Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.
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.
Study Type
OBSERVATIONAL
Enrollment
4
Clinical procedure for change of wound dressing
Primary Health Care Center in Österlötland
Linköping, Sweden
Questionnaire regarding workflow of the clinical procedure for dressing change
Yes/no questions and questions with multiple choices
Time frame: Enrollment to study completion (4 weeks)
Questionnaire regarding the satisfaction using the device
Scale 1-5 where 1= low, 5 = good
Time frame: Through study completion, up to 4 weeks
Registration of device deficiencies
Type of device deficiency
Time frame: Enrollment to study completion (4 weeks)
Registration of device deficiencies
Severity scale 1-3, 1=low, 3=high
Time frame: Enrollment to study completion (4 weeks)
Number of days between visits
Dressing change frequency
Time frame: Enrollment to study completion (4 weeks)
Weight of dressing after use using a balance
Utilisation of dressings capacity
Time frame: Enrollment to study completion (4 weeks)
Registration of time for display activation
Time for display activation - hours since application \[h\]
Time frame: Enrollment to study completion (4 weeks)
Questionnaire regarding leakage, strike-through, exudate viscosity
Yes/no questions and questions with multiple choices
Time frame: Enrollment to study completion (4 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Questionnaire regarding wound status
Questions with multiple choices
Time frame: Enrollment to study completion (4 weeks)
Measurement of wound size with a ruler
Wound size progression
Time frame: Enrollment to study completion (4 weeks)