Randomised controlled trial comparing alternating pressure overlays with alternating pressure mattresses for pressure sore prevention and treatment
Completed
- Conditions
- Pressure soresSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN78646179
- Lead Sponsor
- Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1972
Inclusion Criteria
Patients aged > 55 years who are admitted to a vascular, orthopaedic or care of the elderly ward with an expected length of stay of at least 7 days AND who are completely immobile/have very limited mobility on admission; or have a pre-existing grade 1, 2 or 3 pressure sore on admission. Patients admitted before elective surgery who are expected to be completely immobile/have very limited mobility for at least 3 days after surgery may also be included.
Exclusion Criteria
Patients who have a pre-existing grade 4 or 5 pressure sore on admission, have participated in this trial previously or are unable/unwilling to give full informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence of a first or new sore at or above the level of superficial damage to the skin (break/blister) before discharge will be considered as a treatment failure.
- Secondary Outcome Measures
Name Time Method 1. Worsening/healing of existing sores<br>2. Patients' perceptions<br>3. Time to occurrence<br>4. Site of sore<br>5. Economic costs including those incurred in the treatment of pressure sores in the community, post-discharge<br><br>Skin assessments will be made daily by qualified attendant nursing staff and validated twice weekly by research nurses. <br><br>Health economic results comparing the costs and benefits of the expensive with the cheaper mattresses, will be expressed as incremental cost effectiveness ratios.