Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Linkoeping | OTHER |
| S2Clinic | OTHER |
| Absorbest AB | OTHER |
| Vinnova |
Not provided
Not provided
Not provided
Not provided
Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor activation (on DryMax Extra Soft) | Device | Study profile of sensor activation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Level of Usability |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD., PhD. Iredahl | Aby vardcentral, Region Ostergotland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hudkliniken, University hospital | Linköping | Region Östergötland | Sweden | |||
| S2Clinic |
Data will be analyzed and published on a group level.
Not provided
Not provided
Not provided
Not provided
Each enrolled participant used both investigational device Variant A and Variant B in either the order A-B-A or B-A-B according to a pre-designed schedule to ensure equal numbers in the two study arms. All 5 enrolled participants completed the study.
61 patients were screened for eligibility between May 2018 and December 2019 at the Dermatology department at University Hospital in Linköping, Sweden and 2 of these patients were enrolled.
3 patients were screented for eligibiity and enrolled between July 2019 and December 2019 at S2Clinic in Linköping, Sweden.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A-B-A | 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 |
| FG001 | B-A-B | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A-B-A | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All patients recieved three dressing changes and were included in the analysis | Posted | Count of Units | Dressing changes | Inclusion visit to study completed after 3 dressing changes, 1-2 weeks | Dressing changes | Dressing changes |
|
Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Adverse Event Reporting described in CIP and reported in the CRFs. All participants in the study used Variant A and Variant B at least one time.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Variant A | Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mechanical imprint | Skin and subcutaneous tissue disorders | Systematic Assessment | Mechanical imprint from study product. Reported as mild intensity. |
Small trial, a first test of concept using a moisture sensor on top of a wound dressing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fredrik Iredahl | Åby vårdcentral, County council of Östergötland | 010-103 00 00 | fredrik.iredahl@liu.se |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2020 | Apr 16, 2020 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Swedish Energy Agency | OTHER |
| The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS) | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Study the rate of handling errors
| 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. | At final dressing change no.3 (after 1-2 weeks) |
| Linköping |
| Sweden |
| BG001 |
| B-A-B |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Wound size | Size of wound at inclusion of study, measured as cm2 | Mean | Standard Deviation | cm^2 |
|
|
|
| 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 | All patients recieved three dressing changes and were included in the analysis. | Posted | Count of Units | Dressing changes | Inclusion visit to study completed after 3 dressing changes, 1-2 weeks | Dressing changes | Dressing changes |
|
|
|
| Secondary | Complications if the Dressing Was Switched Too Late. | Report of leakage, strike-through and maceration at the time for dressing changes | All patients recieved three dressing changes and were included in the analysis. | Posted | Count of Units | Dressing changes | Inclusion visit to study completed after 3 dressing changes, 1-2 weeks | Dressing changes | Dressing changes |
|
|
|
| Secondary | Level of Usability | Study the rate of handling errors | All patients recieved three dressing changes and were included in the analysis. | Posted | Count of Units | Dressing changes | Inclusion visit to study completed after 3 dressing changes, 1-2 weeks | Dressing changes | Dressing changes |
|
|
|
| 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. | All patients recieved three dressing changes and were included in the analysis. | Posted | Mean | Standard Deviation | cm^2 | At final dressing change no.3 (after 1-2 weeks) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | Variant B | Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used. | 0 | 5 | 0 | 5 | 2 | 5 |
|
| Adherence | Skin and subcutaneous tissue disorders | Systematic Assessment | Dressing adhered to the wound. Reported as mild intensity. |
|
| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Pain in the wound area. One report of mild pain unlikley related to the study device. One report of more pain with moderate intensity and only possibly related to the study device. |
|
| High INR value | Blood and lymphatic system disorders | Systematic Assessment | High INR value in a blood sample taken between two visits. Unlikley related to the study product. |
|
| Infection | Infections and infestations | Systematic Assessment | Growth of Pseudomonas in wound. Graded as mild intensity and only possibly related to the study device. |
|
| Inflamed surrounding skin | Skin and subcutaneous tissue disorders | Systematic Assessment | Inflamed surrounding skin. Graded as mild intensity and only possibly related to the study device. |
|
Not provided
Not provided
| Size 10x10 cm, weight >26 g |
|
| Size 10x20 cm, weight <17 g |
|
| Size 10x20 cm, weight 17 g - 62g |
|
| Size 10x20 cm, weight >72 g |
|
| Size 20x20 cm, weight <26 g |
|
| Size 20x20 cm, weight 26 g - 109 g |
|
| Size 20x20 cm, weight >109 g |
|
| Maceration due to leakage or strike through |
|