Exuding WoundsNCT04890769
Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds
An observational study of Exuding Wounds and Ulcer, Leg, run by Fredrik Iredahl at 1 site in Sweden.
Trial summary
Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exuding Wounds, Ulcer, Leg, Wound
- What is being tested?
- Moisture sensor wound dressing
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteSweden
- Study dates
- 21 May 2021to 22 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients from primary health care
Who may be able to join
- male or female, ≥18 years
- presence of an exuding wound, according to the clinician's assessment
- the wound is deemed suitable for treatment with DryMax Sensor
- an appropriate dressing size is available to be used according to the size of the wound
- the participant has given a written informed consent to participate in the study.
Who cannot join
- known pregnancy at the inclusion visit
- known or suspected hypersensitivity to the DryMax Sensor or its components
- mental inability, reluctance or language difficulties that cause difficulties in understanding the meaning of participating in the study
- ongoing treatment with systemic antibiotics
- 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
1 site in 1 country.
About this study
Official title: Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor
Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.
Read the detailed description
The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds.
Using DryMax Sensor and the display indication - advisory only - might influence the clinician's workflow and the patient's engagement in their care. The PMCF study aims to study the use of the sensor in the clinical procedure of dressing changes in one or more healthcare settings. To study how the new product is received, and how it is used in the workflow, related to its clinical performance.
Furthermore, the aim is to gather safety-related clinical data for common harms within exudate management.
- Conditions
- Exuding Wounds, Ulcer, Leg, Wound
- Being tested
- Moisture sensor wound dressing
- Medical subject headings
- Leg Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisture sensor wound dressingDevice
Also called DryMax Sensor
Clinical procedure for change of wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Participants | Patients with exuding wounds Receives: Device: Moisture sensor wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire regarding workflow of the clinical procedure for dressing change
Yes/no questions and questions with multiple choices
Measured: Enrollment to study completion (4 weeks)
Questionnaire regarding the satisfaction using the device
Scale 1-5 where 1= low, 5 = good
Measured: Through study completion, up to 4 weeks
Registration of device deficiencies
Type of device deficiency
Measured: Enrollment to study completion (4 weeks)
Registration of device deficiencies
Severity scale 1-3, 1=low, 3=high
Measured: Enrollment to study completion (4 weeks)
Secondary outcomes (6)
Number of days between visits
Dressing change frequency
Measured: Enrollment to study completion (4 weeks)
Weight of dressing after use using a balance
Utilisation of dressings capacity
Measured: Enrollment to study completion (4 weeks)
Registration of time for display activation
Time for display activation - hours since application [h]
Measured: Enrollment to study completion (4 weeks)
Questionnaire regarding leakage, strike-through, exudate viscosity
Yes/no questions and questions with multiple choices
Measured: Enrollment to study completion (4 weeks)
Questionnaire regarding wound status
Questions with multiple choices
Measured: Enrollment to study completion (4 weeks)
Measurement of wound size with a ruler
Wound size progression
Measured: Enrollment to study completion (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start21 May 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Why it stopped: The study is terminated by the sponsor due to poor participant recruitment and due to limited opportunity to achieve commercial gain.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exuding WoundsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fredrik Iredahl
- Sponsor type
- University, hospital or other
- Collaborators
- Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden
- Responsible party
- Sponsor-investigator, Fredrik Iredahl, Vårdcentralen Åby
- Investigators
- Fredrik Iredahl, MD. PhD., Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890769
- Sponsor's protocol ID
- 0007-P--047
- Status last verified
- Mar 2022
- First submitted
- 26 Apr 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor
- ClinicalTrials.gov ID
- NCT04890769
- Acronym / sponsor ID
- 0007-P--047
- Conditions
- Exuding Wounds, Ulcer, Leg, Wound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study is terminated by the sponsor due to poor participant recruitment and due to limited opportunity to achieve commercial gain.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fredrik IredahlUniversity, hospital or other
- Collaborators
- Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden
- Study start
- 21 May 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.
Detailed description
The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds.
Using DryMax Sensor and the display indication - advisory only - might influence the clinician's workflow and the patient's engagement in their care. The PMCF study aims to study the use of the sensor in the clinical procedure of dressing changes in one or more healthcare settings. To study how the new product is received, and how it is used in the workflow, related to its clinical performance.
Furthermore, the aim is to gather safety-related clinical data for common harms within exudate management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: Moisture sensor wound dressingPatients with exuding wounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from primary health care
Key inclusion criteria (5 listed)
- male or female, ≥18 years
- presence of an exuding wound, according to the clinician's assessment
- the wound is deemed suitable for treatment with DryMax Sensor
- an appropriate dressing size is available to be used according to the size of the wound
- the participant has given a written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- known pregnancy at the inclusion visit
- known or suspected hypersensitivity to the DryMax Sensor or its components
- mental inability, reluctance or language difficulties that cause difficulties in understanding the meaning of participating in the study
- ongoing treatment with systemic antibiotics
- 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.
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 |
|---|---|---|
| Moisture sensor wound dressingAlso: DryMax SensorClinical procedure for change of wound dressing | Device | Participants |
Primary outcome
Questionnaire regarding workflow of the clinical procedure for dressing change
Time frame: Enrollment to study completion (4 weeks)
Yes/no questions and questions with multiple choices
Questionnaire regarding the satisfaction using the device
Time frame: Through study completion, up to 4 weeks
Scale 1-5 where 1= low, 5 = good
Registration of device deficiencies
Time frame: Enrollment to study completion (4 weeks)
Type of device deficiency
Registration of device deficiencies
Time frame: Enrollment to study completion (4 weeks)
Severity scale 1-3, 1=low, 3=high
6 secondary outcomes
Number of days between visits
Time frame: Enrollment to study completion (4 weeks)
Weight of dressing after use using a balance
Time frame: Enrollment to study completion (4 weeks)
Registration of time for display activation
Time frame: Enrollment to study completion (4 weeks)
Questionnaire regarding leakage, strike-through, exudate viscosity
Time frame: Enrollment to study completion (4 weeks)
Questionnaire regarding wound status
Time frame: Enrollment to study completion (4 weeks)
Measurement of wound size with a ruler
Time frame: Enrollment to study completion (4 weeks)
Results and safety
The study was stopped early (reason given: The study is terminated by the sponsor due to poor participant recruitment and due to limited opportunity to achieve commercial gain.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No. Data will be analyzed and published on a group level.
Related trials for Exuding Wounds
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A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
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A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
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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.
Fredrik Iredahl, MD. PhD. principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exuding Wounds and Ulcer, Leg, run by Fredrik Iredahl at 1 site 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: The study is terminated by the sponsor due to poor participant recruitment and due to limited opportunity to achieve commercial gain.). Results are not available in the source record.
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?
Questionnaire regarding workflow of the clinical procedure for dressing change (time frame: Enrollment to study completion (4 weeks)). The study lists 4 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 18 Mar 2022.