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Characterisation of Biofilm of the Chronic Wounds (Biofilm Plaie)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519166
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Wounds Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : May 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients with chronic wounds Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing



Primary Outcome Measures :
  1. Clinical examination [ Time Frame: 1 month ]
  2. characterisation of biofilm by fluorescence microscopy and confocal [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519166


Locations
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France
Chu Montpellier
Montpellier, France, 34000
Institut Curie
Paris, France, 75005
Hopital Rothschild
Paris, France, 75012
Sponsors and Collaborators
Institut Curie
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02519166    
Other Study ID Numbers: 2012-02
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Wounds and Injuries