Infection, Surgical Site
Conditions
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.
Interventions
DEVICEMolecuLight
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.
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of residual bacterial light spots | Immediately after each debridement within surgery | 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) |
| Numbers of Re-debridement | Immediately after each surgery | If the bacterial shinny area after debridement \> 10% wound area, the debridement will be performed again until \< 10% residual bacterial shinny area |
| Duration of wound healing | Time of complete epithelialization without drainage | Time of complete epithelialization without drainage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical complications | 8 weeks postoperatively | Incidence of wound bleeding, infection and necrosis after debridement |
| Antibiotic use | 8 weeks postoperatively | The amount (regimen and dosage) |
| Duration of antibiotic use | 8 weeks postoperatively | — |
Countries
Taiwan
Contacts
Primary ContactShun Cheng Chang, MD
Backup ContactJung Hsuan Chang, Bachelor
Outcome results
None listed