Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04890769
Status:
TERMINATED
Last Update Posted:
2022-03-18
First Post:
2021-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study is terminated by the sponsor due to poor participant recruitment and due to limited opportunity to achieve commercial gain.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire regarding workflow of the clinical procedure for dressing change', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Yes/no questions and questions with multiple choices'}, {'measure': 'Questionnaire regarding the satisfaction using the device', 'timeFrame': 'Through study completion, up to 4 weeks', 'description': 'Scale 1-5 where 1= low, 5 = good'}, {'measure': 'Registration of device deficiencies', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Type of device deficiency'}, {'measure': 'Registration of device deficiencies', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Severity scale 1-3, 1=low, 3=high'}], 'secondaryOutcomes': [{'measure': 'Number of days between visits', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Dressing change frequency'}, {'measure': 'Weight of dressing after use using a balance', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Utilisation of dressings capacity'}, {'measure': 'Registration of time for display activation', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Time for display activation - hours since application \\[h\\]'}, {'measure': 'Questionnaire regarding leakage, strike-through, exudate viscosity', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Yes/no questions and questions with multiple choices'}, {'measure': 'Questionnaire regarding wound status', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Questions with multiple choices'}, {'measure': 'Measurement of wound size with a ruler', 'timeFrame': 'Enrollment to study completion (4 weeks)', 'description': 'Wound size progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exuding Wounds', 'Ulcer, Leg', 'Wound']}, 'descriptionModule': {'briefSummary': 'Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.', 'detailedDescription': "The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds.\n\nUsing DryMax Sensor and the display indication - advisory only - might influence the clinician's workflow and the patient's engagement in their care. The PMCF study aims to study the use of the sensor in the clinical procedure of dressing changes in one or more healthcare settings. To study how the new product is received, and how it is used in the workflow, related to its clinical performance.\n\nFurthermore, the aim is to gather safety-related clinical data for common harms within exudate management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from primary health care', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female, ≥18 years\n* presence of an exuding wound, according to the clinician's assessment\n* the wound is deemed suitable for treatment with DryMax Sensor\n* an appropriate dressing size is available to be used according to the size of the wound\n* the participant has given a written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* known pregnancy at the inclusion visit\n* known or suspected hypersensitivity to the DryMax Sensor or its components\n* mental inability, reluctance or language difficulties that cause difficulties in understanding the meaning of participating in the study\n* ongoing treatment with systemic antibiotics\n* illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study, and/or the dressing."}, 'identificationModule': {'nctId': 'NCT04890769', 'briefTitle': 'Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Vårdcentralen Åby'}, 'officialTitle': 'Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor', 'orgStudyIdInfo': {'id': '0007-P--047'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'Patients with exuding wounds', 'interventionNames': ['Device: Moisture sensor wound dressing']}], 'interventions': [{'name': 'Moisture sensor wound dressing', 'type': 'DEVICE', 'otherNames': ['DryMax Sensor'], 'description': 'Clinical procedure for change of wound dressing', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'country': 'Sweden', 'facility': 'Primary Health Care Center in Österlötland', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Fredrik Iredahl, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be analyzed and published on a group level.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fredrik Iredahl', 'class': 'OTHER'}, 'collaborators': [{'name': 'Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fredrik Iredahl', 'investigatorAffiliation': 'Vårdcentralen Åby'}}}}