Trial Outcomes & Findings for Wound Dressing With Moisture Sensor (NCT NCT03468816)
NCT ID: NCT03468816
Last Updated: 2020-06-02
Results Overview
Sensor activation - measured as indication on the sensor display; indication at correct time, indication but not att correct time, no indication.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Results posted on
2020-06-02
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
A-B-A
n=2 Participants
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
n=3 Participants
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.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
|
Wound size
|
130 cm^2
STANDARD_DEVIATION 32 • n=2 Participants
|
47 cm^2
STANDARD_DEVIATION 17 • n=3 Participants
|
80 cm^2
STANDARD_DEVIATION 47 • n=5 Participants
|
PRIMARY outcome
Timeframe: Inclusion visit to study completed after 3 dressing changes, 1-2 weeksPopulation: All patients recieved three dressing changes and were included in the analysis
Sensor activation - measured as indication on the sensor display; indication at correct time, indication but not att correct time, no indication.
Outcome measures
| Measure |
Variant A
n=7 Dressing changes
Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used.
|
Variant B
n=8 Dressing changes
Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used.
|
|---|---|---|
|
Number of Dressing Changes With Sensor Activation at Correct Timing
Indication at correct timing
|
0 Dressing changes
|
0 Dressing changes
|
|
Number of Dressing Changes With Sensor Activation at Correct Timing
Indication, but not at correct timing
|
4 Dressing changes
|
2 Dressing changes
|
|
Number of Dressing Changes With Sensor Activation at Correct Timing
No indication
|
3 Dressing changes
|
6 Dressing changes
|
PRIMARY outcome
Timeframe: Inclusion visit to study completed after 3 dressing changes, 1-2 weeksPopulation: All patients recieved three dressing changes and were included in the analysis.
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
Outcome measures
| Measure |
Variant A
n=7 Dressing changes
Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used.
|
Variant B
n=8 Dressing changes
Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used.
|
|---|---|---|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 10x10 cm, weight <11 g
|
0 Dressing changes
|
0 Dressing changes
|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 10x10 cm, weight 11 g - 26 g
|
0 Dressing changes
|
0 Dressing changes
|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 10x10 cm, weight >26 g
|
0 Dressing changes
|
0 Dressing changes
|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 10x20 cm, weight <17 g
|
0 Dressing changes
|
0 Dressing changes
|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 10x20 cm, weight 17 g - 62g
|
3 Dressing changes
|
6 Dressing changes
|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 10x20 cm, weight >72 g
|
0 Dressing changes
|
0 Dressing changes
|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 20x20 cm, weight >109 g
|
1 Dressing changes
|
2 Dressing changes
|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 20x20 cm, weight <26 g
|
0 Dressing changes
|
0 Dressing changes
|
|
Timing of Dressing Change Related to Dressing Size and Weight After Use
Size 20x20 cm, weight 26 g - 109 g
|
3 Dressing changes
|
0 Dressing changes
|
SECONDARY outcome
Timeframe: Inclusion visit to study completed after 3 dressing changes, 1-2 weeksPopulation: All patients recieved three dressing changes and were included in the analysis.
Report of leakage, strike-through and maceration at the time for dressing changes
Outcome measures
| Measure |
Variant A
n=7 Dressing changes
Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used.
|
Variant B
n=8 Dressing changes
Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used.
|
|---|---|---|
|
Complications if the Dressing Was Switched Too Late.
Leakage or strike through
|
3 Dressing changes
|
2 Dressing changes
|
|
Complications if the Dressing Was Switched Too Late.
No leakage or strike through
|
4 Dressing changes
|
6 Dressing changes
|
|
Complications if the Dressing Was Switched Too Late.
Maceration due to leakage or strike through
|
0 Dressing changes
|
0 Dressing changes
|
SECONDARY outcome
Timeframe: Inclusion visit to study completed after 3 dressing changes, 1-2 weeksPopulation: All patients recieved three dressing changes and were included in the analysis.
Study the rate of handling errors
Outcome measures
| Measure |
Variant A
n=7 Dressing changes
Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used.
|
Variant B
n=8 Dressing changes
Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used.
|
|---|---|---|
|
Level of Usability
Correct application
|
7 Dressing changes
|
8 Dressing changes
|
|
Level of Usability
Use errors
|
0 Dressing changes
|
0 Dressing changes
|
SECONDARY outcome
Timeframe: At final dressing change no.3 (after 1-2 weeks)Population: All patients recieved three dressing changes and were included in the analysis.
Wound size after three dressing changes with the study device, measured as cm2. Can be compared with the baseline measurement of wound size.
Outcome measures
| Measure |
Variant A
n=2 Participants
Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used.
|
Variant B
n=3 Participants
Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used.
|
|---|---|---|
|
Wound Size After Three Dressing Changes
|
127 cm^2
Standard Deviation 29
|
44 cm^2
Standard Deviation 16
|
Adverse Events
Variant A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Variant B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Variant A
n=5 participants at risk
Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used.
|
Variant B
n=5 participants at risk
Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Mechanical imprint
|
20.0%
1/5 • Number of events 1 • 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.
|
40.0%
2/5 • Number of events 2 • 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.
|
|
Skin and subcutaneous tissue disorders
Adherence
|
20.0%
1/5 • Number of events 1 • 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.
|
0.00%
0/5 • 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.
|
|
Skin and subcutaneous tissue disorders
Pain
|
20.0%
1/5 • Number of events 1 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
High INR value
|
0.00%
0/5 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Infections and infestations
Infection
|
0.00%
0/5 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Inflamed surrounding skin
|
20.0%
1/5 • Number of events 1 • 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.
|
0.00%
0/5 • 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.
|
Additional Information
Dr. Fredrik Iredahl
Åby vårdcentral, County council of Östergötland
Phone: 010-103 00 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place