Wound Dressing With Moisture Sensor

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

Detailed Description
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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.

Official Title
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Clinical Functional Assessment of Moisture Sensor on Wound Dressing

Conditions
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Ulcer, Leg, Heal Wound

Intervention / Treatment
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* Device: Sensor activation (on DryMax Extra Soft)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-B-A<br>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)<br>* Study profile of sensor activation<br>|
| Experimental: B-A-B<br>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)<br>* Study profile of sensor activation<br>|

What is the study measuring?
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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) |