NCT03468816

Wound Dressing With Moisture Sensor

Clinical Functional Assessment of Moisture Sensor on Wound Dressing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Vårdcentralen Åby · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Ulcer, Leg
• Heal Wound

Interventions

Type	Name	Description
DEVICE	Sensor activation (on DryMax Extra Soft)	Study profile of sensor activation

Timeline

• Start date: 2018-05-28
• Primary completion: 2019-11-22
• Completion: 2019-11-22
• First posted: 2018-03-19
• Last updated: 2020-06-02
• Results posted: 2020-06-02

Locations

2 sites across 1 country: Sweden