NCT02392390

Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Leg Ulcer

Interventions

Type	Name	Description
PROCEDURE	Topical Dynamic Phototherapy (TDP)	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.
DRUG	Metvixia cream

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-03-19
• Last updated: 2016-04-07

Locations

1 site across 1 country: France