Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement

Taipei Medical University

Status: Unknown

Conditions: Infection, Surgical Site

Treatments: Device: MolecuLight

Study type: Interventional

Funder types: Other

Identifiers

NCT04541394

N202006059

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with wounds that present obvious symptoms or/and signs of infection, and chronic wounds that have failed to heal or improve for 14 days (Chronic wounds are often complicated or caused by wound infection)
• Patients that are scheduled for surgical treatment for the wound
• Patients that are older than (including) 20 years and younger than (including) 85 years.
• Wounds with a size larger than 1x1 cm2

Exclusion criteria

• Wounds that heal within 14 days.
• Patient is unable to continue further surgical treatment due to any reason
• The wound site is amputated
• Patient refuses further surgical treatment
• The patient has an active malignancy currently under treatment
• Patient is immunocompromised or currently under systemic steroid treatment
• The wound had been treated by radiation
• The patient refuses to participate in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

MolecuLight group

Experimental group

Description:

Patients with infected wounds received MolecuLight photography during debridement operation to evaluate the adequacy of remission of infected biofilm and facilitate wound healing

Treatment:

Device: MolecuLight

Control group

No Intervention group

Description:

Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds