A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of the Fluid Immersion Simulation (FIS) System vs. an Air Fluidized Bed (AFB) System in the Acute Postoperative Management of Pressure Ulcers

Purpose: The Agency for Healthcare Research and Quality estimates more than 2.5 million individuals in the U.S. develop pressure ulcers annually. The medical management of pressure ulcers costs the health-care system $9.1 billion to $11.6 billion per year.

Optimization of modifiable risk factors for PU development and wound healing leads to quicker recovery and reduced health-care costs. Use of pressure off-loading support surfaces is considered standard of care for pressure ulcers by most surgeons. The Fluid Immersion Simulation System (FIS) has shown significant results in previous studies. We compared it, for the first time, with a representative air-fluidized bed (AFB).

Methods: This trial was performed, in which 80 subjects between 18 and 85 years of age, with ≤2 pressure ulcers and history of < 3 surgical closures underwent reconstruction by one surgeon. Subjects were randomly assigned to either treatment group for two weeks after closure.

Results: FIS group contained 40 subjects, and the AFB group contained 40. Flap failure rate was similar between groups (8.0% vs. 14.8%; p=0.44). Complication rate was higher in the FIS group (54.6% vs. 19.0%; p=0.011). Nurse and patient acceptability had better mean scores in the FIS compared to AFB (Nurse: 1.44 vs. 1.71; p=0.002; Patient: 1.98 vs. 2.00; p=0.364). The results obtained in this midpoint analysis show that the FIS can be an adequate alternative to the traditional AFB.