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NCT02519166 Clinical Trial

Characterisation of Biofilm of the Chronic Wounds

Chronic Wounds Clinical Trial

— Biofilm Plaie  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02519166
Other study ID # 2012-02
Secondary ID
Status Completed
Phase N/A
First received July 28, 2015
Last updated August 6, 2015
Start date May 2012
Est. completion date May 2015

Study information
Verified date July 2015
Source Institut Curie
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Chu Montpellier Montpellier
France Hopital Rothschild Paris
France Institut Curie Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical examination 1 month No
Primary characterisation of biofilm by fluorescence microscopy and confocal 1 month No
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