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

PHASE3CompletedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

December 1, 2017

Study Completion Date

December 1, 2017

Conditions
Chronic RhinosinusitisPostoperative Nasal Synerchia
Interventions
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

Trial Locations (1)

10600

Faculty of Medicine Ramathibodi Hospital, Bangkok

All Listed Sponsors
lead

Mahidol University

OTHER

NCT02106793 - Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis | Biotech Hunter | Biotech Hunter