NCT02106793

Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis

Comparing Effect of Mitomicin C Versus Placebo for Prevention of Postoperative Endoscopic Sinus Surgery Synechia and Impact on Quality of Life in Thai Patients With Chronic Rhinosinusitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective * To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery * To validate the Thai version of disease-specific quality of life tool SNOT-22 Secondary objectives * To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo * To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo * To compare the side effects of Mitomicin C versus placebo

Conditions

• Chronic Rhinosinusitis
• Postoperative Nasal Synerchia

Interventions

Type	Name	Description
DRUG	Mitomicin C	Mitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side.
DRUG	Identical placebo solution	Identical placebo solution

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-04-08
• Last updated: 2018-05-23

Locations

1 site across 1 country: Thailand