Medicine · 2022
Treatment of anal fistula using a decellularized porcine small intestinal submucosa plug: A non-inferiority trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Chen Zhao Wen, Zheng Yi, Zhao Rong, Wang Zhen Jun
Аннотация
BACKGROUND: Using small intestinal submucosa (SIS) has increasingly become the standard method for the treatment of anal fistula. The porcine SIS manufactured by Biosis Healing is a novel biological material that has several advantages for the safe and effective repair of tissues. Our study aimed to verify the efficacy and safety of the decellularized porcine SIS (VIDASIS) anal fistula plug.
METHODS: We conducted a non-inferiority multicenter, randomized, controlled clinical trial involving patients with chronic anal fistula. Patients from 3 centers across China were randomized 1:1 to Biosis SIS vs commercial SIS. The primary endpoint was the healing rate and secondary endpoints included recurrence within 6 months, rate of copracrasia, healing time, pain using a visual analog scale, and patient and doctor satisfaction.
RESULTS: A total of 186 patients were randomized. Of these, 82 patients in the Biosis SIS and 81 in the control (commercial) SIS completed the trial (per-protocol set). The healing rate at the 6-month follow-up (full analysis set) was 92.0% for the Biosis SIS and 89.8% for the control SIS (P = .620). The rate difference of 2.2% (full analysis set; 95% confidence interval: -6.4% and 10.7%, respectively) was within the pre-specified non-inferiority margin of -10%. There were no differences between the 2 groups with regard to the secondary endpoints. No serious adverse event or death occurred.
CONCLUSION: Our study shows that the VIDASIS anal fistula plug manufactured by the company Biosis Healing is safe and effective and is not inferior to existing commercial SIS materials.
METHODS: We conducted a non-inferiority multicenter, randomized, controlled clinical trial involving patients with chronic anal fistula. Patients from 3 centers across China were randomized 1:1 to Biosis SIS vs commercial SIS. The primary endpoint was the healing rate and secondary endpoints included recurrence within 6 months, rate of copracrasia, healing time, pain using a visual analog scale, and patient and doctor satisfaction.
RESULTS: A total of 186 patients were randomized. Of these, 82 patients in the Biosis SIS and 81 in the control (commercial) SIS completed the trial (per-protocol set). The healing rate at the 6-month follow-up (full analysis set) was 92.0% for the Biosis SIS and 89.8% for the control SIS (P = .620). The rate difference of 2.2% (full analysis set; 95% confidence interval: -6.4% and 10.7%, respectively) was within the pre-specified non-inferiority margin of -10%. There were no differences between the 2 groups with regard to the secondary endpoints. No serious adverse event or death occurred.
CONCLUSION: Our study shows that the VIDASIS anal fistula plug manufactured by the company Biosis Healing is safe and effective and is not inferior to existing commercial SIS materials.