Characterisation of Biofilm of the Chronic Wounds | NCT02519166

Studies
Characterisation of Biofilm of the Chronic Wounds

NCT02519166

Sponsor

Institut Curie

Status

Completed

Last Update Posted

Nov 24, 2025Actual

Enrollment

130Actual

Phase

Not Applicable

Conditions

Chronic Wounds

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jul 28, 2015

First Submission Date that Met QC Criteria

Aug 6, 2015

First Posted Date

Aug 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with chronic wounds	Other		Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing	Biological		Patients with chronic wounds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical examination		1 month
characterisation of biofilm by fluorescence microscopy and confocal		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Montpellier		Montpellier		34000	France
Institut Curie