Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04890769
• Other study ID #: 0007-P--047
• Status: Terminated
• Start date: May 21, 2021
• Est. completion date: February 22, 2022

Study information

• Verified date: March 2022
• Source: Vårdcentralen Åby
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer, Leg
• Wound
• Wounds and Injuries

Intervention

Device:
• Moisture sensor wound dressing
Clinical procedure for change of wound dressing

Locations

Country	Name	City	State
Sweden	Primary Health Care Center in Österlötland	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Fredrik Iredahl	Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire regarding workflow of the clinical procedure for dressing change	Yes/no questions and questions with multiple choices	Enrollment to study completion (4 weeks)
Primary	Questionnaire regarding the satisfaction using the device	Scale 1-5 where 1= low, 5 = good	Through study completion, up to 4 weeks
Primary	Registration of device deficiencies	Type of device deficiency	Enrollment to study completion (4 weeks)
Primary	Registration of device deficiencies	Severity scale 1-3, 1=low, 3=high	Enrollment to study completion (4 weeks)
Secondary	Number of days between visits	Dressing change frequency	Enrollment to study completion (4 weeks)
Secondary	Weight of dressing after use using a balance	Utilisation of dressings capacity	Enrollment to study completion (4 weeks)
Secondary	Registration of time for display activation	Time for display activation - hours since application [h]	Enrollment to study completion (4 weeks)
Secondary	Questionnaire regarding leakage, strike-through, exudate viscosity	Yes/no questions and questions with multiple choices	Enrollment to study completion (4 weeks)
Secondary	Questionnaire regarding wound status	Questions with multiple choices	Enrollment to study completion (4 weeks)
Secondary	Measurement of wound size with a ruler	Wound size progression	Enrollment to study completion (4 weeks)