Trial Outcomes & Findings for A Open Study to Evaluate the Performance of Dressing on Subject With High Risk of Skin Breakdown (NCT NCT01354899)

NCT ID: NCT01354899

Last Updated: 2016-05-09

Results Overview

Measure number of skin breakdown during from enrolment to termination.

• Recruitment status: COMPLETED
• Target enrollment: 24 participants
• Primary outcome timeframe: During 5 days
• Results posted on: 2016-05-09

Participant Flow

The recruitment period was from 17 May 2011 - 29 June 2011. The study was conducted at four intensive care units in Sweden.

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. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer.
Overall Study STARTED	24
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	3

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. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer.
Overall Study discharge from the hospital	2
Overall Study Protocol Violation	1

Baseline Characteristics

A Open Study to Evaluate the Performance of Dressing on Subject With High Risk of Skin Breakdown

Baseline characteristics by cohort

Measure	Window n=24 Participants WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer.
Age, Continuous	62.1 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment Sweden	24 participants n=5 Participants

PRIMARY outcome

Timeframe: During 5 days

Measure number of skin breakdown during from enrolment to termination.

Outcome measures

Measure	Window n=24 Participants WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer.
Erythema (No/Yes) No	21 participants
Erythema (No/Yes) Yes	3 participants

SECONDARY outcome

Timeframe: During 5 days

Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent

Outcome measures

Measure	Window n=24 Participants WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer.
Overall Experience of Use of the Dressing Very poor	1 participants
Overall Experience of Use of the Dressing Poor	3 participants
Overall Experience of Use of the Dressing Good	10 participants
Overall Experience of Use of the Dressing Very good	9 participants
Overall Experience of Use of the Dressing Excellent	1 participants

Adverse Events

Window

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure

Window n=24 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. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer.

Vascular disorders Death

4.2% 1/24 • Number of events 1 • Adverse Event were collected from enrollment to termination ( 5 days)

Other adverse events

Measure	Window n=24 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. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer.
Cardiac disorders Brady cardia	4.2% 1/24 • Number of events 1 • Adverse Event were collected from enrollment to termination ( 5 days)
Skin and subcutaneous tissue disorders Pressure Ulcer	16.7% 4/24 • Number of events 5 • Adverse Event were collected from enrollment to termination ( 5 days)
Respiratory, thoracic and mediastinal disorders Pneumoni	4.2% 1/24 • Number of events 1 • Adverse Event were collected from enrollment to termination ( 5 days)
Cardiac disorders Tachy Cardia	4.2% 1/24 • Number of events 1 • Adverse Event were collected from enrollment to termination ( 5 days)
Cardiac disorders Arterial Flutter	4.2% 1/24 • Number of events 1 • Adverse Event were collected from enrollment to termination ( 5 days)
Infections and infestations Thromboflebitis in right arm	4.2% 1/24 • Number of events 1 • Adverse Event were collected from enrollment to termination ( 5 days)
Respiratory, thoracic and mediastinal disorders Bronchospasm	4.2% 1/24 • Number of events 1 • Adverse Event were collected from enrollment to termination ( 5 days)
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.2% 1/24 • Number of events 1 • Adverse Event were collected from enrollment to termination ( 5 days)

Additional Information

Tina Kjellen

Molnlycke Health Care AB

Phone: +46317223098

Email: tina.kjellen@molnlycke.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place