Comparing two kinds of bioabsorbable steroid implants following endoscopic sinus surgery：a randomed，controlled，single-blind，prospective，multi-center study

Abstract

Objective：To assess the safety and effectiveness of a bioabsorbable steroid implant which produced by BREATH MEDICAL following endoscopic sinus surgery.

Methods:A prospective, multi-center, randomized, single-blind,controlled design method was adopted, a total of 180 cases were enrolled, and there were 6 clinical trial institutions. The test group used the stent produced by BREATH MEDICAL.The control group used the stent produced by PUYI BIOTECHNOLOGY which was the first one used in China. Observe the clinical evaluation indicators of the subjects during the treatment process after1 week, 1 month, 2 month and 3 month   respectively.

Results:There were no statistical significance in the disease control evaluation results, visual analog scale(VAS) results, and nasal endoscopy Lund-Kennedy score between the test group and the control group (P>0.05). The Sino-Nasal Outcome Test-20(SNOT-20): there was no significant difference in the SNOT-20 measured at the 1 week, 1 month, and 2 month postoperative (P>0.05), but there was a significant difference at the 3 month postoperative (P<0.05). The SNOT-20 measures in the test group was higher than that in the control group. The safety evaluation results showed that the laboratory tests (blood routine, urine routine, blood biochemistry-liver and kidney function), electrocardiogram, and eye examination (fundusscope and ophthalmology) of the two groups before surgery and 3 month after surgery has no significant difference(P>0.05).And there was no statistical difference in the occurrence of adverse events and serious adverse events between the two groups (P>0.05).

Conclusions:This study demonstrated the safety and effectiveness of the bioabsorbable steroid implant produced by BREATH MEDICAL and it can be used in clinical.