Utility of Samples in Bacteriological Prospective Series of Ulcers Leg Infected Clinically
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of change of treatment response
研究概览
简要总结
Leg ulcers are defined as wounds lasting for more than a month. They would receive 0.2% of the population of Western countries. In Europe, the cost per episode of leg ulcers is estimated at 6650 euros (10 000 euros for a foot ulcer). The cost of treatment of wounds would be 2 to 4% of the health budget. Infection is the most common complication of chronic wounds: in most cases, it results in delayed healing, at most, it can result in amputation or serious general complications Bacterial contamination of ulcers is constant. Over time for over 25 years, various studies have shown about relatively identical results. The bacteria are present in over 90% of the etiology of venous leg ulcers. These bacteria are divided into four most common classes: Staphylococcus aureus, Enterococcus, Streptococcus, Pseudomonas. The bacterial ecology changes over time. Indeed Staphylococcus aureus appears first, while the Pseudomonas is associated with ulcers lasting for several months. Anaerobic more difficult to find, are found in 30% of cases Cohabitation between leg ulcers and bacteria often without clinical consequence: These are the stages of infection and colonization.
The infection is related to the proliferation of bacteria and their invasion into the skin, by increasing their virulence (virulence genes acquisition). The increase in the number of bacteria and the multiplicity of bacterial genera are one reason for the increased virulence of bacteria. When bacteria proliferate, because the host defenses are inadequate, or because there is a vascular disease which promotes the proliferation, clinical signs appear
详细描述
RESEARCH PROJECT Vascular medicine at St Joseph, the management of chronic wounds concerns 80% of hospitalized patients, more than 1,000 patients per year. The reason for hospitalization of these patients outside of revascularization gestures, often performing a skin graft. The existence of an infection of the ulcer on arrival in the service is not a cons-indication for transplant, but will delay it until the signs of infection are brought under control. This scenario is common. The Medical Information department on six months, noted over 100 patients coded "leg ulcers" principal diagnosis and "soft tissue infections" secondary diagnosis.
The importance of this recruitment and the lack of recommendations for the management of these patients justifies the completion of a clinical and microbiological work Until recent months, at the request of Microbiology, bacteriological referred to biopsy was performed first line when suspected of being infected ulcer. After reading the literature, and because of the invasive nature of this gesture, the evaluation of biopsy compared to the swab in a large patient population seems to necessary to the investigators
The proposed work is randomized blinded for microbiological and observational part for the clinical part, on a prospective series of consecutive carriers of infected leg ulcer patients, regardless of the etiology of leg ulcers, excluding dermohypodermitis complicating acute bacterial leg ulcers, with several objectives:
PRIMARY OBJECTIVE Demonstrate the non-inferiority of the swab compared to biopsy in the management of patients hospitalized for infected leg ulcer
two situations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman over 18 years
- •Hospitalized for a leg ulcer whatever the etiology, vascular medicine
- •Having clinical criteria and / or biological that suggest infection
- •No opposition to participate in the study
排除标准
- •Arterial ulcers requiring revascularization (digging ulcers, tendon or bone exposure, necrosis, toe pressure <50 mmHg)
- •Ulcers cancer
- •Ulcers with acute bacterial cellulitis: large painful acute red leg
- •Poor understanding of the French language
- •Major hearing impairment
- •Severe cognitive or psychiatric disorders
研究组 & 干预措施
a swab according to the method of Levine
干预措施: a swab according to the method of Levine (Biological)
Bacteriological referred to biopsy
干预措施: Bacteriological referred to biopsy (Biological)
结局指标
主要结局
Assessment of change of treatment response
时间窗: Hour 24 and hour 72
Disappearance of at least two signs of infection from the following: 1. abundant exudate (dry coverage compresses) 2. local heat 3. smelly character 4. 50% decrease of erythema ulcerous perished And reduction in pain of at least two points on the digital scale
Assessement of the infection statue by medical examination
时间窗: Day-1 and the Day 1 after release
The physician will answer on the CRF (Clinical Report Form) by: Yes or no
次要结局
- Assessment of change of the ulcer aspect(At Hour 0 and Hour 48)