete re-epithelialization (greater than 95 %). Secondary outcome measures include need for grafting, wound colonization/infection, number of dressing changes, pain and anxiety, scar formation, health-related quality of life (HRQoL), and costs. DISCUSSION: This study will contribute to the optimal treatment of patients with partial thickness burn wounds and will provide evidence on the (cost-)effectiveness and quality of life of Flaminal® versus Flamazine® in the treatment of partial thickness burns. TRIAL REGISTRATION: Netherlands Trial Register NTR4486 , registered on 2 April 2014.
Assuntos
Alginatos/economia , Alginatos/uso terapêutico , Anti-Infecciosos Locais/economia , Anti-Infecciosos Locais/uso terapêutico , Queimaduras/tratamento farmacológico , Queimaduras/economia , Custos de Medicamentos , Glucose Oxidase/economia , Glucose Oxidase/uso terapêutico , Lactoperoxidase/economia , Lactoperoxidase/uso terapêutico , Polietilenoglicóis/economia , Polietilenoglicóis/uso terapêutico , Qualidade de Vida , Sulfadiazina de Prata/economia , Sulfadiazina de Prata/uso terapêutico , Pele/efeitos dos fármacos , Cicatrização/efeitos dos fármacos , Alginatos/efeitos adversos , Anti-Infecciosos Locais/efeitos adversos , Queimaduras/complicações , Queimaduras/psicologia , Cicatriz/etiologia , Cicatriz/terapia , Protocolos Clínicos , Análise Custo-Benefício , Combinação de Medicamentos , Glucose Oxidase/efeitos adversos , Humanos , Lactoperoxidase/efeitos adversos , Países Baixos , Dor/etiologia , Polietilenoglicóis/efeitos adversos , Reepitelização/efeitos dos fármacos , Projetos de Pesquisa , Sulfadiazina de Prata/efeitos adversos , Pele/patologia , Transplante de Pele , Fatores de Tempo , Resultado do Tratamento , Infecção dos Ferimentos/microbiologia , Infecção dos Ferimentos/terapiaRESUMO
OBJECTIVES: Non-operative management has become the treatment of choice in the majority of liver injuries. The aim of this study was to assess the changes in primary treatment and outcomes in a single Dutch Level 1 trauma centre with wide experience in angio-embolisation (AE). METHODS: The prospective trauma registry was retrospectively analysed for 7-year periods before (Period 1) and after (Period 2) the introduction of AE. The primary outcome was the failure rate of primary treatment defined as liver injury-related death or re-bleeding requiring radiologic or operative (re)interventions. Secondary outcomes were liver injury-related intra-abdominal complications. RESULTS: Despite an increase in high-grade liver injuries, the incidence of primary non-operative management more than doubled over the two periods, from 33% (20 of 61 cases) in Period 1 to 72% (84 of 116 cases) in Period 2 (P < 0.001). The failure rate of primary treatment in Period 1 was 18% (11/61), compared with 11% (13/116) in Period 2 (P= 0.21). Complication rates were 23% (14/61) and 16% (18/116) in Periods 1 and 2, respectively (P= 0.22). Liver-related mortality rates were 10% (6/61) and 3% (4/116) in Periods 1 and 2, respectively (P= 0.095). The increase in the frequency of non-operative management was even higher in high-grade injuries, in which outcomes were improved. In high-grade injuries in Periods 1 and 2, failure rates decreased from 45% (9/20) to 20% (11/55) (P= 0.041), liver-related mortality decreased from 30% (6/20) to 7% (4/55) (P= 0.019) and complication rates fell from 60% (12/20) to 27% (15/55) (P= 0.014). Liver infarction or necrosis and abscess formation seemed to occur more frequently with AE. CONCLUSIONS: Overall, liver-related mortality, treatment failure and complication rates remained constant despite an increase in non-operative management. However, in high-grade injuries outcomes improved after the introduction of AE.