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

NCT ID: NCT04541394

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2022-11-30

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.

Conditions

Infection, Surgical Site

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MolecuLight group

Patients with infected wounds received MolecuLight photography during debridement operation to evaluate the adequacy of remission of infected biofilm and facilitate wound healing

Group Type: EXPERIMENTAL

MolecuLight

Intervention Type: DEVICE

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.

Control group

Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang shun cheng

Director of Wound Care Center and Department of Plastic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shun Cheng Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

Shuang Ho Hospital First Medical Building

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shun Cheng Chang, MD

Role: CONTACT

csc901515@gmail.com

+88622490088 ext. 2365

Jung Hsuan Chang, Bachelor

Role: CONTACT

16231@s.tmu.edu.tw

+886910916869

Other Identifiers

N202006059

Identifier Type: -

Identifier Source: org_study_id