Effectiveness of a fluid immersion simulation system in the acute post-operative management of pressure ulcers: A prospective, randomised controlled trial

Abstract

The fluid immersion simulation system (FIS) has demonstrated good clinical applicability. This is the first study to compare surgical flap closure outcomes of FIS with an air-fluidised bed (AFB), considered as standard of care. The success of closure after 14 days post-op was the primary endpoint. Secondary endpoints were incidences of complications in the first 2 weeks after surgery and the rate of acceptability of the device. Thirty-eight subjects were in the FIS group while 42 subjects were placed in the AFB group. Flap failure rate was similar between groups (14% vs. 12%; p = 0.84). Complications, notably dehiscence and maceration, were significantly higher in the FIS group (40% vs. 17%; p = 0.0296). The addition of a microclimate regulation device (ClimateCare®) to FIS for the last 43 patients showed a significant decrease in the rate of flap failure (71% vs. 16%; p = 0.001) and incidence of complications (33% vs. 0%; p = 0.011). There was no statistically significant difference between the FIS and air-fluidised bed (AFB) in the rate of acceptability (nurse acceptance: 1.49 vs. 1.72; p = 0.8; patient acceptance: 2.08 vs. 2.06; p = 0.17), which further illustrates the potential implementation of this tool in a patient-care setting. Our results show that the use of ClimateCare® in combination with FIS can be a better alternative to the AFB in surgical closure of pressure ulcers.