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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infection, Surgical Site

Intervention / Treatment
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* Device: MolecuLight


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MolecuLight group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds | |

What is the study measuring?
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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 |