Exuding Wounds, Ulcer, Leg, Wound
Conditions
Brief summary
Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.
Detailed description
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.
Interventions
DEVICEMoisture sensor wound dressing
Clinical procedure for change of wound dressing
Sponsors
Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden
Fredrik Iredahl
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire regarding workflow of the clinical procedure for dressing change | Enrollment to study completion (4 weeks) | Yes/no questions and questions with multiple choices |
| Questionnaire regarding the satisfaction using the device | Through study completion, up to 4 weeks | Scale 1-5 where 1= low, 5 = good |
| Registration of device deficiencies | Enrollment to study completion (4 weeks) | Type of device deficiency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire regarding leakage, strike-through, exudate viscosity | Enrollment to study completion (4 weeks) | Yes/no questions and questions with multiple choices |
| Number of days between visits | Enrollment to study completion (4 weeks) | Dressing change frequency |
| Measurement of wound size with a ruler | Enrollment to study completion (4 weeks) | Wound size progression |
| Questionnaire regarding wound status | Enrollment to study completion (4 weeks) | Questions with multiple choices |
| Weight of dressing after use using a balance | Enrollment to study completion (4 weeks) | Utilisation of dressings capacity |
| Registration of time for display activation | Enrollment to study completion (4 weeks) | Time for display activation - hours since application \[h\] |
Countries
Sweden
Outcome results
None listed