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Abstract

. Efficacy of splint with heel off-loaded in children with lower limbs plaster cast. Randomised open label trial. Plasters cast are medical devices widely used in paediatric orthopaedics; however, few studies have addressed the occurrence and prevention of device-related complications. To evaluate whether positioning a custom made splint with heel off-loaded, would relieve pain, reduce care interventions, the materials to maintain heel unloading position and, at the same time, improve comfort and reduce pressure sores in children with lower limb plaster. Children enrolled in the study were randomised to splint, provided with a custom made splint positioned underneath the lower limb plaster after surgery; in the second group (control) the plaster position was maintained with cushions. A total of 57 children were enrolled from November 2014 to August 2015, 29 in the treatment group (50.8%) and 28 in the control group (49.2%). Pain median levels were 4 (splint) vs. 5 (control) p=ns; mean number of care intervention was 2.1 (splint) vs. 5.2 (control) p<0.0005; materials used were 1.3 (splint) vs. 2.8 (control) p<0.0005; perceived comfort was 8.9 (splint) vs. 7.6 (control) p<0.001. A difference in the total number of pressure sores was observed with 1 case in the splint group vs. 5 cases in the control group RR 0.21 (IC 95% -1.88-2.29; P 0.079). The use of splint is effective in reducing care intervention the use of other materials and in improving comfort, but not in relieving pain.