A prospective, randomized controlled trial
Chitang J. Joshi MD,Miguel Carabano MD,Laura C. Perez MD,Peter Ullrich,Abbas M. Hassan MD,Rou Wan MD,Jing Liu MD,Rachna Soriano DO,Robert D. Galiano MD, FACS
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-Fluidized 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 two weeks after surgery and the rate of acceptability of the device. 38 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 … read more