METHODS: This was a single-center pilot randomized trial. Patients with severe rib fractures were randomized into two groups: SSRF and nonoperative management. SSRF arm patients underwent surgical fixation in addition to the tenets of nonoperative management. Low-cost materials like stainless steel wires and braided polyester sutures were used for fracture fixation. The primary outcome was to assess the duration of hospital stay.
RESULTS: Twenty-two patients were randomized, 11 in each arm. Per-protocol analysis showed that the SSRF arm had significantly reduced duration of hospital stay (22.6 ± 19.1 d versus 7.9 ± 5.7 d, P value 0.031), serial pain scores at 48 h and 5 d (median score 5, IQR (3-6) versus median score 7, IQR (6.5-8), P value 0.004 at 48 h and median score 2 IQR (2-3) versus median score 7 IQR (4.5-7) P value 0.0005 at 5 d), significantly reduced need for injectable opioids (9.9 ± 3.8 mg versus 4.4 ± 3.4 mg, P value 0.003) and significantly more ventilator-free days (19.9 ± 8.7 d versus 26.4 ± 3.2 d, P value 0.04). There were no statistically significant differences in the total duration of ICU stay (median number of days 2, IQR 1-4.5 versus median number of days 7, IQR 1-14, P value 0.958), need for tracheostomy (36.4% versus 0%, P value 0.155), and pulmonary and pleural complications.
CONCLUSIONS: SSRF with low-cost materials may provide benefits similar to standard rib plating systems and can be used safely in resource-poor settings.
方法:这是一项单中心随机试验。严重肋骨骨折患者被随机分为两组:SSRF和非手术治疗。除了非手术治疗的原则外,SSRF手臂患者还接受了手术固定。低成本材料,如不锈钢丝和编织聚酯缝线用于骨折固定。主要结果是评估住院时间。
结果:22例患者被随机分组,每个手臂11。按方案分析显示,SSRF组的住院时间显着减少(22.6±19.1d对7.9±5.7d,P值0.031),48h和5d的连续疼痛评分(中位数评分5,IQR(3-6)与中位数评分7,IQR(6.5-8),48h时的P值0.004,中位数评分2IQR(2-3)与中位数评分7IQR(4.5-7)在5d时的P值0.0005),对可注射阿片类药物的需求显着减少(9.9±3.8mg与4.4±3.4mg,P值0.003),并且无呼吸机天数显着增加(19.9±8.7d对26.4±3.2d,P值0.04)。ICU住院总时间差异无统计学意义(中位天数2,IQR1-4.5与中位天数7,IQR1-14,P值0.958),需要气管造口术(36.4%对0%,P值0.155),肺和胸膜并发症。
结论:具有低成本材料的SSRF可能提供类似于标准肋骨电镀系统的好处,并且可以在资源贫乏的环境中安全使用。