BACKGROUND: Adhesions encountered during reoperative cardiac surgery can prolong operative time and increase operative risk. The purpose of this clinical study was to investigate the antiadhesion property of a synthetic bioabsorbable polymer spray after cardiac reoperations in infants. METHODS: A prospective randomized double-blinded study was designed. Forty infants requiring staged cardiac operations were randomly allocated to a study group (n = 20) or a control group (n = 20). The appropriate volume of the polymer was sprayed onto the mediastinal surfaces before chest closure after the first surgical procedure in the study group. At reoperation, adhesions were evaluated by a blinded investigator following a 5-grade scoring system. Five predetermined anatomic areas were scored. Incision to extracorporeal circulation time was also analyzed. RESULTS: In all, 40 subjects were enrolled into the study. Four babies died before the second operation. Three others were missed for reevaluation. The control group (n = 16) had longer incision to extracorporeal circulation time (38 ± 10 minutes) than the study group (n = 17; 23 ± 6 minutes; p < 0.001). The control subjects had significantly more severe adhesions than the study group at all five mediastinal areas: (1) retrosternal (p < 0.001); (2) base of the heart (large vessels [p < 0.05]); (3) right side (p < 0.01); (4) left side (p < 0.02); and (5) diaphragmatic side of the mediastinum (p < 0.001). CONCLUSIONS: The use of synthetic bioabsorbable polymer sealant spray at the end of primary pediatric cardiac surgery reduces the intensity of mediastinal adhesions and the reentry time in infants undergoing repeat median sternotomy.
RCT Entities:
BACKGROUND: Adhesions encountered during reoperative cardiac surgery can prolong operative time and increase operative risk. The purpose of this clinical study was to investigate the antiadhesion property of a synthetic bioabsorbable polymer spray after cardiac reoperations in infants. METHODS: A prospective randomized double-blinded study was designed. Forty infants requiring staged cardiac operations were randomly allocated to a study group (n = 20) or a control group (n = 20). The appropriate volume of the polymer was sprayed onto the mediastinal surfaces before chest closure after the first surgical procedure in the study group. At reoperation, adhesions were evaluated by a blinded investigator following a 5-grade scoring system. Five predetermined anatomic areas were scored. Incision to extracorporeal circulation time was also analyzed. RESULTS: In all, 40 subjects were enrolled into the study. Four babies died before the second operation. Three others were missed for reevaluation. The control group (n = 16) had longer incision to extracorporeal circulation time (38 ± 10 minutes) than the study group (n = 17; 23 ± 6 minutes; p < 0.001). The control subjects had significantly more severe adhesions than the study group at all five mediastinal areas: (1) retrosternal (p < 0.001); (2) base of the heart (large vessels [p < 0.05]); (3) right side (p < 0.01); (4) left side (p < 0.02); and (5) diaphragmatic side of the mediastinum (p < 0.001). CONCLUSIONS: The use of synthetic bioabsorbable polymer sealant spray at the end of primary pediatric cardiac surgery reduces the intensity of mediastinal adhesions and the reentry time in infants undergoing repeat median sternotomy.