Infection, Surgical SiteNCT04541394
Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
A study testing MolecuLight in people with Infection, Surgical Site, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Infection, Surgical Site
- What is being tested?
- MolecuLight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Feb 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shuang Ho Hospital First Medical Building
New Taipei City
About this study
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.
- Conditions
- Infection, Surgical Site
- Being tested
- MolecuLight
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolecuLightDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MolecuLight group | Experimental | Patients with infected wounds received MolecuLight photography during debridement operation to evaluate the adequacy of remission of infected biofilm and facilitate wound healing Receives: Device: MolecuLight |
| Control group | No intervention | Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Immediately after each surgery
Duration of wound healing
Time of complete epithelialization without drainage
Measured: Time of complete epithelialization without drainage
Secondary outcomes (3)
Incidence of surgical complications
Incidence of wound bleeding, infection and necrosis after debridement
Measured: 8 weeks postoperatively
Antibiotic use
The amount (regimen and dosage)
Measured: 8 weeks postoperatively
Duration of antibiotic use
Measured: 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start17 Feb 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Surgical SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang shun cheng, Taipei Medical University Shuang Ho Hospital
- Investigators
- Shun Cheng Chang, MD, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541394
- Sponsor's protocol ID
- N202006059
- Status last verified
- Mar 2021
- First submitted
- 11 Aug 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
- ClinicalTrials.gov ID
- NCT04541394
- Acronym / sponsor ID
- N202006059
- Conditions
- Infection, Surgical Site
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MolecuLight group | Experimental | Device: MolecuLightPatients with infected wounds received MolecuLight photography during debridement operation to evaluate the adequacy of remission of infected biofilm and facilitate wound healing |
| Control group | No intervention | –Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MolecuLightMolecuLight 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. | Device | MolecuLight group |
Primary outcome
Percentage of residual bacterial light spots
Time frame: 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
Time frame: 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 frame: Time of complete epithelialization without drainage
Time of complete epithelialization without drainage
3 secondary outcomes
Incidence of surgical complications
Time frame: 8 weeks postoperatively
Antibiotic use
Time frame: 8 weeks postoperatively
Duration of antibiotic use
Time frame: 8 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shun Cheng Chang, MD principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MolecuLight in people with Infection, Surgical Site, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shun Cheng Chang, MD (+88622490088 ext. 2365, csc901515@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of residual bacterial light spots (time frame: Immediately after each debridement within surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.