Pressure UlcerNCT00178126
An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions
A study testing Skin Protection Wheelchair Seat Cushion and Segmented Foam Wheelchair Seat Cushion in people with Pressure Ulcer, run by University of Pittsburgh at 1 site in United States.
Trial summary
The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Skin Protection Wheelchair Seat Cushion and Segmented Foam Wheelchair Seat Cushion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 and older
- use wheelchair > 6 hours per day
- no pressure ulcer on sitting surface
- Braden score of 18 or less
- combined activity and mobility Braden sub-score of 5 or less
Who cannot join
- Body Weight exceeds 250 lbs.
- Hip Width exceeds 20 inches
- does not meet all criteria of seating needs assessment
- current use of cushioning material or wheelchair better than study devices
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: An RCT on Preventing Pressure Ulcers With Seat Cushions
The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of pressure-reducing cushions as a preventive measure against sitting-acquired pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.
Read the detailed description
Pressure ulcers (aka pressure sores, bed sores and decubitus ulcers) are a significant healthcare problem for the growing number of United States elderly long-term care (LTC) residents. Pressure ulcers (PU) diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs.
Despite Federal preventive mandates for the long-term care (LTC) setting, widespread non-compliance occurs. The last three Centers for Medicare and Medicaid Services (CMS) LTC surveys showed a cumulative increase of 21% in the number of citations issued for failure to provide proper intervention to prevent or treat pressure ulcers. Costs for the management of PU in the US likely exceed $6.4 billion annually with a prevalence of approximately 28% in the LTC population.
Estimates of the number of sitting-acquired PU in the elderly, at-risk population range from 36-50%. Several studies, including our own pilot investigation, support these estimates and have suggested that the use of wheelchair cushions designed to reduce interface pressure will reduce the incidence of sitting-acquired PU. Despite this evidence, elderly wheelchair users are not routinely evaluated for seating and positioning needs as definitive studies have not been completed to justify funding for such seating interventions. Consequently, elderly Medicare beneficiaries are being denied access to medically necessary and clinically appropriate interventions and instead are most frequently provided with convoluted or segmented-foam cushions that are not designed for pressure ulcer prevention.
The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of pressure-reducing cushions as a preventive measure against sitting-acquired pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.
- Conditions
- Pressure Ulcer
- Being tested
- Skin Protection Wheelchair Seat Cushion, Segmented Foam Wheelchair Seat Cushion
- Keywords
- pressure ulcer
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Protection Wheelchair Seat CushionDevice
Also called ROHO, Quadtro, Sunrise Medical, Jay2 Deep Contour, Invacare, Infinity
Cushion receiving CMS code for Skin Protection Wheelchair Cushion
Segmented Foam Wheelchair Seat CushionDevice
General use class wheelchair seat cushion
| Study group | Role | What they receive |
|---|---|---|
| Segmented Foam Cushion | Active comparator | Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes Receives: Device: Segmented Foam Wheelchair Seat Cushion |
| Skin Protection Cushion | Experimental | Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion Receives: Device: Skin Protection Wheelchair Seat Cushion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting-induced Pressure Ulcers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, David Brienza, University of Pittsburgh
- Investigators
- David M Brienza, Ph.D., Principal investigator, University of PittsburghSheryl Kelsey, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178126
- Sponsor's protocol ID
- 0403061
- Other IDs
- R01HD041490
- Status last verified
- Apr 2017
- First submitted
- 13 Sep 2005
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brienza D, Kelsey S, Karg P, Allegretti A, Olson M, Schmeler M, Zanca J, Geyer MJ, Kusturiss M, Holm M. A randomized clinical trial on preventing pressure ulcers with wheelchair seat cushions. J Am Geriatr Soc. 2010 Dec;58(12):2308-14. doi: 10.1111/j.1532-5415.2010.03168.x. Epub 2010 Nov 10.
PubMed 21070197
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT on Preventing Pressure Ulcers With Seat Cushions
- ClinicalTrials.gov ID
- NCT00178126
- Acronym / sponsor ID
- 0403061
- Conditions
- Pressure Ulcer
- Keywords
- pressure ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Mar 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 2 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of pressure-reducing cushions as a preventive measure against sitting-acquired pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.
Detailed description
Pressure ulcers (aka pressure sores, bed sores and decubitus ulcers) are a significant healthcare problem for the growing number of United States elderly long-term care (LTC) residents. Pressure ulcers (PU) diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs.
Despite Federal preventive mandates for the long-term care (LTC) setting, widespread non-compliance occurs. The last three Centers for Medicare and Medicaid Services (CMS) LTC surveys showed a cumulative increase of 21% in the number of citations issued for failure to provide proper intervention to prevent or treat pressure ulcers. Costs for the management of PU in the US likely exceed $6.4 billion annually with a prevalence of approximately 28% in the LTC population.
Estimates of the number of sitting-acquired PU in the elderly, at-risk population range from 36-50%. Several studies, including our own pilot investigation, support these estimates and have suggested that the use of wheelchair cushions designed to reduce interface pressure will reduce the incidence of sitting-acquired PU. Despite this evidence, elderly wheelchair users are not routinely evaluated for seating and positioning needs as definitive studies have not been completed to justify funding for such seating interventions. Consequently, elderly Medicare beneficiaries are being denied access to medically necessary and clinically appropriate interventions and instead are most frequently provided with convoluted or segmented-foam cushions that are not designed for pressure ulcer prevention.
The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of pressure-reducing cushions as a preventive measure against sitting-acquired pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmented Foam Cushion | Active comparator | Device: Segmented Foam Wheelchair Seat CushionReceive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes |
| Skin Protection Cushion | Experimental | Device: Skin Protection Wheelchair Seat CushionReceive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 and older
- use wheelchair > 6 hours per day
- no pressure ulcer on sitting surface
- Braden score of 18 or less
- combined activity and mobility Braden sub-score of 5 or less
Key exclusion criteria (4 listed)
- Body Weight exceeds 250 lbs.
- Hip Width exceeds 20 inches
- does not meet all criteria of seating needs assessment
- current use of cushioning material or wheelchair better than study devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Protection Wheelchair Seat CushionAlso: ROHO, Quadtro, Sunrise Medical, Jay2 Deep Contour, Invacare, InfinityCushion receiving CMS code for Skin Protection Wheelchair Cushion | Device | Skin Protection Cushion |
| Segmented Foam Wheelchair Seat CushionGeneral use class wheelchair seat cushion | Device | Segmented Foam Cushion |
Primary outcome
Sitting-induced Pressure Ulcers
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21070197Brienza D, Kelsey S, Karg P, Allegretti A, Olson M, Schmeler M, Zanca J, Geyer MJ, Kusturiss M, Holm M. A randomized clinical trial on preventing pressure ulcers with wheelchair seat cushions. J Am Geriatr Soc. 2010 Dec;58(12):2308-14. doi: 10.1111/j.1532-5415.2010.03168.x. Epub 2010 Nov 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Brienza, Ph.D. principal investigator
University of Pittsburgh
Sheryl Kelsey, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Protection Wheelchair Seat Cushion and Segmented Foam Wheelchair Seat Cushion in people with Pressure Ulcer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sitting-induced Pressure Ulcers (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00178126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.