Clinical trial NCT03468816: Wound Dressing With Moisture Sensor
Official title: Clinical Functional Assessment of Moisture Sensor on Wound Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcer, Leg
Heal Wound
Lead sponsor: Vårdcentralen Åby
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
name: S2Clinic
name: Absorbest AB
name: Vinnova
name: Swedish Energy Agency
name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
First posted: 2018-03-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Dressing Changes With Sensor Activation at Correct Timing
timeFrame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
measure: Timing of Dressing Change Related to Dressing Size and Weight After Use
timeFrame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Secondary outcomes:
measure: Complications if the Dressing Was Switched Too Late.
timeFrame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
measure: Level of Usability
timeFrame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
measure: Wound Size After Three Dressing Changes
timeFrame: At final dressing change no.3 (after 1-2 weeks)
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Hudkliniken, University hospital
state: Region Östergötland
city: Linköping
country: Sweden
facility: S2Clinic
Study officials:
affiliation: Aby vardcentral, Region Ostergotland
name: MD., PhD. Iredahl
role: PRINCIPAL_INVESTIGATOR
References: