Wound Dressing With Moisture Sensor

Clinical Functional Assessment of Moisture Sensor on Wound Dressing

Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.

Study Overview

• Status: Completed
• Conditions: Ulcer, Leg; Heal Wound
• Intervention / Treatment: Device: Sensor activation (on DryMax Extra Soft)

Detailed Description

The function of a novel moisture sensor placed on a superabsorbent wound dressing has been evaluated in a small clinical investigation. Five patients with leg ulcers were included. The investigational device, Absorbest Fuktsensor, was placed on the dressing DryMax Extra Soft. Two variants of the study product were used, Variant A and Variant B. The difference between the variants were that Variant B had an extra layer of a nonwoven between the moisture sensor and the dressing in an attempt to delay the activation of the moisture sensor a little compared to Variant A which was not equipped with this nonwoven layer.

The overall aim was to observe the function of the sensor in clinical use and practical operation. Further the aim was to evaluate the two combinations of Absorbest Fuktsensor and DryMax Extra Soft and decide which combination would activate the sensor display in a satisfactory way related to the utilization of the dressings absorbing capacity while avoiding leakage and maceration.

The study was performed accordingly to ISO 14155 and the declaration of Helsinki.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • S2Clinic
  • Region Östergötland
    • Linköping, Region Östergötland, Sweden
      • Hudkliniken, University hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Presence of moderate to highly exuding leg ulcer by clinician assessment
• Wound deemed suitable for treatment with study product
• Informed consent from the participants.

Exclusion Criteria:

• Pregnancy
• Prisoner
• Bleeding from the wound
• Known allergy to components
• Wound infection
• Mental illness
• 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

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-B-A; Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant A, at next dressing change they received variant B, and on the third dressing change they received variant A again. No washout periods.	Device: Sensor activation (on DryMax Extra Soft); Study profile of sensor activation
Experimental: B-A-B; Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant B, at next dressing change they received variant A, and on the third dressing change they received variant B again. No washout periods.	Device: Sensor activation (on DryMax Extra Soft); Study profile of sensor activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Dressing Changes With Sensor Activation at Correct Timing	Sensor activation - measured as indication on the sensor display; indication at correct time, indication but not att correct time, no indication.	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Timing of Dressing Change Related to Dressing Size and Weight After Use	Dressing weight after use were measured on a scale and recorded. The weight were compared to a predefined table. Dressing size 10x10 cm: Changed too early <11 g Correct change 11-26 g Changed too late >26 g Dressing size 10x20 cm: Changed too early <17 g Correct change 17-62 g Changed too late >62 g Dressing size 20x20 cm: Changed too early <26 g Correct change 26-109 g Changed too late >109 g	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications if the Dressing Was Switched Too Late.	Report of leakage, strike-through and maceration at the time for dressing changes	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Level of Usability	Study the rate of handling errors	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Wound Size After Three Dressing Changes	Wound size after three dressing changes with the study device, measured as cm2. Can be compared with the baseline measurement of wound size.	At final dressing change no.3 (after 1-2 weeks)

Collaborators and Investigators

• Sponsor: Vårdcentralen Åby
• Collaborators: University Hospital, Linkoeping; Vinnova; The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS); S2Clinic, Linköping, Sweden; Absorbest AB; Swedish Energy Agency
• Investigators: Principal Investigator: MD., PhD. Iredahl, Aby vardcentral, Region Ostergotland

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Wounds and Injuries; Leg Ulcer
• Other Study ID Numbers: 2018-01

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