Anti-adhesive effect of a thermosensitive poloxamer applied after the removal of nasal packing in endoscopic sinus surgery: A randomised multicentre clinical trial

摘要

Objective: To compare the efficacies of a thermosensitive poloxamer (TPX) and Merogel in preventing adhesion applied after the removal of nasal packing in endoscopic sinus surgery as a non-inferiority trial. Design: Randomised, multicentre, single-blind, active-controlled, matched-pair study. Setting: Yonsei University Gangnam Severance Hospital, Korea University Guro Hospital. Participants: A total of 70 patients were enroled and underwent endoscopic sinus surgeries. Four of the patients did not complete their follow-up. Analysis of the 66 enroled patients having completed postoperative assessment was performed. The severity of rhinosinusitis was graded with a Lund-McKay CT score, and only those with bilateral disease and a CT score difference ≤2 between sinuses were included. Main outcome measures: An independent rhinologist from a third institution through a blinded assessment with digital photoendoscopy of the middle meati bilaterally taken postoperatively. Results: In the blinded assessment, thermosensitive poloxamer (anti-adhesion rate: 92%) was similar to Merogel (anti-adhesion rate: 89%). Evaluation of the presence and grade of adhesion, oedema, and infection in the middle meatus revealed no significant differences between the thermosensitive poloxamer group and the Merogel group at all postoperative periods. Conclusion: Anti-adhesive effects of thermosensitive poloxamer are similar to those of Merogel. Therefore, thermosensitive poloxamer can be considered a safe alternative to Merogel for preventing adhesion in patients undergoing endoscopic sinus surgeries, and further evaluation of thermosensitive poloxamer as an anti-adhesive and primary packing material compared with the control using no packing is needed.