Ulcer, LegNCT03468816
Wound Dressing With Moisture Sensor
A study testing Sensor activation (on DryMax Extra Soft) in people with Ulcer, Leg and Heal Wound, run by Vårdcentralen Åby at 2 sites in Sweden.
Trial summary
Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Leg, Heal Wound
- What is being tested?
- Sensor activation (on DryMax Extra Soft)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesSweden
- Study dates
- 28 May 2018to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of moderate to highly exuding leg ulcer by clinician assessment
- Wound deemed suitable for treatment with study product
- Informed consent from the participants.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Hudkliniken, University hospital
Linköping, Region Östergötland
S2Clinic
Linköping
About this study
Official title: Clinical Functional Assessment of Moisture Sensor on Wound Dressing
Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.
Read the 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.
- Conditions
- Ulcer, Leg, Heal Wound
- Being tested
- Sensor activation (on DryMax Extra Soft)
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor activation (on DryMax Extra Soft)Device
Study profile of sensor activation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sensor activation (on DryMax Extra Soft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Secondary outcomes (3)
Complications if the Dressing Was Switched Too Late.
Report of leakage, strike-through and maceration at the time for dressing changes
Measured: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Level of Usability
Study the rate of handling errors
Measured: 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.
Measured: At final dressing change no.3 (after 1-2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start28 May 2018
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcer, LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vårdcentralen Åby
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, S2Clinic, Absorbest AB, Vinnova, Swedish Energy Agency, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
- Responsible party
- Principal investigator, Fredrik Iredahl, Vårdcentralen Åby
- Investigators
- MD., PhD. Iredahl, Principal investigator, Aby vardcentral, Region Ostergotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468816
- Sponsor's protocol ID
- 2018-01
- Status last verified
- May 2020
- First submitted
- 26 Feb 2018
- Last updated
- 2 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed and published on a group level.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Functional Assessment of Moisture Sensor on Wound Dressing
- ClinicalTrials.gov ID
- NCT03468816
- Acronym / sponsor ID
- 2018-01
- Conditions
- Ulcer, Leg, Heal Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vårdcentralen ÅbyUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, S2Clinic, Absorbest AB, Vinnova, Swedish Energy Agency, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-B-A | Experimental | Device: Sensor activation (on DryMax Extra Soft)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. |
| B-A-B | Experimental | Device: Sensor activation (on DryMax Extra Soft)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of moderate to highly exuding leg ulcer by clinician assessment
- Wound deemed suitable for treatment with study product
- Informed consent from the participants.
Key exclusion criteria (7 listed)
- Pregnancy
- Prisoner
- Bleeding from the wound
- Known allergy to components
- Wound infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor activation (on DryMax Extra Soft)Study profile of sensor activation | Device | A-B-A, B-A-B |
Primary outcome
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.
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
3 secondary outcomes
Complications if the Dressing Was Switched Too Late.
Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Level of Usability
Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Wound Size After Three Dressing Changes
Time frame: At final dressing change no.3 (after 1-2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be analyzed and published on a group level.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD., PhD. Iredahl principal investigator
Aby vardcentral, Region Ostergotland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor activation (on DryMax Extra Soft) in people with Ulcer, Leg and Heal Wound, run by Vårdcentralen Åby at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dressing Changes With Sensor Activation at Correct Timing (time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.