RCTs, the ‘gold standard’ in research are complex to undertake and so are rare in the field of wound care. Such studies are designed to evaluate the effectiveness of one product, or one modality compared to another.
Comparing the effectiveness of a specialized alternating pressure air mattress replacement system and an air-fluidized integrated bed in the management of post-operative flap patients. A pilot RCT (Finnegan M 2007)
- Nimbus 3 Professional APRM (ArjoHuntleigh) vs. Clinitron® Rite Hite® Air Fluidized Bed (Hill-Rom Inc.).
- Compared surgical site integrity, pressure ulcer incidence and cost of bed/mattress provision in 40 randomly assigned subjects undergoing major reconstructive surgery.
- Excellent clinical outcomes were observed in both groups but the cost of air fluidized therapy was double that for Nimbus 3 Professional mattress.
- Subjects expressed a clear preference for Nimbus 3 Professional mattress in terms of comfort, independent mobility, temperature and overall satisfaction.
Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis (Iglesias C et al 2006)
- 1971 subjects within 11 acute care hospitals (UK) were randomly assigned to a Mattress Replacement (MR) or a mattress overlay.
- Alternating pressure mattresses were 80% more likely to be cost saving compared to mattress overlays, mainly due to reduced length of stay in hospital and a delay in time to ulceration.
- MR's were more acceptable to patients than overlays.
Note: this study was independently funded and included a range of different alternating support surfaces including Nimbus 3 mattress.
Prospective randomised controlled trial on use of pressure decreasing interfaces in ICU patients (Malbrain ML et al 2004)
- Nimbus 3 mattress vs. ROHO® mattress (ROHO Inc.).
- Compared pressure ulcer outcomes in 16 randomly assigned subjects.
- In the Nimbus 3 group 62.5% of subjects had existing wounds of which 82% improved; no ulcers improved in the ROHO group.
- The Nimbus 3 mattress was shown to be the more effective device.
Randomised controlled trial of two pressurerelieving systems (Russell L et al 2000)
- Nimbus 3 mattress vs. Cairwave® Therapy System (Pegasus UK).
- Compared healing rates in 141 randomly assigned elderly care subjects.
- Equally effective for sacral ulcers with improved outcomes for heel ulcers in the Nimbus 3 mattress group.
- Both systems equally comfortable and a high level of subject acceptability.