Wound Clinical Trial
Official title:
Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor
NCT number | NCT04890769 |
Other study ID # | 0007-P--047 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | May 21, 2021 |
Est. completion date | February 22, 2022 |
Verified date | March 2022 |
Source | Vårdcentralen Åby |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.
Status | Terminated |
Enrollment | 4 |
Est. completion date | February 22, 2022 |
Est. primary completion date | February 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - male or female, =18 years - 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 pregnancy at the inclusion visit - 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Primary Health Care Center in Österlötland | Linköping |
Lead Sponsor | Collaborator |
---|---|
Fredrik Iredahl | Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Questionnaire regarding workflow of the clinical procedure for dressing change | Yes/no questions and questions with multiple choices | Enrollment to study completion (4 weeks) | |
Primary | Questionnaire regarding the satisfaction using the device | Scale 1-5 where 1= low, 5 = good | Through study completion, up to 4 weeks | |
Primary | Registration of device deficiencies | Type of device deficiency | Enrollment to study completion (4 weeks) | |
Primary | Registration of device deficiencies | Severity scale 1-3, 1=low, 3=high | Enrollment to study completion (4 weeks) | |
Secondary | Number of days between visits | Dressing change frequency | Enrollment to study completion (4 weeks) | |
Secondary | Weight of dressing after use using a balance | Utilisation of dressings capacity | Enrollment to study completion (4 weeks) | |
Secondary | Registration of time for display activation | Time for display activation - hours since application [h] | Enrollment to study completion (4 weeks) | |
Secondary | Questionnaire regarding leakage, strike-through, exudate viscosity | Yes/no questions and questions with multiple choices | Enrollment to study completion (4 weeks) | |
Secondary | Questionnaire regarding wound status | Questions with multiple choices | Enrollment to study completion (4 weeks) | |
Secondary | Measurement of wound size with a ruler | Wound size progression | Enrollment to study completion (4 weeks) |
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