OBJECTIVE: To verify the application safety of medical anti-adhesion modified chitosan (Baifeimi) in cardiac surgery. METHODS:From August to December 2010, 42 patients undergoing surgery for congenital heart disease, valvular heart disease or ischemic heart disease were selected and divided into testing (n = 22) and control (n = 20) groups. After complete intraoperative hemostasis, two sheets of anti-adhesion modified chitosan (Baifeimi) were placed on the surface of heart and vessels in the testing group and then chest was closed. And the control group underwent routine chest closing without an application of Baifeimi. The systemic and local reactions and drainage fluid were observed. The postoperative drainage fluid was subject to bacteria culture. Blood routines and laboratory tests at preoperation and Day 1 and Week 1 postoperation were performed to evaluate the changes of chemical, biological and immunological parameters. RESULTS: There was no occurrence of systemic reaction, local inflammation or exudation.Wounds were healed at Phase I. The drainage fluid of pericardium and mediastina had no significant intergroup difference. Drainage was unobstructed in the testing group. A comparison of two groups revealed that the differences of aspartate aminotransferase ( (24 ± 17) vs (40 ± 22) U/L), preoperative and postoperative immunoglobulin A( (1.9 ± 0.7) vs (2.9 ± 1.4) g/L, (2.3 ± 0.9) vs (3.3 ± 1.5) g/L) were statistically significant (all P < 0.05). But the average values of both group stayed within a normal range without clinical significance while other indices had no significant difference. The bacteria cultures of all patients in the control group were negative. CONCLUSIONS: Anti-adhesion modified chitosan is both convenient and safe for clinical application. The duration of cardiac surgery is not extended.No systemic or local adverse event is reported. There is no interference of hepatic, renal or immune functions.
RCT Entities:
OBJECTIVE: To verify the application safety of medical anti-adhesion modified chitosan (Baifeimi) in cardiac surgery. METHODS: From August to December 2010, 42 patients undergoing surgery for congenital heart disease, valvular heart disease or ischemic heart disease were selected and divided into testing (n = 22) and control (n = 20) groups. After complete intraoperative hemostasis, two sheets of anti-adhesion modified chitosan (Baifeimi) were placed on the surface of heart and vessels in the testing group and then chest was closed. And the control group underwent routine chest closing without an application of Baifeimi. The systemic and local reactions and drainage fluid were observed. The postoperative drainage fluid was subject to bacteria culture. Blood routines and laboratory tests at preoperation and Day 1 and Week 1 postoperation were performed to evaluate the changes of chemical, biological and immunological parameters. RESULTS: There was no occurrence of systemic reaction, local inflammation or exudation.Wounds were healed at Phase I. The drainage fluid of pericardium and mediastina had no significant intergroup difference. Drainage was unobstructed in the testing group. A comparison of two groups revealed that the differences of aspartate aminotransferase ( (24 ± 17) vs (40 ± 22) U/L), preoperative and postoperative immunoglobulin A( (1.9 ± 0.7) vs (2.9 ± 1.4) g/L, (2.3 ± 0.9) vs (3.3 ± 1.5) g/L) were statistically significant (all P < 0.05). But the average values of both group stayed within a normal range without clinical significance while other indices had no significant difference. The bacteria cultures of all patients in the control group were negative. CONCLUSIONS: Anti-adhesion modified chitosan is both convenient and safe for clinical application. The duration of cardiac surgery is not extended.No systemic or local adverse event is reported. There is no interference of hepatic, renal or immune functions.