Wound Dressing With Moisture Sensor

Vårdcentralen Åby5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcer, Leg Heal Wound

Interventions

Sensor activation (on DryMax Extra Soft)DEVICE

Study profile of sensor activation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hudkliniken, University hospital

Linköping, Region Östergötland, Sweden

S2Clinic

Linköping, Sweden

Outcomes

Primary Outcomes

Number of Dressing Changes With Sensor Activation at Correct Timing

Sensor activation - measured as indication on the sensor display; indication at correct time, indication but not att correct time, no indication.

Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Timing of Dressing Change Related to Dressing Size and Weight After Use

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

Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Secondary Outcomes

Complications if the Dressing Was Switched Too Late.

Report of leakage, strike-through and maceration at the time for dressing changes

Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Level of Usability

Study the rate of handling errors

Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Wound Size After Three Dressing Changes

Wound size after three dressing changes with the study device, measured as cm2. Can be compared with the baseline measurement of wound size.

Time frame: At final dressing change no.3 (after 1-2 weeks)

Data from ClinicalTrials.gov

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