Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds
NCT ID: NCT04890769
Last Updated: 2022-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
4 participants
OBSERVATIONAL
2021-05-21
2022-02-22
Brief Summary
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Detailed Description
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Using 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.
Furthermore, the aim is to gather safety-related clinical data for common harms within exudate management.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants
Patients with exuding wounds
Moisture sensor wound dressing
Clinical procedure for change of wound dressing
Interventions
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Moisture sensor wound dressing
Clinical procedure for change of wound dressing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* presence of an exuding wound, according to the clinician's assessment
* the wound is deemed suitable for treatment with DryMax Sensor
* an appropriate dressing size is available to be used according to the size of the wound
* the participant has given a written informed consent to participate in the study.
Exclusion Criteria
* known or suspected hypersensitivity to the DryMax Sensor or its components
* mental inability, reluctance or language difficulties that cause difficulties in understanding the meaning of participating in the study
* ongoing treatment with systemic antibiotics
* 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.
18 Years
ALL
No
Sponsors
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Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden
UNKNOWN
Fredrik Iredahl
OTHER
Responsible Party
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Fredrik Iredahl
Principal Investigator
Principal Investigators
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Fredrik Iredahl, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Primary Health Care Center in Österlötland
Linköping, , Sweden
Countries
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Other Identifiers
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0007-P--047
Identifier Type: -
Identifier Source: org_study_id
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