Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

Fredrik Iredahl

Status: Terminated

Conditions: Ulcer, Leg; Wound; Exuding Wounds

Treatments: Device: Moisture sensor wound dressing

Study type: Observational

Funder types: Other

Identifiers

NCT04890769

0007-P--047

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

4 participants in 1 patient group

Participants

Description:

Patients with exuding wounds

Treatment:

Device: Moisture sensor wound dressing