Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

Terminated

• Conditions: Exuding Wounds; Ulcer, Leg; Wound
• Interventions: Device: Moisture sensor wound dressing

• Registration Number: NCT04890769
• Lead Sponsor: Fredrik Iredahl

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.

Study Timeline

• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Study Start: 2021-05-21
• Primary Completion: 2022-02-22
• Study Completion: 2022-02-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Moisture sensor wound dressing	Patients with exuding wounds

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Primary Health Care Center in Österlötland; 🇸🇪 Linköping, Sweden