Clinical trial NCT04890769: Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds
Official title: Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Exuding Wounds
Ulcer, Leg
Wound
Lead sponsor: Vårdcentralen Åby
Sponsor class: OTHER
Collaborators: name: Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden
First posted: 2021-05-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from primary health care

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Questionnaire regarding workflow of the clinical procedure for dressing change
timeFrame: Enrollment to study completion (4 weeks)
measure: Questionnaire regarding the satisfaction using the device
timeFrame: Through study completion, up to 4 weeks
measure: Registration of device deficiencies
timeFrame: Enrollment to study completion (4 weeks)
measure: Registration of device deficiencies
timeFrame: Enrollment to study completion (4 weeks)
Secondary outcomes:
measure: Number of days between visits
timeFrame: Enrollment to study completion (4 weeks)
measure: Weight of dressing after use using a balance
timeFrame: Enrollment to study completion (4 weeks)
measure: Registration of time for display activation
timeFrame: Enrollment to study completion (4 weeks)
measure: Questionnaire regarding leakage, strike-through, exudate viscosity
timeFrame: Enrollment to study completion (4 weeks)
measure: Questionnaire regarding wound status
timeFrame: Enrollment to study completion (4 weeks)
measure: Measurement of wound size with a ruler
timeFrame: Enrollment to study completion (4 weeks)
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Primary Health Care Center in Österlötland
Study officials:
affiliation: Linkoeping University
name: Fredrik Iredahl, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: