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

NCT04541394 | Unknown FDA Device

• 1 other identifier: N202006059
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Duration of wound healing

  Time of complete epithelialization without drainage

  Time of complete epithelialization without drainage

Secondary Outcomes (3)

• Incidence of surgical complications

  8 weeks postoperatively

• Antibiotic use

  8 weeks postoperatively

• Duration of antibiotic use

  8 weeks postoperatively

Study Arms (2)

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

Device: MolecuLight

Control group

NO INTERVENTION

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

Interventions

MolecuLight 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.

MolecuLight group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital First Medical Building

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shun Cheng Chang, MD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shun Cheng Chang, MD

CONTACT

+88622490088; csc901515@gmail.com

Jung Hsuan Chang, Bachelor

CONTACT

+886910916869; 16231@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Wound Care Center and Department of Plastic Surgery

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: September 9, 2020
• Study Start: February 17, 2021
• Primary Completion: July 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

TW (1)