Lodge Andrew J, Wells Winfield J, Backer Carl L, O'Brien James E, Austin Erle H, Bacha Emile A, Yeh Thomas, Decampli William M, Lavin Philip T, Weinstein Samuel
Division of Thoracic and Cardiovascular Surgery, Duke University Medical Center, Durham, North Carolina, USA.
Ann Thorac Surg. 2008 Aug;86(2):614-21. doi: 10.1016/j.athoracsur.2008.04.103.
Adhesions encountered in reoperative cardiac surgery can prolong operating time and increase risk. This study was designed to evaluate the ability of a novel bioresorbable barrier film to reduce adhesions in infants.
A comparative, evaluator-masked, randomized, multicenter study design was used. Before chest closure, infants undergoing initial sternotomy for eventual staged palliative cardiac operations were randomized to barrier film placement (n = 54) or control (no treatment, n = 49) at 15 centers. At repeat sternotomy 2 to 13 months later, the extent and severity of adhesions at the investigational surgical site (ISS) were assessed. A four-grade adhesion severity scoring system was standardized as follows: none, mild (filmy, noncohesive, requiring blunt dissection), moderate (filmy, noncohesive, requiring sharp and blunt dissection), and severe (dense, cohesive, requiring extensive sharp dissection).
There were significantly fewer patients with any severe adhesions (29.6% vs 71.4%, p < 0.0001), and a significantly lower percentage of the ISS had severe adhesion involvement (21.1 +/- 36.9% vs 49.5 +/- 42.7%, p = 0.0005) in the barrier group compared with the control group at the second sternotomy. Delayed chest closure (p = 0.0101), Norwood procedure (p = 0.0449), and cardiopulmonary bypass (p = 0.0001) were univariate risk factors for more severe adhesions. Multivariate analysis revealed only control group to be a significant risk factor for more severe adhesions (p = 0.003). There were no statistically significant differences in adverse events between the groups. No adverse events were definitely attributed to the study device.
Use of a novel bioresorbable film was safe and effective in reducing the extent and severity of postoperative adhesions in infants undergoing repeat median sternotomy.
再次心脏手术中遇到的粘连会延长手术时间并增加风险。本研究旨在评估一种新型生物可吸收屏障膜减少婴儿粘连的能力。
采用比较性、评估者盲法、随机、多中心研究设计。在关闭胸腔前，15个中心将最终接受分期姑息性心脏手术而首次行胸骨切开术的婴儿随机分为屏障膜放置组（n = 54）或对照组（不治疗，n = 49）。在2至13个月后再次行胸骨切开术时，评估研究手术部位（ISS）粘连的范围和严重程度。一种四级粘连严重程度评分系统标准化如下：无、轻度（薄膜状、无粘连，需钝性分离）、中度（薄膜状、无粘连，需锐性和钝性分离）和重度（致密、粘连，需广泛锐性分离）。
与对照组相比，在第二次胸骨切开术时，屏障膜组有任何重度粘连的患者明显更少（29.6%对71.4%，p < 0.0001），且ISS有重度粘连累及的百分比明显更低（21.1 +/- 36.9%对49.5 +/- 42.7%，p = 0.0005）。延迟关胸（p = 0.0101）、诺伍德手术（p = 0.0449）和体外循环（p = 0.0001）是粘连更严重的单因素风险因素。多因素分析显示只有对照组是粘连更严重的显著风险因素（p = 0.003）。两组之间不良事件无统计学显著差异。没有不良事件明确归因于研究器械。
使用新型生物可吸收膜在减少接受再次正中胸骨切开术的婴儿术后粘连的范围和严重程度方面是安全有效的。
