Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor

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

Study Overview

• Status: Terminated
• Conditions: Wound; Ulcer, Leg; Exuding Wounds
• Intervention / Treatment: Device: Moisture sensor wound dressing

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 Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Primary Health Care Center in Österlötland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from primary health care

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants; Patients with exuding wounds	Device: Moisture sensor wound dressing; Clinical procedure for change of wound dressing; Other Names: DryMax Sensor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fredrik Iredahl
• Collaborators: Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden
• Investigators: Principal Investigator: Fredrik Iredahl, MD. PhD., Linkoeping University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Wounds and Injuries; Leg Ulcer
• Other Study ID Numbers: 0007-P--047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be analyzed and published on a group level.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No