Heal Wound, Ulcer, Leg
Conditions
Brief summary
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.
Interventions
DEVICESensor activation (on DryMax Extra Soft)
Study profile of sensor activation
Sponsors
University Hospital, Linkoeping
S2Clinic
Absorbest AB
Vinnova
Swedish Energy Agency
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Vårdcentralen Åby
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Dressing Changes With Sensor Activation at Correct Timing | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications if the Dressing Was Switched Too Late. | Inclusion visit to study completed after 3 dressing changes, 1-2 weeks | Report of leakage, strike-through and maceration at the time for dressing changes |
| Level of Usability | Inclusion visit to study completed after 3 dressing changes, 1-2 weeks | Study the rate of handling errors |
| Wound Size After Three Dressing Changes | At final dressing change no.3 (after 1-2 weeks) | Wound size after three dressing changes with the study device, measured as cm2. Can be compared with the baseline measurement of wound size. |
Countries
Sweden
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Total | A-B-A | B-A-B |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Sweden | 5 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
| Wound size | 80 cm^2 STANDARD_DEVIATION 47 | 130 cm^2 STANDARD_DEVIATION 32 | 47 cm^2 STANDARD_DEVIATION 17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 3 / 5 | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Population: All patients recieved three dressing changes and were included in the analysis
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Variant A | Number of Dressing Changes With Sensor Activation at Correct Timing | Indication at correct timing | 0 Dressing changes |
| Variant A | Number of Dressing Changes With Sensor Activation at Correct Timing | Indication, but not at correct timing | 4 Dressing changes |
| Variant A | Number of Dressing Changes With Sensor Activation at Correct Timing | No indication | 3 Dressing changes |
| Variant B | Number of Dressing Changes With Sensor Activation at Correct Timing | Indication at correct timing | 0 Dressing changes |
| Variant B | Number of Dressing Changes With Sensor Activation at Correct Timing | Indication, but not at correct timing | 2 Dressing changes |
| Variant B | Number of Dressing Changes With Sensor Activation at Correct Timing | No indication | 6 Dressing changes |
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
Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Population: All patients recieved three dressing changes and were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x10 cm, weight 11 g - 26 g | 0 Dressing changes |
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x20 cm, weight >72 g | 0 Dressing changes |
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x20 cm, weight <17 g | 0 Dressing changes |
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 20x20 cm, weight <26 g | 0 Dressing changes |
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x10 cm, weight >26 g | 0 Dressing changes |
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 20x20 cm, weight 26 g - 109 g | 3 Dressing changes |
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x20 cm, weight 17 g - 62g | 3 Dressing changes |
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 20x20 cm, weight >109 g | 1 Dressing changes |
| Variant A | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x10 cm, weight <11 g | 0 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 20x20 cm, weight >109 g | 2 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x10 cm, weight <11 g | 0 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x10 cm, weight 11 g - 26 g | 0 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x10 cm, weight >26 g | 0 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x20 cm, weight <17 g | 0 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x20 cm, weight 17 g - 62g | 6 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 10x20 cm, weight >72 g | 0 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 20x20 cm, weight <26 g | 0 Dressing changes |
| Variant B | Timing of Dressing Change Related to Dressing Size and Weight After Use | Size 20x20 cm, weight 26 g - 109 g | 0 Dressing changes |
Secondary
Complications if the Dressing Was Switched Too Late.
Report of leakage, strike-through and maceration at the time for dressing changes
Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Population: All patients recieved three dressing changes and were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Variant A | Complications if the Dressing Was Switched Too Late. | Leakage or strike through | 3 Dressing changes |
| Variant A | Complications if the Dressing Was Switched Too Late. | No leakage or strike through | 4 Dressing changes |
| Variant A | Complications if the Dressing Was Switched Too Late. | Maceration due to leakage or strike through | 0 Dressing changes |
| Variant B | Complications if the Dressing Was Switched Too Late. | Leakage or strike through | 2 Dressing changes |
| Variant B | Complications if the Dressing Was Switched Too Late. | No leakage or strike through | 6 Dressing changes |
| Variant B | Complications if the Dressing Was Switched Too Late. | Maceration due to leakage or strike through | 0 Dressing changes |
Secondary
Level of Usability
Study the rate of handling errors
Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Population: All patients recieved three dressing changes and were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Variant A | Level of Usability | Correct application | 7 Dressing changes |
| Variant A | Level of Usability | Use errors | 0 Dressing changes |
| Variant B | Level of Usability | Correct application | 8 Dressing changes |
| Variant B | Level of Usability | Use errors | 0 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.
Time frame: At final dressing change no.3 (after 1-2 weeks)
Population: All patients recieved three dressing changes and were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Variant A | Wound Size After Three Dressing Changes | 127 cm^2 | Standard Deviation 29 |
| Variant B | Wound Size After Three Dressing Changes | 44 cm^2 | Standard Deviation 16 |