Clinical trial

Utility of Samples in Bacteriological Prospective Series of Ulcers Leg Infected Clinically

Name
ULCERINFECTE
Description
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
Trial arms
Trial start
2017-02-10
Estimated PCD
2019-01-18
Trial end
2023-12-31
Status
Active (not recruiting)
Treatment
a swab according to the method of Levine
A swab according to the method of Levine: choose the pathological area by pressing the swab over the area, with a rotation supported on at least 1 cm² for 5 seconds, to well up from the liquid.
Arms:
a swab according to the method of Levine
Bacteriological referred to biopsy
Bacteriological referred to biopsy: (This is the hole protocol) Choose the pathological area, debridement of the wound to the pad and a scalpel, cleaning with betadine followed by rinsing with saline, local anesthesia with xylocaine, 6 mm punch for drawing a carrot, put into a sterile container
Arms:
Bacteriological referred to biopsy
Size
100
Primary endpoint
Assessment of change of treatment response
Hour 24 and hour 72
Assessement of the infection statue by medical examination
Day-1 and the Day 1 after release
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-04-27

1 organization

2 products

1 indication

Indication
Leg Ulcer