Efficacy and Safety of DeShuTuo Versus Sensura Two-Piece Ostomy Appliance in Colostomy:A Randomized,Open-Label,Parallel,Positive-Controlled,Multicenter,Non-Inferiority Clinical Trial
Objective:To evaluate the efficacy and safety of DeShuTuo two-piece ostomy appliance in patients with colostomies and whether they are non-inferior to Sensura two-piece ostomy appliance.Methods:A randomized,open,parallel,positive-controlled,multicenter,noninferiority trial was conducted in 73 patients with colostomies who were randomized to the use of either a DeShuTuo or a Sensura two-piece ostomy bag.The primary outcome was the absence of peristomal dermatitis,and the secondary outcomes included the degree of leakage,the average duration of stoma base use,and patient satisfaction.Results:The percentage of no peristomal dermatitis was 69.4%(95%CI,51.9%-83.7%)in the DeShuTuo group and 66.7%(95%CI,49.0%-81.4%)in the Sensura group,with no statistical difference between the two groups(P=0.8219).There was no statistical difference between the two groups in terms of leakage score,duration of stoma base use,participant satisfaction,or adverse events.Conclusion:Compared with the Sensura two-piece ostomy bag,the DeShuTuo two-piece ostomy bag was non-inferior in terms of peristomal dermatitis,degree of leakage,duration of stoma base use,and participant satisfaction.