Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

Centre Hospitalier Universitaire de Nīmes10 enrolled

Overview

The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP.

The secondary objectives of this study are: * To estimate changes in several microbiological parameters over three time periods (before treatment, after applying the Metvixia® and after irradiation during a single TDP session). * Describe the evolution of the size and appearance of the wound 7d after the start of treatment * Describe the potential adverse events associated with a TDP session

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leg Ulcer

Interventions

Topical Dynamic Phototherapy (TDP)PROCEDURE

Metvixia cream is applied to the lesion (about 1mm thickness) and the treated zone is covered with an opaque dression for 3 hours. Any residual cream is removed an and the lesion immediately rinsed with saline solution when uncovering. One session (8 minutes) of phototherapy is then performed using an Altilite lamp in accordance with HAS (haute authorité de santé) recommendations.

Metvixia creamDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient correctly informed concerning study implementation, objectives, constraints and patient rights * The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient presents with one or more leg ulcers (artieral, venous or mixed) * Afebrile patient without periulcerous erythema and who does not require antibiotic therapy * Patient who has not received antibiotic treatment during the last 7 Days Nota bene: Patients with multiple ulcers at different stages will be included for the wound corresponding to the highest stage. If the patient has multiple ulcers atn the same stage, the deepest wound will be considered. Exclusion Criteria: * The patient is participating in another interventional study, has participated in another interventional study with the past 3 months, or is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * The patient has a contraindication for a treatment used in this study * Patient with an infected leg ulcer treated with antibiotics * Patients on curative anticoagulation

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample

Time frame: Baseline (Day 0)

The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample

Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy

The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample

Time frame: Day 0: immediately after phototherapy

Secondary Outcomes

The percentage of commensal bacteria among bacteria species isolated per sample

Time frame: Baseline (Day 0)

The percentage of commensal bacteria among bacteria species isolated per sample

Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy

The percentage of commensal bacteria among bacteria species isolated per sample

Time frame: Day 0: immediately after phototherapy

The number of bacteria taxa detected per sample

Time frame: Baseline (Day 0)

The number of bacteria taxa detected per sample

Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy

The number of bacteria taxa detected per sample

Time frame: Day 0: immediately after phototherapy

The diversity of bacteria taxa detected per sample (Shannon's H with log2)

Data from ClinicalTrials.gov

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