Is lowering of shear and friction (cost)effective for prevention of pressure ulcers? A multicenter, prospective, controlled randomized clinical trial in Dutch nursing homes.
Phase 2
Completed
- Conditions
- BedsoresDecubitusPressure Ulcer10040790
- Registration Number
- NL-OMON42278
- Lead Sponsor
- Sense Textile BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Reduction of pressure ulcers on the Bedcare Plus system with 30%.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Reduction of superficial pressure ulcers related to transfers, reduction of<br /><br>total cost prevention.</p><br>