Wound Dressing With Moisture Sensor

Vårdcentralen Åby

Status: Completed

Conditions: Ulcer, Leg; Heal Wound

Treatments: Device: Sensor activation (on DryMax Extra Soft)

Study type: Interventional

Funder types: Other

Identifiers

NCT03468816

2018-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

A-B-A

Experimental group

Description:

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.

Treatment:

Device: Sensor activation (on DryMax Extra Soft)

B-A-B

Experimental group

Description:

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.

Treatment:

Device: Sensor activation (on DryMax Extra Soft)