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Completed

NCT Number: NCT03468816

Wound Dressing With Moisture Sensor

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

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Key information

Conditions

Ulcer, Leg Heal Wound Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hudkliniken, University hospital, Linköping, Region Östergötland, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensor activation (on DryMax Extra Soft)

Device

Study profile of sensor activation

Primary outcomes

  1. Number of Dressing Changes With Sensor Activation at Correct Timing

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Complications if the Dressing Was Switched Too Late.

    Time frame: 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

  2. Level of Usability

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

    Study the rate of handling errors

  3. Wound Size After Three Dressing Changes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vårdcentralen Åby

Other

Collaborators

  • Absorbest AB
  • S2Clinic
  • Swedish Energy Agency
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
  • University Hospital, Linkoeping
  • Vinnova

Registry information

Official study title

Clinical Functional Assessment of Moisture Sensor on Wound Dressing

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2018
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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