Trial Outcomes & Findings for A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration (NCT NCT01438541)
NCT ID: NCT01438541
Last Updated: 2016-10-14
Results Overview
Total improvement of erythema
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
14 days
Results posted on
2016-10-14
Participant Flow
The recruitment period was from 03 October 2011-21 February 2012. The study was conducted at three wound care units in United Kingdom.
There was no wash-out or run-in phase included in the study.
Participant milestones
| Measure |
Window
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Window
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
discharge from the hospital
|
5
|
Baseline Characteristics
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
Baseline characteristics by cohort
| Measure |
Window
n=29 Participants
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
|
|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 16.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
29 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Vulnerable subjects with high risk of skin breakdown.
Total improvement of erythema
Outcome measures
| Measure |
Window
n=29 Participants
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
|
|---|---|
|
Erythema ( No/Yes)
Erytema Baseline Yes
|
24 participants
|
|
Erythema ( No/Yes)
Erythema Last visit No
|
16 participants
|
|
Erythema ( No/Yes)
Erytehma Last visit Yes
|
13 participants
|
|
Erythema ( No/Yes)
Erytehma Baseline No
|
5 participants
|
SECONDARY outcome
Timeframe: 14 daysInvestigator and Nurses evaluate the overall Experience of using of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent, Not measured
Outcome measures
| Measure |
Window
n=29 Participants
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
|
|---|---|
|
Overall Experience of Use of the Dressing
Very Poor
|
1 participants
|
|
Overall Experience of Use of the Dressing
Poor
|
10 participants
|
|
Overall Experience of Use of the Dressing
Good
|
15 participants
|
|
Overall Experience of Use of the Dressing
Very Good
|
0 participants
|
|
Overall Experience of Use of the Dressing
Excellent
|
1 participants
|
|
Overall Experience of Use of the Dressing
Not measured
|
2 participants
|
SECONDARY outcome
Timeframe: 14 daysInvestigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent
Outcome measures
| Measure |
Window
n=29 Participants
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
|
|---|---|
|
Evaluate the Dressing Shape
Very Poor
|
0 participants
|
|
Evaluate the Dressing Shape
Poor
|
4 participants
|
|
Evaluate the Dressing Shape
Good
|
22 participants
|
|
Evaluate the Dressing Shape
Very Good
|
1 participants
|
|
Evaluate the Dressing Shape
Excellent
|
2 participants
|
Adverse Events
Window
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 |
Window
n=29 participants at risk
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Ruptured blister - broken skin
|
3.4%
1/29 • Number of events 1 • Adverse Events were collected from baseline to termination (14days)
|
|
Skin and subcutaneous tissue disorders
Recurrence of ruptured blister in different
|
3.4%
1/29 • Number of events 1 • Adverse Events were collected from baseline to termination (14days)
|
|
Skin and subcutaneous tissue disorders
Grade 2 area to L buttock 2mm x 2 mm
|
3.4%
1/29 • Number of events 1 • Adverse Events were collected from baseline to termination (14days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place