Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swiss Federal Laboratories for Material Sciences and Technology | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new bedsheet | Experimental | new bedsheet |
|
| conventional bedsheet | Placebo Comparator | conventional bedsheet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| new bedsheet | Device | sleeping 5 nights on the new bedsheet |
|
| Measure | Description | Time Frame |
|---|---|---|
| well-being | linear questionnaire (visual analogue scale) | 1 day in the morning after sleeping on the new bed sheet |
| Measure | Description | Time Frame |
|---|---|---|
| Skin redness | Measurement: Mexameter 10 points of measurement in the sacral region | 1 day in the morning after sleeping on the new bed sheet |
| Skin perfusion | Measurement: PeriFlux 10 points of measurement in the sacral region |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anke Scheel, MD | Swiss Paraplegic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic-Centre | Nottwil | Canton of Lucerne | 6207 | Switzerland |
Not provided
| Label | URL |
|---|---|
| Swiss Paraplegic Centre Nottwil | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| conventional bedsheet | Device | sleeping 5 nights on the conventional bedsheet |
|
|
| 1 day in the morning after sleeping on the new bed sheet |
| Skin hydration | Measurement: Corneometer 10 points of measurement in the sacral region | 1 day in the morning after sleeping on the new bed sheet |
| Skin elasticity | Measurement: Cutometer 10 points of measurement in the sacral region | 1 day in the morning after sleeping on the new bed sheet |
| D014947 | Wounds and Injuries |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |