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a Division of Thoracic and Cardiovascular Surgery, Duke University Medical Center, Durham, North Carolina
b Divison of Cardiothoracic Surgery, Childrens Hospital Los Angeles, Los Angeles, California
c Division of Cardiovascular-Thoracic Surgery, Children's Memorial Hospital, Northwestern University Feinberg School of Medicine, Chicago, Illinois
d Division of Cardiac Surgery, Children's Mercy Hospital, Kansas City, Missouri
e Cardiovascular and Thoracic Surgery, Kosair Children's Hospital and the University of Louisville, Louisville, Kentucky
f Department of Cardiac Surgery, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts
g Department of Cardiothoracic Surgery, Tulane University, New Orleans, Louisiana
h Congenital Heart Institute, Arnold Palmer Hospital for Children and Women, Orlando, Florida
i Boston Biostatistics Research Foundation, Framingham, Massachusetts
j Department of Cardiothoracic Surgery, Children's Hospital at Montefiore, Bronx, New York
Accepted for publication April 24, 2008.
* Address correspondence to Dr Lodge, Division of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Box 3340, Durham, NC 27710 (Email: andrew.lodge{at}duke.edu).
Presented at the Forty-fourth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2008.
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.
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