Wound Dressing With Moisture Sensor

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
A-B-A	Sensor activation (on DryMax Extra Soft)	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.
B-A-B	Sensor activation (on DryMax Extra Soft)	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.

Primary Outcome Measures

Name	Time	Method
Number of Dressing Changes With Sensor Activation at Correct Timing	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks	Sensor activation - measured as indication on the sensor display; indication at correct time, indication but not att correct time, no indication.
Timing of Dressing Change Related to Dressing Size and Weight After Use	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks	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

Secondary Outcome Measures

Name	Time	Method
Level of Usability	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks	Study the rate of handling errors
Wound Size After Three Dressing Changes	At final dressing change no.3 (after 1-2 weeks)	Wound size after three dressing changes with the study device, measured as cm2. Can be compared with the baseline measurement of wound size.
Complications if the Dressing Was Switched Too Late.	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks	Report of leakage, strike-through and maceration at the time for dressing changes

Locations (2): Hudkliniken, University hospital
🇸🇪
Linköping, Region Östergötland, Sweden
S2Clinic
🇸🇪
Linköping, Sweden
Hudkliniken, University hospital
🇸🇪Linköping, Region Östergötland, Sweden