Wound Dressing With Moisture Sensor

NCT03468816 | Completed Results DMC

• 1 other identifier: 2018-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Ulcer, Leg; Heal Wound

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Complications if the Dressing Was Switched Too Late.

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

• Level of Usability

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

• Wound Size After Three Dressing Changes

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

Study Arms (2)

A-B-A

EXPERIMENTAL

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.

Device: Sensor activation (on DryMax Extra Soft)

B-A-B

EXPERIMENTAL

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.

Device: Sensor activation (on DryMax Extra Soft)

Interventions

Sensor activation (on DryMax Extra Soft) DEVICE

Study profile of sensor activation

A-B-A; B-A-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of moderate to highly exuding leg ulcer by clinician assessment
• Wound deemed suitable for treatment with study product
• Informed consent from the participants.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Hudkliniken, University hospital

Linköping, Region Östergötland, Sweden

Location

S2Clinic

Linköping, Sweden

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Small trial, a first test of concept using a moisture sensor on top of a wound dressing.

Results Point of Contact

• Title: Dr. Fredrik Iredahl
• Organization: Åby vårdcentral, County council of Östergötland

fredrik.iredahl@liu.se

010-103 00 00

Study Officials

• MD., PhD. Iredahl

  Aby vardcentral, Region Ostergotland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 19, 2018
• Study Start: May 28, 2018
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: June 2, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)