Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04342767
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2020-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bacterial Bioburden', 'timeFrame': 'Before and After Mechanical debridement within 1 hour', 'description': 'The reduction in bacterial bioburden following mechanical wound debridement as determined by the MolecuLight Procedure (MLiX).'}], 'secondaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'Before, during, and after mechanical debridement within 1 hour', 'description': 'Pain scores (PEG) before, during and after mechanical debridement. Pain intensity of the reference ulcer is assessed before and after any wound cleansing using the PEG score\n\nPEG Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity). The PEG scale is a validated pain scoring system. It consists of three 1-10 rating scales: numerical, enjoyment of life and general activity. The subject indicates a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "Pain as bad as you can imagine" on the right side of the number line. The number 0 represents "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain".'}, {'measure': 'Adverse Events', 'timeFrame': 'During debridement', 'description': 'Adverse events associated with mechanical debridement.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Wounds', 'Chronic Wounds']}, 'descriptionModule': {'briefSummary': 'This prospective clinical trial will compare the bacterial burden in the wound bed and on the periwound skin before and after mechanical debridement with EZ Debride using fluorescence imaging.\n\nAfter consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MLiX). The ulcer is mechanically debridement with the EZ Debride device after which a second MLiX procedure is performed. The investigator will then compare the two images.', 'detailedDescription': 'Acute and chronic wounds burden healthcare systems across the globe. In the United States the cost of nonhealing wounds approximates 100 billion dollars.1-3 The presence of bacteria in and around the wound impedes wound healing. Clinicians treat elevated wound bacterial levels with mechanical and sharp debridement, topical antiseptics and systemic antibiotics. However, evidence on the best methods to reduce bacterial load is lacking. The EZ-1 clinical trial will utilize the latest fluorescence imaging technology to investigate whether mechanical debridement using the EZ Debride® tool reduces bacterial burden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute or chronic wounds', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.\n2. A signed and dated informed consent form.\n3. Subject is willing and able to comply with instructions and scheduled visits.\n\nExclusion Criteria:\n\n1. The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.\n2. The subject's wound has not been present for at least 4 weeks."}, 'identificationModule': {'nctId': 'NCT04342767', 'briefTitle': 'The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds', 'organization': {'class': 'NETWORK', 'fullName': 'SerenaGroup, Inc.'}, 'officialTitle': 'The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds', 'orgStudyIdInfo': {'id': 'EZ-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EZ Debride®', 'type': 'DEVICE', 'description': "EZ Debride ® is intended for the mechanical debridement of topical wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post Mohs' surgery, post-laser surgery, podiatric, wound dehiscence) trauma wounds (abrasions, lacerations, second-degree burns and skin tears), draining wounds and tunnelled /undermined wounds."}]}, 'contactsLocationsModule': {'locations': [{'zip': '15222', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Serena Group Research Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Thomas E Serena, MD,FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SerenaGroup, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SerenaGroup, Inc.', 'class': 'NETWORK'}, 'collaborators': [{'name': 'MDM Wound Ventures, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}