Wound Dressing With Moisture Sensor

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2019-11-22

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.

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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.

Conditions

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Ulcer, Leg Heal Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sensor activation (on DryMax Extra Soft)

Intervention Type DEVICE

Study profile of sensor activation

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.

Group Type EXPERIMENTAL

Sensor activation (on DryMax Extra Soft)

Intervention Type DEVICE

Study profile of sensor activation

Interventions

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Sensor activation (on DryMax Extra Soft)

Study profile of sensor activation

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No