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

NCT02889926 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-04-27

No results posted yet for this study

Summary

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

Conditions

  • Leg Ulcer

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Isabelle LAZARETH, MD · Fondation Hôpital Saint-Joseph

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2019-01-18
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889926 on ClinicalTrials.gov