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

Infection, Surgical Site Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541394
• Other study ID #: N202006059
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2021
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Shun Cheng Chang, MD
• Phone: +88622490088
• Email: csc901515[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection, Surgical Site
• Surgical Wound Infection

Intervention

Device:
• MolecuLight
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.

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital First Medical Building	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Duration of wound healing	Time of complete epithelialization without drainage	Time of complete epithelialization without drainage
Secondary	Incidence of surgical complications	Incidence of wound bleeding, infection and necrosis after debridement	8 weeks postoperatively
Secondary	Antibiotic use	The amount (regimen and dosage)	8 weeks postoperatively
Secondary	Duration of antibiotic use		8 weeks postoperatively