Analyze whether application of a theoretical reasoned and tested system with test subjects is preventive and costs effective.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of pressure ulcers on the Bedcare Plus system with 30%.
Secondary outcome
Reduction of superficial pressure ulcers related to transfers, reduction of
total cost prevention.
Background summary
Patients in Dutch nursing homes are suffering often with pressure ulcers.
Study objective
Analyze whether application of a theoretical reasoned and tested system with
test subjects is preventive and costs effective.
Study design
Prospective, randomized controlled study with 220 patient.
Intervention
About half the population will receive a visco-elastic foam mattress and the
other part the same type of mattress with the Bedcare Plus system on top of it.
Study burden and risks
There will be an inspection of the skin only once a week.
Hertog Hendriklaan 6
Oisterwijk 5062 CJ
NL
Hertog Hendriklaan 6
Oisterwijk 5062 CJ
NL
Listed location countries
Age
Inclusion criteria
1. Both genders, age >= 60 years, mentally competent or incompetent
2. Life expectation >3 month
3. Chronic patient in nursing home
4. No pressure ulcer in last 3 months
5. Braden score 6-15
6. Patient or his legal representative has read and signed Informed consent form before treatment
Exclusion criteria
1. Patient is participating in another wound study.
2. Patient has any condition(s) like need of hospital care, cancer, sepsis that seriously compromises the patient*s ability to complete this study according to the judgment of the MD
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Aanvraag loopt |
| CCMO | NL48831.028.14 |