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

NCT02889926 | Unknown DMC

• 1 other identifier: ULCERINFECTE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Assessment of change of treatment response

  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

  Hour 24 and hour 72

• Assessement of the infection statue by medical examination

  The physician will answer on the CRF (Clinical Report Form) by: Yes or no

  Day-1 and the Day 1 after release

Secondary Outcomes (1)

• Assessment of change of the ulcer aspect

  At Hour 0 and Hour 48

Study Arms (2)

a swab according to the method of Levine

EXPERIMENTAL

Biological: a swab according to the method of Levine

Bacteriological referred to biopsy

EXPERIMENTAL

Biological: Bacteriological referred to biopsy

Interventions

a swab according to the method of Levine BIOLOGICAL

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.

a swab according to the method of Levine

Bacteriological referred to biopsy BIOLOGICAL

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

Bacteriological referred to biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Isabelle LAZARETH, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 7, 2016
• Study Start: February 10, 2017
• Primary Completion: January 18, 2019
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)