Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2010-01-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
new bedsheet
new bedsheet
new bedsheet
sleeping 5 nights on the new bedsheet
conventional bedsheet
conventional bedsheet
conventional bedsheet
sleeping 5 nights on the conventional bedsheet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
new bedsheet
sleeping 5 nights on the new bedsheet
conventional bedsheet
sleeping 5 nights on the conventional bedsheet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Swiss Federal Laboratories for Material Sciences and Technology
UNKNOWN
Swiss Paraplegic Research, Nottwil
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anke Scheel, MD
Role: PRINCIPAL_INVESTIGATOR
Swiss Paraplegic Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Swiss Paraplegic-Centre
Nottwil, Canton of Lucerne, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Swiss Paraplegic Centre Nottwil
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-04
Identifier Type: -
Identifier Source: org_study_id