Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
- Registration Number
- NCT01197612
- Lead Sponsor
- University of Michigan
- Brief Summary
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- hyposmia and nasal obstruction for >12 weeks
- bilateral nasal polyposis
- candidate for surgery
Exclusion Criteria
- immunocompromised
- non-English speaking
- prisoner
- pregnant/lactating
- will not attend follow up appointments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm; nostrils as experimental and comparator pulmicort each subject serves as their own control with one nostril being treated with pulmicort and one not
- Primary Outcome Measures
Name Time Method Olfaction 3 weeks post-operation will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification
- Secondary Outcome Measures
Name Time Method Sinonasal Health 24 weeks post operation Assessed with Perioperative Sinus Endoscopy (POSE) score
Olfaction 24 weeks post operation Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States