A Phase 3 interventional study of Mitomicin C and Identical placebo solution in Chronic Rhinosinusitis and Postoperative Nasal Synerchia, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-23.
Sponsored by Mahidol University · Phase 3, Interventional, and Treatment
Primary objective
Secondary objectives
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 224 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
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Patients must not have following diseases or conditions
Exclusion Criteria:
(None)
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: Mitomicin C
Identical placebo solution
Drug: Identical placebo solution
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.
Also known as: Mitomycin C
Identical placebo solution
Postoperative Synerchia
The primary outcome of interest is time to event, with the event as the occurrence of nasal synechia. The date of surgery will be used as the beginning date, and the last date will be the date that patient was defined as synechia, or the end of the study period if that patient does not have synechia on follow up.
Time frame: 1 year
Scoring of SNOT-22
Scoring of translated SNOT-22 disease-specific quality of life measurement
Time frame: 1 year
Clinical Symptom Score
Clinical symptom score of patients, measured by visual analog score which will be given by research nurse for a patient to fill in at baseline, 1 week, 1, 3, and 6 months.
Time frame: 6 months
SNOT-22
Disease-specific quality of life questionnaire SNOT-22 measurement which will be measured at baseline, 1 week, 1, 3, and 6 months.
Time frame: 6 months
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Mahidol University