Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-02 @ 8:55 PM
Study NCT ID:
NCT04541394
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of residual bacterial light spots', 'timeFrame': 'Immediately after each debridement within surgery', '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)'}, {'measure': 'Numbers of Re-debridement', 'timeFrame': 'Immediately after each surgery', 'description': 'If the bacterial shinny area after debridement \\> 10% wound area, the debridement will be performed again until \\< 10% residual bacterial shinny area'}, {'measure': 'Duration of wound healing', 'timeFrame': 'Time of complete epithelialization without drainage', 'description': 'Time of complete epithelialization without drainage'}], 'secondaryOutcomes': [{'measure': 'Incidence of surgical complications', 'timeFrame': '8 weeks postoperatively', 'description': 'Incidence of wound bleeding, infection and necrosis after debridement'}, {'measure': 'Antibiotic use', 'timeFrame': '8 weeks postoperatively', 'description': 'The amount (regimen and dosage)'}, {'measure': 'Duration of antibiotic use', 'timeFrame': '8 weeks postoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Infection, Surgical Site']}, 'descriptionModule': {'briefSummary': '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.\n\nWhen 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Patients that are scheduled for surgical treatment for the wound\n* Patients that are older than (including) 20 years and younger than (including) 85 years.\n* Wounds with a size larger than 1x1 cm2\n\nExclusion Criteria:\n\n* Wounds that heal within 14 days.\n* Patient is unable to continue further surgical treatment due to any reason\n* The wound site is amputated\n* Patient refuses further surgical treatment\n* The patient has an active malignancy currently under treatment\n* Patient is immunocompromised or currently under systemic steroid treatment\n* The wound had been treated by radiation\n* The patient refuses to participate in this study'}, 'identificationModule': {'nctId': 'NCT04541394', 'briefTitle': 'Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement', 'orgStudyIdInfo': {'id': 'N202006059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MolecuLight group', 'description': 'Patients with infected wounds received MolecuLight photography during debridement operation to evaluate the adequacy of remission of infected biofilm and facilitate wound healing', 'interventionNames': ['Device: MolecuLight']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "Patients with infected wounds received debridement operation by surgeon's clinical experiences to decide the extension of wounds"}], 'interventions': [{'name': 'MolecuLight', 'type': 'DEVICE', '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.', 'armGroupLabels': ['MolecuLight group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Shuang Ho Hospital First Medical Building', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Shun Cheng Chang, MD', 'role': 'CONTACT', 'email': 'csc901515@gmail.com', 'phone': '+88622490088', 'phoneExt': '2365'}, {'name': 'Jung Hsuan Chang, Bachelor', 'role': 'CONTACT', 'email': '16231@s.tmu.edu.tw', 'phone': '+886910916869'}], 'overallOfficials': [{'name': 'Shun Cheng Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University Shuang Ho Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Wound Care Center and Department of Plastic Surgery', 'investigatorFullName': 'Chang shun cheng', 'investigatorAffiliation': 'Taipei Medical University Shuang Ho Hospital'}}}}