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An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178126
First Posted: September 15, 2005
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
David Brienza, University of Pittsburgh
Results First Submitted: October 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Pressure Ulcer
Interventions: Device: Skin Protection Wheelchair Seat Cushion
Device: Segmented Foam Wheelchair Seat Cushion

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Segmented Foam Cushion

Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes

Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion

Skin Protection Cushion

Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion

Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion


Participant Flow:   Overall Study
    Segmented Foam Cushion   Skin Protection Cushion
STARTED   119   113 
COMPLETED   94   86 
NOT COMPLETED   25   27 
Lost to Follow-up                21                21 
did not receive intervention                4                6 



  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.
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Reporting Groups
  Description
Segmented Foam Cushion

Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes

Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion

Skin Protection Cushion

Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion

Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion

Total Total of all reporting groups

Baseline Measures
   Segmented Foam Cushion   Skin Protection Cushion   Total 
Overall Participants Analyzed 
[Units: Participants]
 119   113   232 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      119 100.0%      113 100.0%      232 100.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 86.5  (7.7)   86.7  (7.4)   86.6  (7.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      106  89.1%      91  80.5%      197  84.9% 
Male      13  10.9%      22  19.5%      35  15.1% 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.0  (5.2)   24.6  (4.4)   24.8  (4.8) 
Incontinence 
[Units: Participants]
 97   97   194 


  Outcome Measures

1.  Primary:   Sitting-induced Pressure Ulcers   [ Time Frame: 6 months ]


  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: David Brienza
Organization: University of PIttsburgh
phone: (412) 624-6383
e-mail: DBrienza@pitt.edu


Publications of Results:

Responsible Party: David Brienza, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00178126     History of Changes
Other Study ID Numbers: 0403061
R01HD041490 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: October 11, 2016
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017