Characterisation of Biofilm of the Chronic Wounds

Not Applicable

Completed

• Conditions: Chronic Wounds

• Registration Number: NCT02519166
• Lead Sponsor: Institut Curie

Brief Summary

In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-08-06
• Last Update Submitted: 2015-08-06
• Study First Posted: 2015-08-10
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients with chronic wounds (period > 6 weeks) > 10 cm2
• Patient age >18 for the 3 French centres
• Patient participation in a follow-up program for treatment of their wound > 1 month
• Availability of patient information and written informed consent from them or their legal representative

Exclusion Criteria

• Patients unable to submit to medical follow-up in the trial due to geographical constraints etc
• Patients deprived of freedom or under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical examination	1 month
characterisation of biofilm by fluorescence microscopy and confocal	1 month

Trial Locations

Locations (3)

Chu Montpellier; 🇫🇷 Montpellier, France

Institut Curie; 🇫🇷 Paris, France

Hopital Rothschild; 🇫🇷 Paris, France