A novel bioresorbable film reduces postoperative adhesions after infant cardiac surgery
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Updated: Jul 3, 2026
A Translational Surgical Porcine Model for Postoperative Intra-Abdominal Adhesion Formation
Published on: March 13, 2026
Andrew J Lodge1, Winfield J Wells, Carl L Backer
1Division of Thoracic and Cardiovascular Surgery, Duke University Medical Center, Durham, North Carolina, USA. andrew.lodge@duke.edu
Insights
A novel bioresorbable film effectively reduced severe postoperative adhesions in infants undergoing repeat cardiac surgery. This barrier film proved safe and lowered the risk of adhesions during reoperative sternotomy.
Area of Science:
- Biomaterials Science
- Pediatric Cardiac Surgery
- Surgical Adhesion Prevention
Background:
- Postoperative adhesions complicate reoperative cardiac surgery, increasing operative time and risks.
- Infants undergoing staged palliative cardiac operations are susceptible to adhesion formation.
- Novel bioresorbable barrier films are being investigated to mitigate these adhesions.
Purpose of the Study:
- To evaluate the efficacy and safety of a new bioresorbable barrier film in reducing adhesions in infants undergoing repeat sternotomy.
- To compare adhesion severity and extent between infants receiving the barrier film and a control group.
Main Methods:
- A randomized, evaluator-masked, multicenter trial involving 103 infants undergoing initial sternotomy.
- Infants were randomized to receive barrier film placement (n=54) or no treatment (control, n=49) before chest closure.
- Adhesion severity at repeat sternotomy (2-13 months later) was assessed using a standardized four-grade scoring system.
Main Results:
- Significantly fewer patients in the barrier group experienced severe adhesions (29.6% vs 71.4%, p < 0.0001).
- The percentage of the surgical site with severe adhesions was lower in the barrier group (21.1% vs 49.5%, p = 0.0005).
- Multivariate analysis identified the control group as the sole significant risk factor for more severe adhesions (p = 0.003).
Conclusions:
- The novel bioresorbable film is safe and effective in minimizing postoperative adhesions in infants.
- Reduced adhesion severity and extent were observed in infants treated with the barrier film during repeat median sternotomy.
- No significant adverse events were attributed to the study device, supporting its safety profile.
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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