Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

Study Overview
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Brief Summary
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Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.

Detailed Description
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The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds. 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.

Official Title
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Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor

Conditions
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Exuding Wounds, Ulcer, Leg, Wound

Intervention / Treatment
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* Device: Moisture sensor wound dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Patients with exuding wounds | Device: Moisture sensor wound dressing<br>* Clinical procedure for change of wound dressing<br>* Other names: DryMax Sensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire regarding workflow of the clinical procedure for dressing change | Yes/no questions and questions with multiple choices | Enrollment to study completion (4 weeks) | 
| Questionnaire regarding the satisfaction using the device | Scale 1-5 where 1= low, 5 = good | Through study completion, up to 4 weeks | 
| Registration of device deficiencies | Type of device deficiency | Enrollment to study completion (4 weeks) | 
| Registration of device deficiencies | Severity scale 1-3, 1=low, 3=high | Enrollment to study completion (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days between visits | Dressing change frequency | Enrollment to study completion (4 weeks) | 
| Weight of dressing after use using a balance | Utilisation of dressings capacity | Enrollment to study completion (4 weeks) | 
| Registration of time for display activation | Time for display activation - hours since application [h] | Enrollment to study completion (4 weeks) | 
| Questionnaire regarding leakage, strike-through, exudate viscosity | Yes/no questions and questions with multiple choices | Enrollment to study completion (4 weeks) | 
| Questionnaire regarding wound status | Questions with multiple choices | Enrollment to study completion (4 weeks) | 
| Measurement of wound size with a ruler | Wound size progression | Enrollment to study completion (4 weeks) |