Spinal Cord InjuryNCT01943201
Low Friction Bed Sheet
A study testing new bedsheet and conventional bedsheet in people with Spinal Cord Injury and Pressure Ulcer, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Introduction: It is known that people with spinal cord injury (SCI) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Pressure Ulcer
- What is being tested?
- new bedsheet and conventional bedsheet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCI patients without a presser ulcer for the last 2 months
- Paraplegic and tetraplegic patients
- complete and incomplete lesion (AIS A, AIS B, AIS C, AIS D)
- caused by illness or traumatic event
- smoker and non-smoker
Who cannot join
- progressive disease
- severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic-Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Does a Low Friction Bed Sheet Optimize the Skin, Resistance and Physiology and Reduce the Risk for Pressure Ulcer?
Introduction:
It is known that people with spinal cord injury (SCI) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. It was the aim of the study to examine the effects of a specially developed low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients with SCI.
Read more
Method:
Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be recruited. Each patient spends five consecutive nights on the new, respectively, conventional bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS) concerning well-being, odour, perspiration and wrinkling. In addition, the patients are examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin blood circulation in the parasacral region.
- Conditions
- Spinal Cord Injury, Pressure Ulcer
- Being tested
- new bedsheet, conventional bedsheet
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new bedsheetDevice
Also called specially developed low-friction hospital bed sheet
sleeping 5 nights on the new bedsheet
conventional bedsheetDevice
Also called normal hospital bedsheet
sleeping 5 nights on the conventional bedsheet
| Study group | Role | What they receive |
|---|---|---|
| new bedsheet | Experimental | new bedsheet Receives: Device: new bedsheet |
| conventional bedsheet | Placebo comparator | conventional bedsheet Receives: Device: conventional bedsheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
well-being
linear questionnaire (visual analogue scale)
Measured: 1 day in the morning after sleeping on the new bed sheet
Secondary outcomes (4)
Skin redness
Measurement: Mexameter 10 points of measurement in the sacral region
Measured: 1 day in the morning after sleeping on the new bed sheet
Skin perfusion
Measurement: PeriFlux 10 points of measurement in the sacral region
Measured: 1 day in the morning after sleeping on the new bed sheet
Skin hydration
Measurement: Corneometer 10 points of measurement in the sacral region
Measured: 1 day in the morning after sleeping on the new bed sheet
Skin elasticity
Measurement: Cutometer 10 points of measurement in the sacral region
Measured: 1 day in the morning after sleeping on the new bed sheet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- Swiss Federal Laboratories for Material Sciences and Technology
- Responsible party
- Sponsor
- Investigators
- Anke Scheel, MD, Principal investigator, Swiss Paraplegic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943201
- Sponsor's protocol ID
- 2010-04
- Status last verified
- Nov 2016
- First submitted
- 11 Sep 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Low Friction Bed Sheet Optimize the Skin, Resistance and Physiology and Reduce the Risk for Pressure Ulcer?
- ClinicalTrials.gov ID
- NCT01943201
- Acronym / sponsor ID
- 2010-04
- Conditions
- Spinal Cord Injury, Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- Swiss Federal Laboratories for Material Sciences and Technology
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction:
It is known that people with spinal cord injury (SCI) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. It was the aim of the study to examine the effects of a specially developed low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients with SCI.
Method:
Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be recruited. Each patient spends five consecutive nights on the new, respectively, conventional bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS) concerning well-being, odour, perspiration and wrinkling. In addition, the patients are examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin blood circulation in the parasacral region.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new bedsheet | Experimental | Device: new bedsheetnew bedsheet |
| conventional bedsheet | Placebo comparator | Device: conventional bedsheetconventional bedsheet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- SCI patients without a presser ulcer for the last 2 months
- Paraplegic and tetraplegic patients
- complete and incomplete lesion (AIS A, AIS B, AIS C, AIS D)
- caused by illness or traumatic event
- smoker and non-smoker
Key exclusion criteria (2 listed)
- progressive disease
- severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)
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 |
|---|---|---|
| new bedsheetAlso: specially developed low-friction hospital bed sheetsleeping 5 nights on the new bedsheet | Device | new bedsheet |
| conventional bedsheetAlso: normal hospital bedsheetsleeping 5 nights on the conventional bedsheet | Device | conventional bedsheet |
Primary outcome
well-being
Time frame: 1 day in the morning after sleeping on the new bed sheet
linear questionnaire (visual analogue scale)
4 secondary outcomes
Skin redness
Time frame: 1 day in the morning after sleeping on the new bed sheet
Skin perfusion
Time frame: 1 day in the morning after sleeping on the new bed sheet
Skin hydration
Time frame: 1 day in the morning after sleeping on the new bed sheet
Skin elasticity
Time frame: 1 day in the morning after sleeping on the new bed sheet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Swiss Paraplegic Centre NottwilLink provided by the sponsor.
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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.
Anke Scheel, MD principal investigator
Swiss Paraplegic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new bedsheet and conventional bedsheet in people with Spinal Cord Injury and Pressure Ulcer, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 2 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 22 Nov 2016. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
well-being (time frame: 1 day in the morning after sleeping on the new bed sheet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2016.