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find Author "WANGDe" 1 results
  • Effectiveness and Safety of Bioabsorbable Anti-adhesive Pericardial Substitute to Eliminate Pericardial Adhesion: A Randomized Controlled Trial

    ObjectiveTo explore effectiveness and safety of bioabsorbable anti-adhesive pericardial substitute (GM042) to eliminate pericardial adhesion. MethodsEighty patients who were expected to undergo multistage cardiac surgery in three years were randomly divided into a trial group (40 patients) and a control group (40 patients). The mean age of the patients in the trial group was 1.79±1.72 years and 1.63±1.52 years in the control group. Finally, 73 patients were included with 36 patients (13 females and 23 males) in the trial group and 37 patients (20 males and 17 females) in the control group. The trial group used GM042 to fill the pericardium defect at the first surgery while the control group didn't. The manipuility, safety, and the anti-adhesive role of GM042 were evaluated. ResultsThere was no significant difference in clinical indexes between at first surgery and six months after surgery in the trial group. There was no significant adverse event correlated to GM042. GM042 presented fine maneuverability during surgery. The adhesive score of the trial group was significantly lower than that of the control group (P<0.05). Adhesion score, pericardiac thickening, calcification, and visibility of heart surface structures were better in the trial group than those in the control group (P<0.05). ConclusionGM042 presented anti-adhesion effect and safety in cardiac surgery. Therefore, it's applicable to patients requiring re-operation.

    Release date:2016-10-19 09:15 Export PDF Favorites Scan
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