Ulcer, Leg Clinical Trial
Official title:
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.
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.
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