Characterisation of Biofilm of the Chronic Wounds (Biofilm Plaie)

Institut Curie

Status: Completed

Conditions: Chronic Wounds

Treatments: Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing

Study type: Interventional

Funder types: Other

Identifiers

NCT02519166

IC 2012-02

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Patients with chronic wounds

Other group

Treatment:

Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing