Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
Primary Purpose
Infection, Surgical Site
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
MolecuLight
Sponsored by
About this trial
This is an interventional treatment trial for Infection, Surgical Site
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
Sites / Locations
- Shuang Ho Hospital First Medical BuildingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MolecuLight group
Control group
Arm Description
Patients with infected wounds received MolecuLight photography during debridement operation to evaluate the adequacy of remission of infected biofilm and facilitate wound healing
Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds
Outcomes
Primary Outcome Measures
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)
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
Duration of wound healing
Time of complete epithelialization without drainage
Secondary Outcome Measures
Incidence of surgical complications
Incidence of wound bleeding, infection and necrosis after debridement
Antibiotic use
The amount (regimen and dosage)
Duration of antibiotic use
Full Information
NCT ID
NCT04541394
First Posted
August 11, 2020
Last Updated
March 8, 2021
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04541394
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Surgical Site
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MolecuLight group
Arm Type
Experimental
Arm Description
Patients with infected wounds received MolecuLight photography during debridement operation to evaluate the adequacy of remission of infected biofilm and facilitate wound healing
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds
Intervention Type
Device
Intervention Name(s)
MolecuLight
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of residual bacterial light spots
Description
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)
Time Frame
Immediately after each debridement within surgery
Title
Numbers of Re-debridement
Description
If the bacterial shinny area after debridement > 10% wound area, the debridement will be performed again until < 10% residual bacterial shinny area
Time Frame
Immediately after each surgery
Title
Duration of wound healing
Description
Time of complete epithelialization without drainage
Time Frame
Time of complete epithelialization without drainage
Secondary Outcome Measure Information:
Title
Incidence of surgical complications
Description
Incidence of wound bleeding, infection and necrosis after debridement
Time Frame
8 weeks postoperatively
Title
Antibiotic use
Description
The amount (regimen and dosage)
Time Frame
8 weeks postoperatively
Title
Duration of antibiotic use
Time Frame
8 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shun Cheng Chang, MD
Phone
+88622490088
Ext
2365
Email
csc901515@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Hsuan Chang, Bachelor
Phone
+886910916869
Email
16231@s.tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shun Cheng Chang, MD
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shuang Ho Hospital First Medical Building
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
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