Viewing Study NCT04541394


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Study NCT ID: NCT04541394
Status: UNKNOWN
Last Update Posted: 2021-03-09
First Post: 2020-08-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
Sponsor: Taipei Medical University Shuang Ho Hospital
Organization:

Study Overview

Official Title: Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
Status: UNKNOWN
Status Verified Date: 2021-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: MolecuLight is a device that utilizes a special light which, when used on wounds, helps identify the regions which pathogenic bacterial counts are the highest. The device applies 405nm violet light which is harmless to the human tissue. When specific components in bacteria catches up the light, a photoluminescent reaction is triggered and the fluorescence light is caught by the camera on this device in real time.

When treating an infected wound which requires debridement and/or reconstruction, traditionally surgeons rely on many clinical clues to judge the severity and region of infection. However, these clues, such as lab data, vital signs, bacterial culture growth, or infection symptoms/signs, are usually indirect and also require several days to be fully interpretated.

The advantage of MolecuLight is its simple, direct, real-time, and flexible application, which is very important and valuable when treating an infected wound. We aim to add this device to our routines and see if the treatment course for these wounds can be more rapid and effective, and also utilize the countless potential of immediate bacterial identification in numerous aspects of our work.
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: