New Adhesive Composite Barrier in Pediatric Cardiac Surgery: A Pilot Clinical Study

Objectives This study aims to assess the effectiveness of a new adhesive composite barrier for preventing scars between the sternum and the intracardiac structures. Methods A pilot, prospective, single‐center, randomized controlled study encompassing neonates with ventricular septal defect who received staged correction between January and September 2024. Patients ( n = 20) were divided into two groups. After pulmonary artery banding, the study group ( n = 10) had the new adhesive composite barrier implanted in the pericardium before the sternum was closed ( n = 10). The control group ( n = 10) had no barrier. After 3–6 months, all patients had complete correction of the ventricular septal defect, and the barrier was explanted in the study group. We recorded palliative procedure duration and continuously monitored clinical data and resternotomy duration. The histological severity of fibrosis and inflammatory reaction was assessed in the study group. Results No patients died during the study. The palliative procedure duration, length of stay in the ICU, and length of hospitalization did not differ between the groups. During complete correction, the severity of the adhesion process was estimated in both groups and made up 1.6 ± 0.6 points in the study group and 2.3 ± 0.6 points ( p < 0.04) in the control group. The length of hospital stay after VSD repair was the same ( p = 0.84). The overall degree of fibrotic changes was lower in the study group: 1.9 ± 0.3 points as compared to 2.3 ± 0.4 ( p = 0.049) in the control group. Conclusions The new adhesive composite Reperen‐based barriers were easily separated from the surrounding tissues without adhering to the sternum or intracardiac structures and demonstrate high potential when used as adhesion barriers in cardiac surgery.