Study design, randomization, and outcomes
bone infection, diaphyseal femoral fracture, blood loss, malignancy, injuries, femoral fracture
BONE INFECTION, DEEP VEIN THROMBOSIS, BLOOD LOSS, PERIPHERAL VASCULAR DISEASE, BLEEDING DISORDERS
We conducted a randomized-controlled trial to identify the efficacy of SET in reducing perioperative blood loss for pediatric femoral surgery. We included pediatric patients aged 3–18 who were scheduled for elective femoral-related surgery in which the standard pneumatic tourniquet was not appropriate due to the surgical field obstruction (e.g., diaphyseal femoral fracture and distal femoral derotation osteotomy with plate osteosynthesis). These procedures are ideal candidates for a SET application. Although SET can be applied as high as on the upper thigh, it can only be used for surgical interventions located below the application area. Therefore, patients scheduled for proximal femoral surgeries (e.g., proximal femoral fracture and femoral varus osteotomy) were not included. Exclusion criteria included patients with peripheral vascular disease, a history of deep vein thrombosis, a history of bone infection and malignancy, bleeding disorders, and any associated injuries affecting further blood loss.After receiving informed consent, block-of-4 randomization was carried out using a computer-generated randomization sequence to allocate patients into two treatment arms equally; the treatment arm used SET, and the control arm didn’t use SET during the operation. Allocation was concealed using sequentially numbered, opaque, sealed envelopes (SNOSE) prior to making the incision. Treatment allocation was blinded to the patients and outcome accessor throughout the trial period.Hemoglobin level (Hb) was recorded at postoperative 24 and 72 h. The primary outcomes were perioperative total blood loss (TBL) and transfusion rate at 72 h after surgery. TBL was calculated based on the formula provided by Tzazairis et al. [The institutional review board (IRB) and departmental data safety monitoring board (DSMB) approved and monitored this study.