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

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.

Study Overview

• Status: Recruiting
• Conditions: Infection, Surgical Site
• Intervention / Treatment: Device: MolecuLight

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shun Cheng Chang, MD; Phone Number: 2365 +88622490088; Email: csc901515@gmail.com
• Study Contact Backup: Name: Jung Hsuan Chang, Bachelor; Phone Number: +886910916869; Email: 16231@s.tmu.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Recruiting
    • Shuang Ho Hospital First Medical Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MolecuLight group; Patients with infected wounds received MolecuLight photography during debridement operation to evaluate the adequacy of remission of infected biofilm and facilitate wound healing	Device: MolecuLight; 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.
No Intervention: Control group; Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of residual bacterial light spots	The percentage of residual bacterial light spots. After each debridement, we use MolecuLight to evaluate the residual shinny area (post-debridement shinny area/pre-debridement shinny area)	Immediately after each debridement within surgery
Numbers of Re-debridement	If the bacterial shinny area after debridement > 10% wound area, the debridement will be performed again until < 10% residual bacterial shinny area	Immediately after each surgery
Duration of wound healing	Time of complete epithelialization without drainage	Time of complete epithelialization without drainage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of surgical complications	Incidence of wound bleeding, infection and necrosis after debridement	8 weeks postoperatively
Antibiotic use	The amount (regimen and dosage)	8 weeks postoperatively
Duration of antibiotic use		8 weeks postoperatively

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Shun Cheng Chang, MD, Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection
• Other Study ID Numbers: N202006059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes