Background: 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. Methods: 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). Results: 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. Conclusions: 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.
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine