MedTrace Logo

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

NCT02106793 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2018-05-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Pawin Numthavaj, M.D. · Ramathibodi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02106793 on ClinicalTrials.gov