Wound Dressing With Moisture Sensor

Ulcer, Leg Clinical Trial

Official title:

Clinical Functional Assessment of Moisture Sensor on Wound Dressing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468816
• Other study ID #: 2018-01
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: November 22, 2019

Study information

• Verified date: May 2020
• Source: Vårdcentralen Åby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heal Wound
• Leg Ulcer
• Ulcer, Leg
• Wounds and Injuries

Intervention

Device:
• Sensor activation (on DryMax Extra Soft)
Study profile of sensor activation

Locations

Country	Name	City	State
Sweden	Hudkliniken, University hospital	Linköping	Region Östergötland
Sweden	S2Clinic	Linköping

Sponsors (7)

Lead Sponsor	Collaborator
Vårdcentralen Åby	Absorbest AB, S2Clinic, Linköping, Sweden, Swedish Energy Agency, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), University Hospital, Linkoeping, Vinnova

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Primary	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	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Secondary	Complications if the Dressing Was Switched Too Late.	Report of leakage, strike-through and maceration at the time for dressing changes	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Secondary	Level of Usability	Study the rate of handling errors	Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Secondary	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.	At final dressing change no.3 (after 1-2 weeks)