Clinical trial NCT04541394: Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
Official title: Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection, Surgical Site
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of residual bacterial light spots
timeFrame: Immediately after each debridement within surgery
measure: Numbers of Re-debridement
timeFrame: Immediately after each surgery
measure: Duration of wound healing
timeFrame: Time of complete epithelialization without drainage
Secondary outcomes:
measure: Incidence of surgical complications
timeFrame: 8 weeks postoperatively
measure: Antibiotic use
timeFrame: 8 weeks postoperatively
measure: Duration of antibiotic use
timeFrame: 8 weeks postoperatively
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital First Medical Building
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Shun Cheng Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: