A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of the Fluid Immersion Simulation System versus an Air Fluidized Bed System in the Acute Post-Operative Management of Pressure Ulcers: Midpoint Study Analysis

Background: Use of pressure offloading support surfaces is considered standard of care for pressure ulcers by most surgeons.  The Fluid Immersion Simulation System (FIS)(Dolphin, Joerns Healthcare) has shown significant results in previous studies.  

Purpose: We compared it, for the first time, with a representative Air-Fluidized Bed (AFB) (Clinitron).

Methods: This trial was performed over 36 months, in which 60 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 2 weeks after closure.  

Results: FIS group contained 29 subjects, and the AFB group contained 31. Flap failure rate was similar between groups (8.0% vs. 14.8%; p=0.44).  Complication rate( Flap failure, bleeding, infections, dehiscence, skin irritation, etc) was higher in the FIS group (54.6% vs 19.0%; p=0.011).  Nurse and patient acceptability had favorable mean scores in the FIS compared to AFB (Nurse: 1.56 vs 1.80; p=0.062; Patient: 2.0 vs. 2.09; p=0.58). 

Conclusion: Despite having more complications on the FIS than the AFB group, the status of the wound at the end of the study period was similar in both groups.  We will have to further analyze the recurrence rate during one-year period once we have concluded the study.