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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01354899
First received: May 16, 2011
Last updated: April 5, 2016
Last verified: April 2016
Results First Received: February 25, 2016  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Critical Illness

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from 17 May 2011 - 29 June 2011. The study was conducted at four intensive care units in Sweden.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no wash-out or run-in phase included in the study.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Window  
STARTED     24  
COMPLETED     21  
NOT COMPLETED     3  
discharge from the hospital                 2  
Protocol Violation                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
    Window  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean (Standard Deviation)
  62.1  (17.1)  
Gender  
[units: participants]
 
Female     9  
Male     15  
Region of Enrollment  
[units: participants]
 
Sweden     24  



  Outcome Measures
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1.  Primary:   Erythema (No/Yes)   [ Time Frame: During 5 days ]

2.  Secondary:   Overall Experience of Use of the Dressing   [ Time Frame: During 5 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tina Kjellen
Organization: Molnlycke Health Care AB
phone: +46317223098
e-mail: tina.kjellen@molnlycke.com



Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01354899     History of Changes
Other Study ID Numbers: WINDOW 01
Window 02
Study First Received: May 16, 2011
Results First Received: February 25, 2016
Last Updated: April 5, 2016
Health Authority: Sweden: Regional Ethical Review Board